#clinical trials monitor

[haleus]

What is Pharmacovigilance? Understanding Drug Safety and Risk Management

What is Pharmacovigilance? Pharmacovigilance (PV) is the science and practice of detecting, assessing, understanding, and preventing adverse effects or other drug-related problems. Its primary goal is to ensure that the benefits of medicinal products outweigh their risks, thus safeguarding public health.

This discipline extends across the entire lifecycle of a drug, from pre-market clinical trials to post-marketing surveillance, encompassing the global monitoring of medicinal products.

Core Objectives of Pharmacovigilance Identifying Adverse Drug Reactions (ADRs): PV seeks to detect adverse effects, especially those that are unexpected or serious, arising from the use of medicinal products.

Ensuring Drug Safety: By monitoring and managing risks, pharmacovigilance contributes to the safer use of medicines.

Educating Stakeholders: Healthcare providers, regulatory authorities, and patients are informed about potential risks and proper usage of drugs.

Regulatory Compliance: Pharmaceutical companies must adhere to international standards and report safety data to regulatory bodies like the FDA, EMA, and WHO.

Importance of Pharmacovigilance Protecting Patient Health: By identifying potential risks early, pharmacovigilance minimizes harm to patients and ensures the safety of medicinal products.

Supporting Regulatory Decisions: Comprehensive safety data help regulatory agencies make informed decisions about the approval, withdrawal, or restriction of drugs.

Enhancing Pharmaceutical Innovation: A robust PV framework fosters confidence in the pharmaceutical industry, encouraging innovation while ensuring public safety.

Global Harmonization: Pharmacovigilance facilitates uniform safety standards across countries, promoting international cooperation in drug safety monitoring.

Challenges in Pharmacovigilance Data Overload: The influx of safety data from clinical trials, real-world use, and social media presents challenges in effective monitoring.

Complex Regulations: Varying regulatory requirements across countries require significant expertise to navigate.

Technological Integration: Adopting advanced tools like AI and machine learning for signal detection and data analysis is a complex but necessary step forward.

Public Awareness: Educating patients and healthcare professionals about reporting adverse events remains a significant hurdle.

Technological Advances in Pharmacovigilance The integration of technology is revolutionizing pharmacovigilance. Tools such as artificial intelligence (AI), big data analytics, and machine learning are enhancing signal detection, enabling quicker identification of potential risks. Real-world evidence from wearable devices and electronic health records (EHRs) provides real-time insights into drug safety.

The Future of Pharmacovigilance As global healthcare systems evolve, pharmacovigilance will play an increasingly pivotal role. The focus will shift towards personalized medicine, where monitoring individual patient responses to drugs will become central. Additionally, greater emphasis on patient engagement and transparent communication will redefine the relationship between healthcare providers and patients.

Conclusion Pharmacovigilance is the cornerstone of drug safety, ensuring that the medicines we rely on are both effective and safe. By bridging the gap between pharmaceutical innovation and patient safety, it upholds the integrity of healthcare systems worldwide.

As technology and global collaboration continue to advance, pharmacovigilance will remain a critical field in protecting and improving public health, shaping a safer and more informed future for all.

[zenovelsworld]

Zenovel provides expert risk-based monitoring (RBM) services for GCP clinical trials, ensuring participant safety, data integrity, and efficient trial management. Our tailored solutions optimize monitoring efforts, improve efficiency, and maintain regulatory compliance. By focusing on critical data points and potential risk areas, we empower sponsors to proactively identify and mitigate risks, enabling them to make informed decisions and achieve successful study outcomes while safeguarding the well-being of trial participants.

[zenovel]

Driving Clinical Trial Success with Zenovel’s Risk-Based Monitoring Excellence

At Zenovel, we specialize in Risk-Based Monitoring (RBM) to ensure the highest standards of clinical trial success. Our approach combines centralized and on-site monitoring to safeguard participant safety, uphold data integrity, and ensure compliance with FDA and EMA regulations. By identifying, assessing, and mitigating risks, we help sponsors maintain trial credibility and protect human subject rights. With a focus on modern clinical trial methodologies, Zenovel empowers sponsors to achieve operational excellence and deliver high-quality outcomes. Partner with us to transform your clinical trials with precision and confidence.

[frontropharma]

Bridging Discovery to Delivery: Frontro Pharma's Expertise in Preclinical Studies

At Frontro Pharma, we specialize in facilitating the journey from groundbreaking scientific discovery to life-saving treatments through meticulous preclinical studies. Our dedicated team of research scientists boasts extensive experience across various therapeutic areas, ensuring that your drug development pathway benefits from tailored, high-quality preclinical data. By employing advanced in vitro and in vivo models, we provide detailed insights that enable informed decisions crucial to advancing your drug candidates into clinical development.

[lisalicharles]

Using Sugam to Improve Clinical Trial Monitoring Services

In the evolving landscape of healthcare and pharmaceuticals, clinical trials remain the cornerstone of developing new medical treatments and therapies. Effective monitoring of these trials is crucial to ensure compliance with regulatory standards, safeguard participant safety, and validate the integrity of data. This is where clinical trial monitoring services play an indispensable role. When coupled with platforms like Sugam, these services streamline the process, bringing efficiency and transparency to clinical research.

