#clinical trial recruitment

[mprexhealthcare]

Navigating Challenges and Innovating Solutions in Clinical Trial Recruitment

Successfully navigating challenges in clinical trial recruitment is crucial for efficient clinical trial execution. Learn innovative solutions to optimize recruitment efforts and improve overall trial outcomes. Read now.

[clinical-trial-solutions]

eSource Solutions Provider | Clinical ink

Clinical ink eSource ecosystem is at the core of their clinical trial solutions, with the goal of integrating all incoming data into a uniform data platform that enables analytics inside & between studies. Their eSource solutions increase efficiency & reduce the cost of clinical trials, especially in complicated therapeutic areas. Contact them now!

[jeeva-trials]

Dealing with challenges in Quality Evidence Generation with a Real-Time Analytical Framework that makes Clinical Sense for Innovators

Evidence linking interventions with health outcomes is vital for healthcare decision-making. Making sound choices about healthcare requires the best possible and quality evidence from clinical research. However, some of the decisions currently made during the drug development process are not supported by high-quality evidence.  As such, making informed decisions for allocating adequate resources to guide clinical Research development becomes challenging. At mid-stage clinical development, the challenge entails in determining the specific indication, if there are multiple potential indications. Moreover, evidence that is complete for some individuals or groups may be incomplete for others, leading to inefficiencies in decision-making.

Evidence generation strategies are especially important at Phase III and Phase IV trials to allow for effective navigation through competitive and regulatory hurdles, while it may be difficult to effectively communicate potentially attractive product attributes to the stakeholders, especially when it has no clear advantage over comparators. Stakeholders also lack the evidence needed to make real-world decisions on approval, coverage and use of treatments as most current processes used in evidence generation focus narrowly on the safety and efficacy of treatment.

Datasets to inform real-time decision making

The traditional demarcation between pre- and post-approval phases does not fit many medical products, as regulatory decisions could be informed by the same evidence that informs the use and coverage decisions, though the criteria for decisions should not be the same for both cases. Validated tools, based on large datasets to help inform real-time decision making are invaluable, yet they are currently limited. When new treatments are approved, healthcare payers and those who participate in shared savings base coverage determination on their value which is calculated by the evidence of benefit and net costs. The incorporation of real-world data (RWD) and patient-reported outcomes (PRO) into the evidence generation process could assist in making coverage determinations by rendering clinical evidence and research more immediately translatable to the beneficiary population.

Real-world data (RWD) and real-world evidence (RWE)

Additionally, large differences usually exist between the evidence required for initial adopters, such as surveys and studies, and that required for most prospective randomized control trials (RCTs). While the healthcare community uses RWD and RWE to develop decision support tools for use in clinical practices, medical product developers use these data to support clinical trial designs and observational studies to generate innovative treatment approaches. FDA uses RWE and RWD to monitor adverse events, post-market safety of the drug, and to make regulatory decisions. While RWD can be collected from various sources such as electronic health records (EHRs) and product and disease registries, RWE can be generated by different study designs including observational studies and randomized trials.  

Aligning stakeholders for evidence generation

Aligning stakeholders is another big challenge of evidence generation as different stakeholders will have their own perspectives on uncertainties throughout the drug development lifecycle. Regulators may have different views as to what is acceptable to that of the patient. As such, it remains an industry-wide challenge to provide credible evidence for clinical research to innovators and investigators. Challenges exist for healthcare innovators to keep up to date with compliance and regulations about evidence generation as regulatory space evolves fast.

Because pharmaceutical companies tend to delegate evidence generation to individual departments that are often siloes, the process occurs sequentially, resulting in delays in crucial milestones such as getting regulatory approval before initiating an outcomes-based study.

https://www.futuremedicine.com/doi/10.2217/cer-2017-0073

An analytical framework model that makes clinical sense

There is a pressing need for high-quality evidence generation as regulators and payers seek more long-term data on product safety and effectiveness. As such, more efficient methodologies for generating evidence are required for decision-making, and to enhance clinical evidence collection and interpretation. An analytical framework model makes clinical sense as an evidentiary pathway, however, the challenge for investigators in evidence gathering is to fill out the framework. If the study design is weak, then the link in the evidence chain is also weak. Studies need to be carefully and prospectively designed, and opportunities exist to add well-designed studies into current practices. Study teams and researchers should consider how to most effectively translate diagnostic tests into practice needs within clinical settings.

