Patient recruitmentis widely recognized as a key determinant of successful clinical trials. Recruitment challenges persist, despite multiple efforts over decades to identify and address the barriers.
Clinical research is a study to evaluate the effects of one or more health related interventions on human participants. Clinical research is classified as, observational study, investigators observe the participants to determine the outcome; and interventional study, investigators give the subjects an intervention to compare the treated subjects with those receiving no treatment or a standard treatment.These experiments or studiesconducted inclinical research are called Clinical trials.
Testing a drug or intervention to determine the dosage, efficacy and safety is the main aim of clinical trials. Investigators initially conduct smallpilot studies and subsequently enrol patients for large-scale comparative studies, depending on the type of study and product. Each clinical trial has a unique set of protocols, rationales for conducting the research and diverse stakeholders.
Factors affecting Patient recruitment
Clinical trialsare performed to collect medical and scientific data regarding the efficacy and safety of a new intervention in patients. Thus, patient recruitment is crucial for clinical trials. The multistep process of patient recruitment for a clinical trial is complex. The impact of patient recruitment on overall efforts to effectively diagnose, treat or prevent disease has resulted in exploring multiple determinants affecting the recruitment process. It requires identifying eligible patients, understanding the study concept and recognising the risks or benefits of the study. Enhancing recruitment and retention is possible by giving greater consideration to participant convenience, providing participant incentives, compensation for participation and financial support to recruiters. Policies employed and resources available at the clinical trial site are other factors influencing recruitment process.
Failures in meeting recruitment goals have financial, scientific and ethical implications, thereby demoralizing efforts of investigators, participants, and sponsors. Researchers have examined trial design, identified issues of the staff, considered recruitment strategies, modified timeline and revised recruitment targets to achieve recruitment success. Upstream planning may be the best target in the life cycle of a clinical trial for positively influencing downstream recruitment outcomes.
Patient recruitment planning
The aim of recruitment planning is to encourage sponsors, investigators and patients to actively seek solutions and overcome challenges in patient recruitment. Patient recruitment can be improved by recruitment planning recommendations intrial design, protocol development, trial feasibility, site selection and recruitment communication. Organizing protocol design, site selection and overall communication can have positive impact on recruitment planning. The project team needs to address the issues related to participant retention and formulate ways of maintaining the recruits. The use and development of recruitment planning framework could help improve retention of the participants. Upstream approach to recruitment planning has the potential to reduce downstream barriers.
Recruitment involves an active engagement of multiple stakeholders in designing the protocols and recommendations that are then adopted and implemented by all stakeholders. Incorporating inputs of stakeholders is vital for developing more comprehensive and strategic recruitment recommendations. There are tools available for adoption and implementation of such recommendations. These tools can address decision-making by stakeholders, monitoring recruitment performance and acknowledging outcomes reported in patients. Also, the use of integrated data driven recruitment tools can avoid delays.
Recruitment framework and recommendations will serve as a guide for clinical trial recruitment planning, irrespective of the disease or intervention under study. Enrolment can be more accurate and precise through site level recruitment and clinical development based on density of target population. Clinical trials can be more successful with higherpatient retentionratesthrough specific strategies of patient engagement, increase in the number of patients per site and use of specialized recruitment resources. Precise online targeting is a cost-effective strategy to locate interested patients. There is a need to increase awareness of clinical trials and its benefits, inform patients of local opportunities and offer patients with support resources to increase their comfort level with clinical trials. All this can make trial recruitment more efficient and predictable.
Online Course in Clinical Research
James Lind Institute (JLI) provides an online programs in Clinical Research, Pharmacovigilance and Medical Writing that can provides an extensive understanding of the clinical trial enterprise for making a successful career in clinical research and its allied fields like, pharmacovigilance, medical writing and data management.
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