The Importance of Clinical Trial Monitoring

Clinical trial monitoring services encompass a range of activities designed to oversee the progress of a clinical trial. These activities include:

Ensuring Protocol Compliance: Monitors verify that the trial is conducted according to the pre-approved protocol. This includes ensuring adherence to the inclusion and exclusion criteria for participant selection, treatment administration, and data collection procedures.

Participant Safety: Monitors are responsible for the safety of the participants. They ensure that any adverse events are promptly reported and managed according to the regulatory guidelines.

Data Integrity and Quality: Accurate data is vital for the validity of a clinical trial. Monitors perform regular checks to ensure that the data collected is accurate, complete, and verifiable against source documents.

Regulatory Compliance: Clinical trials must comply with various regulatory requirements. Monitors ensure that the trial meets all necessary regulatory guidelines, which is crucial for the trial's approval and eventual publication.

The Role of Sugam in Clinical Trial Monitoring

Sugam, an online portal, has revolutionized the way clinical trials are managed and monitored in India. It serves as a single-window interface for various stakeholders in the pharmaceutical and clinical research sectors, including sponsors, researchers, and regulatory authorities. The integration of clinical trial monitoring services with Sugam offers several advantages:

Streamlined Application Process: Sugam simplifies the submission and approval process for clinical trials. Researchers and sponsors can submit their applications, amendments, and reports through the portal, reducing the paperwork and time required for approvals.

Real-time Monitoring: With Sugam, monitors can access real-time data and updates on the progress of a clinical trial. This enables them to identify and address issues promptly, ensuring that the trial stays on track.

Enhanced Transparency: Sugam enhances transparency by providing a comprehensive view of all ongoing and completed trials. This transparency builds trust among stakeholders and ensures that the trials are conducted ethically and efficiently.

Efficient Communication: The portal facilitates efficient communication between sponsors, researchers, and regulatory authorities. Any queries or concerns can be addressed swiftly, minimizing delays and misunderstandings.

Benefits of Integrating Clinical Trial Monitoring Services with Sugam

The integration of clinical trial monitoring services with Sugam offers a synergistic approach that enhances the overall efficiency and effectiveness of clinical trials. Some of the key benefits include:

Improved Compliance: The structured and systematic approach provided by Sugam ensures that all regulatory requirements are met, reducing the risk of non-compliance.

Cost and Time Efficiency: By streamlining the application and monitoring processes, Sugam reduces the time and cost associated with conducting clinical trials. This enables sponsors to bring new treatments to market faster.

Better Data Management: The digital nature of Sugam allows for better data management and analysis. Monitors can easily track and review data, ensuring that it meets the required standards.

Enhanced Participant Safety: With real-time monitoring and reporting capabilities, Sugam helps in ensuring the safety of participants by enabling quicker responses to any adverse events.

Conclusion

The integration of clinical trial monitoring services with platforms like Sugam marks a significant advancement in the field of clinical research. By streamlining processes, enhancing transparency, and ensuring compliance, this combination paves the way for more efficient and effective clinical trials. As the healthcare landscape continues to evolve, such innovations will be crucial in driving forward medical research and improving patient outcomes.

In conclusion, the synergy between clinical trial monitoring services and Sugam not only enhances the operational efficiency of clinical trials but also ensures that these trials meet the highest standards of safety, quality, and regulatory compliance. This integrated approach is poised to transform the future of clinical research, making it more robust and reliable.

[market-insider]

Strategic Insights into the Clinical Trial Investigative Site Network Market

The global clinical trial investigative site network market size is expected to reach USD 12.5 billion by 2030. Growing investments in pharmaceutical R&D, increasing demand for new therapies and complications associated with site management of clinical trials are some of the major factors driving the growth of the industry. There has been a consistent rise the clinical trials in the last 5 years. For instance, according to ClinicalTrials.gov, over 262,298 trials were registered in 2018, whereas as of September 2022, over 399,518 trials were registered. The clinical trials are expected to grow even further as the funding for research improves.

Gain deeper insights on the market and receive your free copy with TOC now @: Clinical Trial Investigative Site Network Market Report

This is expected to propel the growth of the industry post-pandemic. There is a growing focus on reducing the cost associated with clinical research. Hiring a clinical trial investigative site network supports the regulatory function, improves the enrollment of participants, assists in data management, and quality assurance. It increases process compliance, reduces process issues with each trial, and helps with faster trial initiations, and shorter trial timelines. These factors are supporting the demand for clinical investigative site networks. The governments are actively trying to improve R&D by providing tax deductions. For instance, in January 2022, the Indian government stated that it is providing a weighted average tax deduction of up to 200% in R&D.

Such initiatives are expected to improve the R&D activities on drugs and thus support industry growth. According to the IQVIA, report on oncology trends, clinical trials for cancer have been increasing for the last 10 years. For instance, in 2011, 1,242 trials were registered for cancer, and as of 2021, 2,335 trials were registered for cancer. The number of clinical trials for cancer is expected to rise even further owing to the growing prevalence of the disease. This is expected to improve the demand for clinical investigative site networks for cancer clinical trials post-pandemic.

[zenovelpharma]

Enhancing Clinical Studies with GCP Audit and Monitoring

Understanding GCP Audit and Monitoring

GCP guidelines set forth by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH) provide a framework to ensure the ethical conduct, safety, and quality of clinical trials. Audit and monitoring are essential components of GCP compliance and play a vital role in the success of clinical studies.