Quality clinical evidence of safety and efficacy

The Jeeva™ eClinical Cloud platform provides clinical decision-makers with a modular and integrated approach to evidence planning and generation. From a single dashboard, study leaders can monitor data in real time to track safety and efficacy in representative patient populations across vast distances. The Jeeva™ eClinical Cloud is designed for efficient, remote long-term follow-up, natural history and other observational studies as well as interventional clinical trials regardless of therapeutic area. Jeeva™ enables quality clinical evidence generation to evaluate treatment safety and efficacy and tracks patients’ adherence to medications, in compliance with regulatory agencies such as Institutional Review Boards, EMA, FDA, and GDPR.

Digital-first approach to evidence generation

Study teams, innovators, drug developers, biopharmaceutical sponsors, clinical researchers, hospital sites and contract research organizations (CROs) face challenges to overcome the “no evidence, no implementation—no implementation, no evidence” paradox. Jeeva™ provides a new, digital-first, patient-centric approach to evidence generation that considers patients as partners for clinical trials, not merely subjects.  

The Jeeva™ eClinical Cloud is user-designed software-as-a-service (SaaS) platform that allows volunteers to conveniently complete clinical trials wherever they are. The flexible and modular bring-your-own-device (BYOD) solution works on any browser-enabled mobile device and cuts out 70% of logistical burdens for study teams and patients. The modular and flexible Software as a Service (SaaS) subscription-based model is enriched with many features such as automated enrollment workflows, electronic patient-reported outcomes, 2-way email and SMS communication, uploading of lab reports, and more that are designed to encourage innovators to undertake research activities, rather than be intimidated by the complexity, logistical burdens, duration and costs of the traditional evidence generation approaches.

Quickly setup clinical studies of any scale or duration

Jeeva™ applies an innovative approach to remote screening, eConsent, patient registries and natural history studies can enable the generation of higher-quality, low-cost and more timely evidence generation for clinical trials. Jeeva™ offers a cost-effective solution to quickly set up and conduct clinical studies, of any scale or duration, with or without patient travel involved (e.g. hybrid or fully decentralized clinical trial protocols). Jeeva™ provides a more effective clinical trial design in terms of evidence generation, accelerating patient recruitment, site feasibility and endpoints that bring unmatched efficiencies in terms of the quality of evidence, time, and costs.

[leapcure]

Understanding POTS – Symptoms, Causes, and Management

Learn about Postural Orthostatic Tachycardia Syndrome (POTS) with Leapcure. Discover its symptoms, causes, effective management strategies, and explore Postural Orthostatic Tachycardia Syndrome clinical trials for cutting-edge treatments

[kitsaai]

https://kitsa.ai/team/

[theconcinnitycompany]

5 Ways CROs can Improve Their Clinical Trial Manager Recruitment Efforts

As the clinical trial industry continues to expand in this post-COVID environment, Contract Research Organizations (CROs) need to hire more clinical trial managers to ensure the success of their studies. An experienced clinical trial manager can differentiate between a successful and unsuccessful trial. As such, they are integral to the success of a CRO’s operations. In this post, we’re sharing five ways that CROs can improve their clinical trial manager recruitment efforts. 

