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Why are patient recruitment and retention important for clinical trials?
A clinical study’s purpose is to answer a research question. To do so, researchers must recruit appropriate participants and retain as many as possible for the period specified in the protocol.
If recruitment or retention is insufficient, a study may not achieve its objective, researchers may not be able to answer the question, and recruited participants may have been put at unwarranted risk. Therefore, participant recruitment and retention are critical to the success of any clinical study.
Most clinical study participants are currently recruited in the following ways:
- Patients already receiving treatment at a research site are asked to consider enrolling in appropriate studies.
- Referred by Other Professionals.
- People interested in participating in a study will respond to newspaper advertisements, flyers, and ads on social media, the web, radio, or television.
While these strategies are effective, recruitment and retention are challenges that require a well-designed plan. In this series, we will look at specific challenges in recruiting and retaining study participants and explore practical and effective strategies to overcome them. In addition, we will look at how the digitalization of clinical trials is transforming this field, providing new opportunities to improve the efficiency and success of studies. In this first part, we will address recruitment and, in the second, retention of participants in clinical trials.
Important Considerations Impacting Recruitment of Participants for a Clinical Trial
- Purpose of the Study: The purpose of a study will define its appropriate participant population.
- Generalizability of results: Adequate numbers of participants are essential so that study results can be generalized.
- Equity: Participants should be chosen for reasons related to the studied problem and not simply because of their availability or vulnerability.
- Adequate representation of women and minorities: These groups must be adequately represented so that research findings are meaningful and beneficial to them.
- Protection of vulnerable participants: In general, participants from vulnerable populations should only be enrolled in studies that relate to their circumstances. However, these groups should be protected from being excluded from participating in research.
- Reasonable inclusion and exclusion criteria: Strict inclusion and exclusion criteria can make recruiting adequate study participants difficult.
Challenges of Recruiting Patients in Clinical Trials
Population heterogeneity: Identifying and recruiting patients with specific characteristics is a constant challenge. Diversity in terms of age, gender, medical conditions, and genetic background requires tailored approaches.
Competition between studies: With multiple studies competing for the same patient groups, making a clinical trial stand out to a sponsor is challenging. Differentiation can make the difference between success and failure in recruitment.
Distrust of clinical trials: Many people still distrust clinical trials due to psychological and cultural barriers. Overcoming this distrust is essential to attracting more participants.
Elements of a successful recruitment strategy
If regulation permits, develop a compensation strategy that adequately reimburses participants for their time and expenses without coercion.
Ensure you budget for initial training, advertising, staff time, and other expenses.
Develop a profile of potential study participants.
Review previous studies’ recruitment rates, dropout rates, and screening success rates, incorporating lessons learned.
Choose appropriate staff members to conduct recruitment.
Monitor the number of participants enrolled per recruiter per site.
Monitor recruitment carefully and intervene quickly to change recruitment techniques that prove unsuccessful.
Identify barriers to recruitment.
Proven and effective strategies for recruiting patients in clinical trials
Population segmentation: Analyzing demographic and medical data to identify and reach the most relevant segments can significantly increase recruitment rates.
Collaboration with patient organizations: Establishing solid relationships with these organizations can facilitate access to patient groups and build trust in the study.
Communication with clinical trial participants: Use digital tools and social media platforms to increase the study’s visibility and reach a broader audience. It is essential to identify eligible participants correctly. Use electronic medical records, patient databases, and digital media to identify potential participants who meet the study’s inclusion criteria.
Cultivate potential sources of referrals for the study, network with site staff who are not working on the study, and meet with other local physicians and health professionals.
Send direct mail to selected health professionals.
Participate in health fairs, talks, support groups, radio interviews, television, social media, and other forums.
Request public service announcements on radio and television.
Studies can also use websites to recruit and evaluate participants. However, it is important to emphasize that the ethics committee must approve all recruitment strategies beforehand.
Technology in Recruitment and Retention of Patients in Clinical Trials
Technology in Clinical Trials
Visibility of information: The recruitment team has an advantage over other teams by building complete, updated, and securely stored patient databases.
Follow-up: Detailed follow-up, education strategies, referral management, and complete information on each patient facilitate the progress of the recruitment process.
Recruitment platforms: A CRM system like the one in the image below is very useful (Trial360). It has functions such as creating stages and qualifying opportunities, which help prioritize and focus efforts. A platform allows for more efficient recruitment process management, facilitating the identification and selection of suitable patients.
Recommended Reading: 6 Benefits of Automating Recruitment Flow in Clinical Trials
Artificial Intelligence: AI is being used to streamline patient selection by improving the accuracy and efficiency of the process.
Conclusion
Patient recruitment and retention in clinical trials are critical challenges that must be addressed with detailed planning, commitment to adequate resources, careful follow-up for timely identification and resolution of issues, and incorporation of innovative technologies. Proper population segmentation, collaboration with patient organizations, and using digital tools can make a big difference. Digitalization of clinical trials promises to significantly improve the efficiency and success of these studies, paving the way for crucial medical advances.
Stay tuned for our next post on specific strategies for retaining participants in clinical trials.