These processes involve the systematic review and verification of trial data, procedures, and processes to ensure compliance with GCP guidelines. It helps identify and rectify any deviations or discrepancies, guaranteeing the reliability and validity of trial results.

The Importance of GCP Audit and Monitoring

Data Integrity:

GCP audit and monitoring verify the accuracy and reliability of trial data, reducing the risk of errors or fraudulent practices. By maintaining high data integrity, researchers and regulatory bodies can have confidence in the trial results.

Participant Safety:

Ensuring GCP compliance helps safeguard the well-being and safety of trial participants. With thorough monitoring, potential risks and adverse events can be identified early, enabling prompt intervention

Early Detection of Issues:

Regular monitoring and audits help identify potential issues early on, allowing researchers to take corrective actions promptly. This proactive approach can prevent larger problems that may arise later in the trial.

Regulatory Compliance:

Trials that adhere to GCP guidelines are more likely to gain regulatory approval and acceptance, expediting the path to market for potential life-saving treatments.

Enhanced Trial Efficiency: 

Regular monitoring and audits improve the efficiency of clinical trials by identifying and addressing issues promptly. This minimizes costly delays and accelerates the overall trial timeline.

Zenovel's Contribution:

Zenovel offers a comprehensive GCP audit service that thoroughly examines all aspects of your clinical trial. Their team of experts meticulously assesses protocol adherence, data accuracy, informed consent processes, and investigator compliance.

By partnering with Zenovel, your trial gains an extra layer of assurance, knowing that any potential issues will be proactively addressed. Here are some key ways Zenovel has contributed to the advancement of clinical trials:

Experienced and Trained Professionals: 

Zenovel boasts a team of experienced and highly trained professionals with expertise in GCP guidelines and clinical trial monitoring. Their auditors and monitors possess a keen eye for detail, ensuring no aspect of the trial goes unnoticed.

Tailored Monitoring Strategies:

Recognizing that each clinical trial is unique, Zenovel devises customized monitoring strategies to suit the specific needs and complexity of each study. This approach optimizes resource utilization while maintaining the highest standards of quality

Real-time Oversight and Data Monitoring

GCP monitoring involves ongoing oversight of the trial’s progress and data collection to ensure accurate and reliable results. Monitoring activities identify and resolve data discrepancies, verify source data, and verify that the trial is being conducted in line with the approved protocol.

Early Identification of Risks and Mitigation Strategies

GCP audit and monitoring enable the early detection of potential risks and challenges during the trial. Identifying these issues promptly allows the trial sponsor and investigators to implement mitigation strategies, ensuring the study’s success and participant safety.

Enhanced Compliance with Regulatory Authorities

Adherence to GCP guidelines is crucial for obtaining regulatory approvals and ensuring acceptance of trial data by regulatory authorities. Non-compliance with GCP can lead to data rejection and delays in bringing life-saving treatments to patients.

Conclusion

In conclusion, GCP audit and monitoring significantly enhance the efficacy and reliability of clinical trials. By ensuring compliance with ethical standards, maintaining data accuracy, identifying risks early, and streamlining interactions with regulatory authorities, GCP audit and monitoring contribute immensely to the success of your clinical study.

Zenovel’s invaluable contribution to enhancing clinical studies lies in their comprehensive GCP audit and monitoring services. Their expertise and commitment to quality and compliance provide trial stakeholders with the confidence and tools needed to conduct safe and successful clinical trials.

When it comes to your clinical trial, don’t compromise on quality and compliance. Partner with Zenovel to unlock the full potential of your research and contribute to advancing medical science for the betterment of patients worldwide.

Adherence to GCP guidelines is crucial for obtaining regulatory approvals and ensuring acceptance of trial data by regulatory authorities. Non-compliance with GCP can lead to data rejection and delays in bringing life-saving treatments to patients.

[pineconepie]

How would Warren react to a reader that is not only mentally sick but also physically sick? Would he act the same or differently because reader has a chance of dying?

Good question! The answer is......not amazingly.

He'd act much different, surprisingly so. He'd insist on spending even more time with you, he'd use the straitjacket and padded room much less, and would lean more on protective than possessive.

Not only that, but he'd be pushing you to get all sorts of treatment, if possible. He's not a fan of the dangers that can come with clinical trials and experimental medicines, but the more desperate he gets, he'll push them on you and monitor your health extra closely.

I think you'd just slowly watch him become more erratic, day by day. He starts sleeping less, he snaps at almost anyone who isn't you, and mutters incoherently to himself.

You might even find him crying into his hands at your bedside, though depending on your state as well, he'll most likely deny it.

[lysatoru]

I’ll never smile again - Frank Sinatra

a little angst, reader is a neurosurgeon, neutral pronouns, ""friendship"", geto’s death is mentionned, cuss words, mention of death, mention of medical treatment, mention of graveyard

gojo satoru x reader

"time of death 10:34pm"

the monitor beeps. The noise is continuous and getting heavier and heavier to bear. You put down your scalpel, raise your hands and step away from the body. You look around, at a few people in the observatory, friends and journalists who’ve come to watch the first surgery about your experiment on a certain type of tumor, a new surgical approach to removing that tumor. A rather invasive approach indeed, but one that worked in clinical trials.