[creativeera]

Clinical Trials Support Services: Enabling Medical Advancements through Quality Research

Types of Clinical Trials Support Services Clinical trial support encompasses a wide array of services required to conduct medical research efficiently and effectively. Some of the key types of support services include: Regulatory Support

Clinical trials must adhere to stringent regulations and standards to ensure safety and ethical conduct. Regulatory support services help navigate these requirements and secure necessary approvals. Regulatory experts aid with preparation of documents such as clinical trial applications and maintaining compliance throughout the trial lifecycle. Patient Recruitment Support

Finding suitable human volunteers is one of the biggest challenges in clinical research. Dedicated patient recruitment teams leverage different online and offline strategies to promote awareness of trials and screen potential candidates as per eligibility criteria. Their efforts are vital for timely patient enrollment and study completion. Site Management Support

Managing the operational aspects at Clinical Trials Support Services sites spread across locations requires dedicated coordination. Site management services take care of site initiation activities, training investigators and staff, addressing their queries, facilitating logistics and ensuring protocol adherence. This helps sites function efficiently and focus on participant care. Biostatistics and Data Management Support

Clinical trials generate huge volumes of data at each stage that needs to be captured, assessed and reported as per quality standards. Biostatisticians and clinical data managers employ their analytical skills and use specialized software to plan the data collection methodology, perform interim analyses, and compile the clinical study report. Medical Writing Support

From drafting patient consent forms and recruitment material to compiling clinical study reports – medical writing plays a significant role in clearly communicating critical information for different stakeholders. Experienced medical writers utilize their medical and regulatory expertise to develop high-quality documentation tailored to the audience. Safety Monitoring and Pharmacovigilance

Ensuring participant safety is the utmost priority in clinical research. Independent safety boards and pharmacovigilance teams closely monitor trials for any adverse events. They analyze trends, determine causality and take necessary actions to minimize risks to human subjects. Logistics Support

Timely shipment of investigational products, medical supplies and equipment to sites spread across multiple countries requires efficient logistics management. Logistics coordinators arrange for customized solutions like GPS-enabled transportation, proper storage facilities and distribution tracking systems. Advantages of Outsourcing Clinical Trial Support Services With the complexity of modern clinical trials, most pharmaceutical and biotech organizations leverage specialized clinical research organizations (CROs) to outsource support functions: Access to Expertise

CROs employ multidisciplinary teams of highly qualified clinical research experts with vast international experience. Their combined and focused skillsets can deliver superior services than an in-house function. Cost Savings

Outsourcing non-core operations frees up internal resources for other strategic activities. It also offers scalability with pay-as-you-go fee-for-service models to match financing needs at each stage. This provides significant cost advantages over building in-house infrastructure. Infrastructure and Technology

CROs make large investments in state-of-the-art technologies, facilities and resources required to support global clinical trials. Outsourcing leverages these resources that would otherwise require high capital expenditure for sponsors. Resource Flexibility

CRO staffing can easily scale up or down based on changing study requirements without long-term commitments. This flexibility enables sponsors to focus on core development work while managing variable external support needs. Compliance Expertise

With experience spanning hundreds of trials globally, CROs have in-depth knowledge and polished processes to ensure compliance with regulations in different regions. This mitigates risks of non-compliance for sponsors. Conducting Large Multinational Trials

Some clinical programs involve complex trials across dozens of countries simultaneously. Few sponsors have the bandwidth to internally coordinate such large-scale global operations. CROs specialize in seamlessly executing multinational clinical programs. Quality Clinical Trial Support Services Define Clinical Research Success A few key aspects guarantee the delivery of high-quality clinical trial support services: Extensive Therapeutic Experience

CROs with proven track record of supporting various therapeutic areas can adeptly cater to specific sponsor requirements and anticipate challenges through their past learning. Robust Quality Management Systems

Adopting global quality standards like GCP, ISO certified processes and ongoing audits ensure consistent adherence to protocol, timely issue resolution and generation of reliable data. Technology Integrated Solutions

Leveraging customized applications for functions like patient recruitment, site payments, interactive drug supply chain tracking and integrated clinical data capture enhances efficiency. Prequalified Global Network

A pre-established pool of qualified clinical sites, laboratories and investigators across regions facilitates rapid study startup. Their pre-qualification saves time in site feasibility assessments. Proactive Communication Culture

Regular sponsor interactions, performance reporting and swift issue escalation enable identifying risks early and collaborative troubleshooting. This drives seamless collaboration. Clinical Trials Support Services Talent Development Focus

Ongoing training and skill development programs for both sponsor and CRO staff keep the clinical research talent abreast with evolving science and best practices to deliver best quality.