The intern begins to close the patient's skull. Drops of sweat begin to drip from your forehead, your vision starts to deteriorate more and more, you've got to get out of there. "I killed him, I killed him" goes round and round in your head. You smile slightly at the journalists in the observatory, including your best friend, your friends and Gojo. "I'm sorry, I have to go" you inform the other surgeons and doctors in the OR.

You leave the room quickly. Your best friend has seen the distress in your eyes, she knows you, she knows what you're like. "That's not a good sign" she murmurs before rubbing her face with both hands. Gojo looks at your best friend blankly and gets up, leaving the observatory. "Where are you going?" she asks Gojo "I won't be long" he replies.

You take off your coat, gloves and cap, throw the coat and gloves in the trash and your cap on the floor. You're trembling, suffocating, everyone was counting on you and you failed, you killed him. You needed air, you knew the journalists would be here as soon as possible. You walk into the x-ray room. You see them, the scans of your late patient, "what the hell happened?" you look at them over and over again. You go in circles in the room, biting your lip and rubbing your eyes. You rip the scans off the wall and throw them on the floor, "fuck!". Tears start to roll down your cheeks, unintentionally.

"Are you all right?" you hear a voice coming from behind you, you knew exactly who it was. Gojo slowly closes the door behind him and moves closer, "Everything's fine, everything's fine".

"Everything's fine?! Do you really think everything's fine?! Are you kidding me?!" you reply.

"Shh, it's not your fault you know" he tries to stay calm.

"Who operated on him? Who opened his skull? Who performed an invasive surgical method on him? It’s me!" you lose all control, gojo is not your enemy in this situation, quite the opposite. You move closer to him, pointing at yourself, tears flowing, your voice starting to break little by little

"You need to calm down, it was experimental and you know it" gojo puts his hands on your shoulders

"Do not touch me!" you reply, backing away violently.

He sighs and raises an eyebrow, leans back against a wall, crosses his arms and legs, "I'm not going to teach you your job, but death is part of your job. there are things you can't foresee".

"He was 15! He was 15 and he had a tumor since 13! He died at 15 because of me! It’s not fair!" you say crying your heart out . "Death was almost inevitable, you know that" he replies calmly.

"And what do you know about death? how often do you come into contact with it?" you approach him.

"What do you mean?" he approaches you too, clenches his jaw, the tension begins to build between you. "Don’t start with those things it won’t get us anywhere" he sighs once again. He didn't want to get upset because you'd just lost a patient who was very important to you, but he soon realized that the subject could take a rather dramatic turn.

"You dare lecture me about death and inevitability when you literally killed your best friend?"

— silence.

Gojo straightens up, uncrosses his arms and looks at you, raising his eyebrows, again "What did you say?"

"I'm sorry, I didn't mean to-" you’ve gone too far.

"Do you really think I wanted this? That I wanted all this?" he approaches you again, his eyes wide.

"I know I didn't, I'm sorry-" you slowly back away

"Do you really think that your job as a neurosurgeon, which you chose, and my job, which was imposed on me, are the same? Do you really think that I don't deal with death? You don't kill patients, you fail to save them, it's not the same. I kill people on purpose, that's the difference between us. — the more he talks, the closer he gets to you, you find yourself leaning against a wall involuntarily. You raise your head more and more to look at him because he's so tall — I have no choice but to do this job, you do. I kill those around me for ungrateful people like you"

"Satoru, please wait-" you start following him

The door slams and you find yourself alone in the scan room, you'd just pissed off the only person who'd come to support you after your defeat, Gojo considered you a true friend so much so that he confided about his friendship with Geto and how much he was suffering today, from his death. You knew that your patient's death and Geto's were incomparable, and yet you compared them. Why were you so stupid?

You start to follow gojo through the corridors but the journalists start to come between you "I'm sorry I have to-", "Did you make a mistake?", "why did he die?", "He was only 15, how do you feel?" fucking journalists. You see Gojo disappear in the hallway.

When you get home, you try to call Gojo, but he doesn't answer. You try to send him messages, but he doesn’t reply.

11:57pm

i’m sorry Satoru i know i fucked up

12:03pm

please, can we talk?

12:32pm

i think i know where you are, i’m coming

You get in your car and head down to the graveyard. A few minutes later you arrive in front of his grave and there he was, crouching, wearing his mask as usual, you've always wondered if it was also a way of hiding his emotions, the eyes speak, but his, what do they say ?

"Hi, you didn’t reply to my texts i was scared" you say softly. He doesn’t say anything. "I’m sorry you know i didn’t mean that" — "Why did you come ?" he say not looking at you but still looking at the grave. "I was worried". He laughs ironically "really ? you really are the last person i wanted to see here."

You decide to approach him a little. "I wanted to make sure you were fine" — "And I am, you can leave now"

You don’t know what to say anymore, it was all your fault anyway. "Satoru I-" — "leave" he looks at you and you decide to leave.

You know he’ll never smile the same again without Geto near him.

hi, first post since almost nine months *tries not to panick*. I don’t know how to feel about this, i think i lost the way i was writing before ? i don’t know. I have a feeling this is botch :( I wanted to try something new but anyway.

even though i’m not a big fan of this work, i’m really happy to writing again^^

if you think i use deepl for this one you’re right 😜👍🏻

[covid-safer-hotties]

Also preserved on our archive

A study reveals subtle, lasting cognitive impacts in healthy individuals following COVID-19 infection, highlighting the need for precise cognitive testing in future research.

A new analysis from Imperial College’s COVID-19 human challenge study has identified subtle changes in memory and cognition among healthy volunteers who were infected with SARS-CoV-2. These changes persisted for up to a year after infection.

Researchers noted that, despite the differences, all scores remained within the normal range for healthy individuals, and none of the participants reported lasting cognitive symptoms like brain fog.

Cognitive Impacts in Controlled Conditions The study, published in eClinical Medicine, found small but measurable differences in cognitive performance between 18 young, healthy participants who contracted the virus and those who did not, all monitored under carefully controlled conditions.

The team explains that incorporating such sensitive cognitive testing into future studies could help reveal more detailed insights into how infections may alter brain function and could help to find ways to reduce these processes when they cause symptoms.

Challenges and Methodologies Senior author Professor Adam Hampshire, from the Department of Brain Sciences at Imperial College London and now based at King’s College London, explained: “We know that COVID-19 can have lasting impacts on our memory and ability to carry out common cognitive tasks. However, much of the scientific evidence we have comes from large studies based on self-testing and reporting, or where there’s a range of variables that could increase or reduce these effects.

“Our work shows that these cognitive effects are replicated even under carefully controlled conditions in healthy individuals – including infection with a comparable dose of virus – and further highlights how respiratory infections can impact specific aspects of brain function.

“We were only able the detect some of these effects because of the trial design, which used very sensitive tests and controlled conditions, with participant performance compared to their own pre-inoculation baselines. This enabled us to pick up on subtle changes of which the participants themselves appear not to have been aware.”

COVID-19 and Cognition Previous studies that included patients with a wide range of severities have shown COVID-19 can have a lasting impact on people’s brain function. One such study, led by Imperial and involving more than 140,000 people, found small deficits in the performance of cognitive and memory tasks in people who had recovered from COVID-19, with differences evident a year or more after infection.

In the latest study, researchers analyzed findings from a small group of healthy volunteers who were part of the world’s first human challenge study for COVID-19 in 2021. The findings reveal subtle differences in how they performed on the same tests, which lasted up to 12 months although later testing could have been affected by other and later factors.

Human Challenge Study Design and Results During the trial, 36 healthy, young participants with no previous immunity to the virus were infected with SARS-CoV-2 and monitored under controlled clinical conditions. They were carefully monitored and remained at the facility until they were no longer infectious. From the group, 18 participants became infected and developed mild illness, one without symptoms.

Participants also performed sets of tasks to measure multiple distinct aspects of their brain function, including memory, planning, language, and problem-solving, using the Cognitron platform. Participants took the tests before exposure to the virus, during the two weeks they spent in the clinical facility, and then at multiple points for up to a year.

Analysis showed that those who became infected with SARS-CoV-2 had statistically lower cognitive scores than uninfected volunteers – compared to baseline scores – during their infection as well as during the follow-up period. The main differences in scores were seen in memory and executive function tasks (including working memory, attention, and problem-solving).

Lasting Impacts and Future Research Directions Differences in scores between groups were seen up to one year after infection, with the uninfected group performing slightly better on tasks overall.

The researchers note that the observed differences were small and that none of the volunteers reported prolonged cognitive symptoms. They also highlight limitations of the study, including the small sample size and that the majority of participants were white males, and so caution is needed in extrapolating the findings to the general population.

They explain that future research could examine the biological links between respiratory infection and cognition in COVID-19, and even show how this impact compares with other conditions, such as Respiratory syncytial virus (RSV) or influenza.

Co-author Professor Christopher Chiu, from the Department of Infectious Disease at Imperial College London, who led the COVID-19 human challenge study, said: “These latest findings from our study add more fine detail to the picture we have of COVID-19 and other respiratory infectious diseases.

“Challenge studies can offer a tool to help us better understand how infections disrupt a range of biological functions. Here, by showing biological effects that fall below what could be considered symptoms or disease, we were able to identify the smallest changes in these pathways. This could ultimately help us to develop new treatments to reduce or even block some of these effects, which we know in other settings can have lasting impacts on people’s lives.”

Reference: “Changes in memory and cognition during the SARS-CoV-2 human challenge study” by William Trender, Peter J. Hellyer, Ben Killingley, Mariya Kalinova, Alex J. Mann, Andrew P. Catchpole, David Menon, Edward Needham, Ryan Thwaites, Christopher Chiu, Gregory Scott and Adam Hampshire, 21 September 2024, eClinicalMedicine. DOI: 10.1016/j.eclinm.2024.102842 www.thelancet.com/journals/eclinm/article/PIIS2589-5370(24)00421-8/fulltext

This study was funded through the UK Vaccine Taskforce of the Department for Business, Energy and Industrial Strategy (BEIS).

The work was supported by the NIHR Imperial Biomedical Research Centre.

[malecardiolove]

The Test, Chapter 5

Jack remained strapped to the metal stretcher, his hands and feet bound, his chest exposed as the pink gas filled the room like a dense fog. Though his heart continued to resist, his mind fought to avoid succumbing to despair. The rapid beeping of the monitor beside him was the only sound breaking the silence, the only reminder that he was still alive—but not for long.