Get more insights on Clinical Trials Support Services

Priya Pandey is a dynamic and passionate editor with over three years of expertise in content editing and proofreading. Holding a bachelor's degree in biotechnology, Priya has a knack for making the content engaging. Her diverse portfolio includes editing documents across different industries, including food and beverages, information and technology, healthcare, chemical and materials, etc. Priya's meticulous attention to detail and commitment to excellence make her an invaluable asset in the world of content creation and refinement.

(LinkedIn- https://www.linkedin.com/in/priya-pandey-8417a8173/)

[medtack]

Clinical Trial Patient Recruitment

MedTack provides an advanced clinical trial recruitment platform. Our innovative solutions streamline the recruitment process, connecting researchers with eligible participants efficiently. Explore MedTack for a reliable platform that accelerates clinical trial recruitment.

[market-insider]

Clinical Trials : Holistic Exploration of the Current State and Future Outlook

The global clinical trials market size is expected to reach USD 123.5 billion by 2030, expanding at a CAGR of 6.49 from 2024 to 2030, according to a new report by Grand View Research, Inc. An increase in the volume and complexity of clinical trials has been witnessed lately, which plays an important role in the R&D of new drugs and products. The market witnessed a decline of 6% in 2020 owing to the COVID-19 pandemic. However, the market is projected to recover from 2021 onwards. In addition, clinical trials have become increasingly costly, adding to the overall cost of developing a drug.

Clinical Trials Market Report Highlights

The phase III clinical trials segment dominated the market with a 53.3% share in 2023. This can be attributed to the complexity of this phase

The interventional studies segment dominated the market in 2023. It is one of the most prominent methods used in clinical trials in the study design segment owing to the increasing demand for the intervention for clinical trials by researchers

North America held 50.3% of the market share in 2023. Favorable government initiatives and the presence of a large number of players in the U.S. that offer advanced services are responsible for market growth

Asia Pacific region is anticipated to grow at the fastest CAGR over the forecast period owing to the increasing patient pool and cost-efficient services.

For More Details or Sample Copy please visit link @: Clinical Trials Market Report

The increasing need for developing new drugs for chronic diseases, such as cancer, respiratory disorders, diabetes, cardiovascular diseases, and others, is creating immense pressure on the healthcare industry. The COVID-19 pandemic and the increasing demand for developing a suitable treatment are driving the market. The high number of people affected by the disease further depicts an increasing need for therapeutics & vaccines. Currently, there are 288 therapeutics and 106 vaccines under development, out of which, nearly 7.0% of therapeutics are in Phase IV, 21.0% in Phase III, and 43.0% & 13.0% in Phase II & Phase I, respectively.

The pandemic has resulted in the global disruption of traditional onsite clinical trials. Hence, regulatory bodies worldwide have undertaken various initiatives for fast-tracking clinical trials for the development of innovative solutions. One such instance is Solidarity, an international clinical trial launched by the WHO to find effective treatment against COVID-19. Although the pandemic has forced many medical device & drug developers to revise the approach to such crises, integrating best practices within clinical trial procedures & adapting to virtual trials, which can support the continuous development of therapeutics.

ClinicalTrials #HealthcareResearch #MedicalInnovation #DrugDevelopment #PatientRecruitment #Biopharmaceuticals #ClinicalResearch #RegulatoryCompliance #DataManagement #PatientEngagement #PrecisionMedicine #TherapeuticTrials #CROs #ClinicalResearchOrganizations #GlobalHealth #ClinicalStudyDesign #PharmaceuticalIndustry #BiotechResearch #ClinicalEndpoints #HealthTechIntegration

[neolytica]

Neolytica - Transforming HCP Segmentation, Engagement, and Targeting

Discover the power of Neolytica's innovative software solutions for HCP Segmentation, Engagement, and Targeting. Unleash the potential of KOL Mapping, Health Care Mapping, and Patient Recruitment for clinical trials. Revolutionize your healthcare marketing strategy today.