Dr. Ruiz’s voice filled the room once more, sharp and methodical as ever. "Your heart has endured more than I anticipated, Jack. I must admit, I’m impressed. But you know what this means, don’t you? You’re an anomaly. The goal has always been to find someone like you—a heart that not only survives but improves under pressure. But I’m not done yet."

Jack swallowed hard, the weight of the doctor’s words pressing down on him. He knew Ruiz wouldn’t stop, not as long as there was more to test. The certainty of what lay ahead paralyzed him with fear.

Suddenly, a low, menacing hum emanated from the machines around him. Jack felt the electrodes attached to his chest begin to vibrate, sending small jolts through his skin—not enough to harm him, but enough to remind him that he was entirely at the mercy of the system.

The echocardiogram monitor flickered slightly, showing that Jack’s heart was still responding to the stress, pumping with steady force. Yet, Ruiz wasn’t satisfied.

"This will be your final test," Ruiz announced, and a chill ran down Jack’s spine. "The pink gas has started to dissipate, but the real trial begins now."

The hum of the machines grew louder, and Jack felt a sudden, piercing cold in his chest. It wasn’t like the cooling tank from earlier; this was sharper, more invasive, as though something were reaching into his very heartbeat.

"I’ve modified the electrodes," Ruiz continued in a calculated tone. "Now, they’re designed to stimulate your heart directly—but not like a pacemaker. This time, I want to see how your heart responds to pain."

Jack’s eyes widened in horror as the first shock struck his chest. It wasn’t the sharp jolt of a defibrillator; it was slower, more controlled. The impact didn’t make him jump but pressed into him from within, as though his own heart was being forced to beat with brutal strength.

Jack screamed. His chest convulsed painfully as the electrodes delivered another shock, this one stronger. On the screen, his heart rate spiked wildly, his heartbeat growing erratic as it struggled to match the rhythm Ruiz demanded.

"The resilience of your heart is extraordinary, but… can it withstand prolonged pain?" Ruiz’s voice was clinically detached, yet Jack could detect the excitement beneath it.

The monitor’s beeping grew frenzied, each sound echoing Jack’s body’s desperate fight. He felt his pulse in every fiber of his being, the pain radiating from his chest to his limbs. The stretcher seemed to vibrate under the intensity of his heartbeats. Though his vision blurred, he could still make out the echocardiogram’s flashing numbers—alarming, yet not failing.

Ruiz didn’t stop.

The shocks came one after another, each more powerful than the last. Jack’s muscles tensed involuntarily with each impact. His heart, though large and resilient, began to show signs of strain. Its rhythm grew increasingly irregular, and Jack felt as if his chest might shatter from the overwhelming stimulation.

"Incredible, Jack. Your heart continues to beat despite everything. But this will be the ultimate test."

The hum of the machines reached its peak. Ruiz, observing through a glass barrier, watched with calculating eyes as he initiated the final phase of the trial. This time, the shocks became continuous, almost without pause. The pain was unbearable. Jack screamed, but his voice was drowned out by the echo of his own heartbeat pounding in his ears.

The echocardiogram monitor displayed numbers climbing into impossible ranges. Jack’s heart was on the brink of collapse, and he knew it. Each beat felt like a hammer blow, each breath an impossible effort.

And then, suddenly, everything stopped.

The beating. The sound. The pain.

The screen showed a flat line. His heart had stopped.

Ruiz stood silent for a moment, observing. Then, without urgency, he activated the emergency defibrillator, sending a shock directly to Jack’s chest. His body jerked violently on the stretcher, but there was no response.

A second shock. Still nothing.

Ruiz frowned slightly, then picked up a syringe containing a bright orange liquid. He carefully injected it directly into Jack’s heart through a long needle that pierced the center of his chest.

Slowly, the heartbeat returned. First, a faint thud, then another. The monitor came back to life. Against all odds, Jack’s heart continued to fight.

Ruiz smiled. "It seems you’ve survived once again. But this time, Jack…" His voice grew darker, more menacing. "It’s time to finish this."

The final chapter is coming...

[feminist-space]

"Today, December 20, marks the official end of the Marburg Virus Disease outbreak in Rwanda. It has been 42 days – two full incubation periods – since the last confirmed case left the national Marburg treatment centre after testing negative.

In previous outbreaks, Marburg, which is caused by a virus related to Ebola, has killed up to 88 per cent of people infected. And Rwanda had never seen this disease within its borders before the current outbreak began in September. Despite Rwandan physicians having never encountered it before, the mortality rate observed in this outbreak is under 23 per cent – the lowest-ever death rate for a Marburg outbreak in Africa.

While the virus initially spread fiercely in two major hospitals in the capital Kigali and among family members of one of the initial cases, Rwanda’s rapid response, with implementation of strict infection prevention and control, isolation and containment of cases, prompt initiation of aggressive supportive care, delivery of investigational therapeutics and vaccines, and tracing and monitoring of contacts quickly brought the outbreak under control. The rate of new cases halved between the outbreak’s second and third weeks and dropped by around 90 per cent thereafter.

One of the most remarkable aspects of this response was an international effort, initiated and led by the Rwandan government, to administer thousands of doses of a promising experimental vaccine to front-line health workers under a clinical trial protocol, with the first subjects vaccinated in a remarkably short timeframe.

...

Rwanda, for its part, has invested heavily in its healthcare system and has incorporated epidemic preparedness into its national health policies. Rwanda has well-trained medical staff working in well-run hospitals and community-based health services. It has been investing in technology-based disease surveillance systems and its laboratories can handle fast, accurate diagnostic testing at scale.

In early September, after months of planning, Rwandan scientists and health officials joined CEPI and other private sector partners to walk through a “tabletop exercise” about the 100 Days Mission. It was through this in-person training exercise that key relationships between disease outbreak experts, Rwandan health authorities and researchers, vaccine developers and clinical trial specialists were cemented.

...

We also have no doubt that with the right focus and funding, such nationally-led, globally-supported, life-saving responses to novel disease outbreaks could be accomplished by any government in any region. By taking a proactive approach and using the 100 Days Mission as a game plan, all countries can get ahead of epidemic and pandemic threats and neutralise their catastrophic potential."

Read the full piece here: https://www.telegraph.co.uk/global-health/science-and-disease/partnerships-preparedness-halted-rwanda-marburg-outbreak/

https://www.telegraph.co.uk/global-health/science-and-disease/partnerships-preparedness-halted-rwanda-marburg-outbreak/

[stillgotscars]

who else is still wondering how gemma came to be at lumon in the first place? we know she struggled to conceive, so was her desire for a child so deep, so all-encompassing, that she voluntarily faked her own death to be a part of lumon? in a state of desperation, did she sign herself away without understanding the disastrous ramifications? was she sold a false promise, agreeing to partake in some sort of project in exchange for fertility treatment, maybe? or was she “scouted” by lumon? when she went to the blood drive at the start of 2x07, the lumon logo was on the collection device. it stands to reason that they, consequently, had access to her DNA — so had they come across something that seemingly made her the “ideal” candidate for their experimental trials? additionally, lumon owns the fertility clinic she was attending. so did a doctor at the clinic (see: dr. mauer, given we not only saw him at the fertility clinic, but also monitoring gemma on the testing floor) work on gaining her trust, only to kidnap her when the opportunity cropped up — with the intent being to hold her hostage at lumon as a test subject indefinitely? it’s all just so devastating to think about.

[dovahhmonn]

The Voice in the Dream

Mouse/Dr.Easterman blurb below the cut + art 🎨

༉‧₊˚🕯️🖤❀༉‧₊˚.༉‧₊˚🕯️🖤❀༉‧₊˚.༉‧₊˚🕯️🖤❀༉‧₊˚.༉‧₊˚🕯️🖤❀

The dream was hazy, a murky expanse of shifting darkness and flickering light, like static dancing on an old television screen. Mouse stood in the middle of it, it was something that felt like neither floor nor air, her breath slow and steady as the world around her pulsed with an unseen rhythm.

And then, his voice.

Smooth, methodical, laced with the clinical warmth of a man who thought himself a savior.

"You're doing remarkably well, Mouse."

She turned, searching through the haze, but all she could make out was a tall, shadowy figure standing just beyond her reach. The outline of a man, indistinct, shifting like mist caught in the glow of a flickering bulb. She had never truly seen Dr. Easterman—only the still frames of his face on the cold, buzzing monitors. But his voice? His voice had followed her everywhere.

Through the radio in her dorm.

Through the speakers in the sleep room.

After every trial.

Always calling to her. Always watching.

"You're letting the therapy work," he continued, his voice dripping with approval. "Not fighting it. Accepting it. That's good, Mouse. Exceptional."

A shiver crawled down her spine.

Her hands, trembling yet desperate, reached out toward him. If she could just touch him, just feel something solid, something real—

But her fingers swiped through nothing.

The shadow unraveled beneath her touch, dispersing like smoke curling away from a dying ember.

Mouse's breath hitched. She tried again, reaching further, stretching her arm toward where she knew he was standing. But it was like trying to grasp fog, the figure slipping through her hands, never truly there.

"You're making such progress," he murmured, the words slipping through the air like a lullaby. "Listen to God, listen to my voice."

Her chest tightened. The darkness pulsed, closing in around her, swallowing the last traces of the figure standing before her.

And then—

Silence.

[stevishabitat]

Judge orders HHS, CDC and FDA to restore webpages and data : Shots - Health News : NPR

A federal judge has ordered federal health agencies to restore websites and datasets that were abruptly pulled down beginning in late January, prompting an outcry from medical and public health communities.

The temporary restraining order was granted in response to a lawsuit filed against the federal government by Doctors for America (DFA), a progressive advocacy group representing physicians, and the nonprofit Public Citizen, a consumer advocacy group.

Last week, a spokesperson for the Centers for Disease Control and Prevention told NPR "changes to the HHS website and HHS division websites are in accordance with President Trump's January 20 Executive Orders, Defending Women from Gender Ideology Extremism and Restoring Biological Truth to the Federal Government and Ending Radical And Wasteful Government DEI Programs And Preferencing."

The pages that are now set to be revived include information for patients about HIV testing and HIV prevention medication, guidance on contraceptives, datasets that show vulnerability to natural disasters and emergencies, and an action plan for improving enrollment of underrepresented populations in clinical trials.