[root-analysis]

Clinical Trial Patient Recruitment Market Report | Market Size | 2035

The clinical trial patient recruitment software market is estimated to be worth $0.69 billion in 2022 and is expected to grow at a compounded annual growth rate (CAGR) of 14% during the forecast period. The study presents an in-depth analysis, highlighting the capabilities of various stakeholders engaged in this domain. Click here to get a detailed insights report now!

[clinical-trial-solutions]

Remote Solutions to Improve Patient Engagement | Clinical Ink

At Clinical ink, they’re committed to researching & implementing solutions for improved patient recruitment & retention using digital technology. Visit the blog now to learn more!

[procth]

Current Challenges in Clinical Trial Patient Recruitment and Enrollment

Clinical trials are an essential part of the drug development process. They help ensure the safety and efficacy of new medications before they are approved for public use. However, patient recruitment and enrollment in clinical trials can be a significant challenge for researchers and study sponsors. In this article, we will explore some of the current challenges in clinical trial patient recruitment and enrollment and discuss potential solutions.

One of the most significant challenges in clinical trial patient recruitment and enrollment is finding suitable patients to participate. Many clinical trials have strict inclusion and exclusion criteria that limit the pool of eligible participants. This can be particularly challenging for rare diseases or conditions that affect a small population. In these cases, researchers may need to expand their search to multiple sites or even international locations to find enough eligible patients.

Another challenge is the lack of diversity in clinical trial participants. Historically, clinical trials have predominantly included white males, which can limit the generalizability of study results to other populations. This lack of diversity can also be a barrier to patient recruitment and enrollment, as individuals from underrepresented populations may be hesitant to participate in clinical trials due to mistrust of the medical establishment or concerns about the potential risks and benefits.

Additionally, patient recruitment and enrollment can be time-consuming and costly. Study sponsors may need to use multiple recruitment methods, such as advertising, social media outreach, and physician referrals, to find eligible participants. These methods can be expensive and may not always result in a sufficient number of participants. Furthermore, the lengthy process of identifying and screening potential participants can delay the start of the study and increase study costs.

To address these challenges, researchers and study sponsors can consider several potential solutions. One approach is to expand the pool of eligible participants by relaxing some of the inclusion and exclusion criteria. For example, researchers could consider including patients with comorbidities or other medical conditions that may have previously excluded them from the study. This approach could increase the number of eligible participants and improve the generalizability of study results.

Another solution is to improve outreach and engagement with underrepresented populations. This could involve partnering with community organizations or patient advocacy groups to build trust and raise awareness of clinical trials. Researchers could also consider providing education and resources to potential participants to address concerns and dispel misconceptions about clinical trials.

Technology can also play a role in improving patient recruitment and enrollment. For example, researchers could use electronic health records to identify potential participants who meet the study's inclusion criteria. Additionally, social media and digital advertising could be used to reach a broader audience and engage potential participants.

In conclusion, patient recruitment and enrollment are critical components of clinical trials, but they can also present significant challenges for researchers and study sponsors. To address these challenges, researchers can consider expanding the pool of eligible participants, improving outreach and engagement with underrepresented populations, and leveraging technology to improve recruitment methods. By addressing these challenges, we can improve the efficiency and effectiveness of clinical trials and ultimately improve patient care.

[leapcure]

Understanding Idiopathic Pulmonary Fibrosis – Causes and Treatments

Learn about idiopathic pulmonary fibrosis with Leapcure. Discover its causes, symptoms, and the current treatment options available, including Idiopathic Pulmonary Fibrosis clinical trials, to manage this lung disease.

[kitsaai]

https://kitsa.ai/team/