Judge John Bates with the U.S. District Court for the District of Columbia, who was appointed by President George W. Bush in 2001, said the sudden loss of these resources had jeopardized the work of clinicians and public health. "It bears emphasizing who ultimately bears the harm of defendants' actions: everyday Americans, and most acutely, underprivileged Americans, seeking healthcare," he wrote in his opinion.

The Department of Health and Human Services, the Food and Drug Administration and the Centers for Disease Control and Prevention have until midnight Tuesday to bring back the specific webpages cited in the lawsuit.

By the end of the week, the order directs the federal government to identify any other resources that physicians rely on to provide medical care and restore those as well.

Questions remain about how much information was changed

"This is a very strong decision," said Dorit Reiss, a law professor at the University of California College of the Law San Francisco. The order explains how the takedown of websites and data was "likely legally flawed" because it "lacked notice" and there was "no explanation for the broad action," she said. "It suggests the government is in a weak place for this case."

HHS didn't reply to NPR's request for comment on the order.

Many webpages that were initially removed have since reappeared on CDC, FDA and HHS websites, although it's still unclear how much remains missing and what information has been modified.

"There's a lot of shifting ground here where they tore down a lot of stuff. They put some of it back up, but not nearly all of it," said Zach Shelley, an attorney with Public Citizen Litigation Group. "Hopefully with this order, we get everything that's important back up."

The sudden loss of websites prompted a mad rush in the scientific community to download and archive data. Dr. Joshua Sharfstein was among those on a CDC advisory committee who wrote the CDC's acting director protesting the purge of data.

He said the advisers have now sent a second letter pointing out that they remain concerned about "how communities will be able to monitor diseases and receive guidance on current disease investigations," the possibility of "broad workforce reductions," and "disruptions in grant funding."

The judge's order underscores any changes to resources and data should be based on "reasoned decision-making," said Sharfstein, a professor of public health practice at the Johns Hopkins Bloomberg School of Public Health.

"Some of these websites provided actual recommendations on how to take care of patients," he said. "These are not just like books on the shelf. These are like heavily thumbed through manuals that people really need."

[prof-dr-crane]

Clinical Observation: Trial One of Fear Toxin V-63

Objective:

The objective of this trial is to assess the efficacy of Fear Toxin V-63, a newly synthesized hallucinogenic compound designed to induce a sustained and malleable state of terror. The formula incorporates a refined alkaloid blend derived from Salvia divinorum, selected for its potent dissociative properties, alongside a neuroactive derivative of scopolamine to inhibit higher-order cognitive filtration. A volatile ketone compound facilitates rapid bloodstream absorption, while engineered quinazoline derivatives act on the amygdala’s β-adrenergic receptors to amplify fear recall and distort sensory input.

This iteration follows a series of failed batches, each promising in theory, yet disappointingly ineffective in practice. V-60 degraded too quickly in the bloodstream. V-61 caused neurological overstimulation, sending subjects into seizures before true terror could take hold. V-62 dulled perception rather than sharpening it, resulting in a lethargic, unresponsive state. Fear requires clarity, not sedation. V-63 is the first formula in some time that shows real potential.

Method:

A controlled administration of V-63 was conducted on a, somewhat, compliant subject. The compound, delivered via a calibrated aerosol, dispersed efficiently into the respiratory tract. Advanced biometric sensors and neural imaging were employed to monitor real-time physiological and neurological responses. Baseline metrics were recorded for heart rate, cortisol levels, and neural activity across regions implicated in fear response, notably the amygdala and insular cortex.

Observations:

- Onset of Reaction: Within 45 seconds post-administration, the subject displayed unmistakable signs of acute fear. A marked improvement from prior formulas, which often required a higher concentration or prolonged exposure.

- Physiological Response: A dramatic spike in heart rate was observed, accompanied by a surge in cortisol levels that exceeded previous baselines by approximately 17%. This is within the expected range for an authentic, unmitigated panic response.

- Neurological Activity: Imaging data revealed extensive activation in the amygdala and a pronounced response in the insular cortex and ventromedial prefrontal cortex, suggesting a widespread engagement of both primary and secondary emotional processing circuits. Encouraging.

- Behavioral Indicators: Hypervigilance, disorientation, intermittent verbal disintegration—abrupt gasps, fragmented sentences. The subject attempted to ground themselves in reality, but sensory distortions made this impossible. Most notable was the attempt to speak to something unseen. An improvement.

Conclusion:

V-63 has induced an effect distinct from its predecessors. This iteration does not merely force the subject to see their fears, it strips away the boundaries between fear and reality entirely. The mind no longer relives trauma but instead accepts terror as an inescapable truth. The hallucinations did not manifest as specters of the past, but as fully integrated intrusions into the present, impossible to rationalize or dismiss. Unlike previous formulas, which triggered reactive fear, V-63 appears to create a state of forced adaptation: A cognitive shift where fear is no longer a response, but the new baseline of existence.

The subject ceased attempts to fight or flee within three minutes. Not due to resignation, nor to physical exhaustion, but to the overwhelming certainty that escape was never an option to begin with. A breakthrough.

There is still work to be done. The duration must be extended, the sensory warping refined. But after a series of disappointments, this trial has proven what I have always known: fear is not a reflex. It is not a simple equation of stimulus and response. It is an environment, and at last, I am beginning to perfect it.

- Dr. Jonathan Crane