February 20, 2025
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Recruitment of patients for clinical trials: the importance of thinking about the patient from the start
Recruiting patients to participate in clinical trials can be a complex and costly process for clinical research promoters. However, considering their needs, emotional situation, scientific understanding, and many other factors is key to achieving high participation from the outset of the research.
By Sermes Cro
Patient recruitment for clinical trials is one of the most crucial and, at the same time, most complex aspects of clinical research. Without patients, there is no trial, but the real key lies in recognizing that patients are not just subjects of study; they represent the core reason for clinical trials’ existence: the advancement of medicine to improve human health. In this context, the difficulty in recruiting and retaining suitable participants is one of the main barriers that can compromise both the viability and quality of the research.
An effective and differentiating strategy to improve patient recruitment and retention rates is to adopt a patient-centered approach from the early stages of clinical trial development, particularly during the protocol design phase. This approach not only facilitates recruitment but also optimizes the quality of the data collected and promotes sustained patient engagement throughout the study.
Thinking About the Patient from Protocol Design
From the moment a clinical trial is planned, it is essential to consider comprehensively the patient’s needs, attempt to analyze the situation from their perspective, and assess what concerns them the most when participating in a clinical trial. The protocol design should be accessible, understandable, and as inclusive as possible to represent the widest possible range of people. According to a report from The National Institutes of Health (NIH), an inclusive and humanized protocol not only increases the diversity of the sample but also ensures that the results are more representative of the general population (NIH, 2021).
Using clear and simple language is critical to ensure that potential patients understand both the objectives and the possible benefits of the trial. Technical jargon or overly complex language can create a significant distance with patients who do not have a medical or scientific background. According to the National Cancer Institute’s Patient Recruitment Best Practices Report (2022), patients are more likely to participate in trials when the information provided is understandable and transparent.
Furthermore, reviewing and evaluating inclusion and exclusion criteria is essential to avoid unnecessary restrictions that limit diverse patient access to the trial. In many cases, overly strict patient selection criteria can exclude groups that could benefit from the research, reducing the representativeness and applicability of the results. Through an inclusive approach, the number of participants is increased, which in turn enhances the generalization of the results.
The Journal of Clinical Trials (2023) also highlights that flexibility in inclusion and exclusion criteria, as well as a better understanding of patients’ living conditions (such as work, family care, geographic accessibility, etc.), improve patient retention during the trial.
Humanizing the Protocol and Transparent Communication
Beyond the technical design, humanizing the trial protocol means recognizing and addressing patients’ emotional and psychological concerns. Clear communication about the risks, benefits, procedures, and expectations of the trial is crucial to fostering an atmosphere of trust. According to a study by The Lancet (2022), transparency regarding the risks and benefits of the trial can increase patients’ willingness to participate and adhere to the protocol, thereby contributing to higher retention rates.
Maintaining an open line of communication throughout all stages of the trial, from enrollment to completion, helps resolve doubts and issues efficiently, ensuring that patients feel supported at all times. Additionally, as experts from CureSearch for Children’s Cancer (2023) suggest, active and personalized follow-up can minimize uncertainty, increasing ongoing participation.
Benefits of a Patient-Centered Approach
Adopting a patient-centered approach in the clinical trial design phase not only improves recruitment rates but also optimizes the quality and relevance of the data obtained. The main benefits a patient-centered approach provides are as follows:
- Higher Recruitment Rate: Studies indicate that patients are more likely to participate in trials designed with their needs and circumstances in mind. A report from Pharmaceutical Research (2021) concluded that trials employing inclusive and personalized strategies are up to 30% more successful in recruiting participants than those that do not.
- Improve Patient Retention: Retaining patients is one of the biggest challenges in clinical trials. According to the National Institute of Health and Care Excellence (NICE) (2022), patients who feel valued, well-informed, and supported are much more likely to complete the trial. Additionally, creating a consistent support network throughout the trial, such as personalized guidance, helps significantly reduce dropout rates.
- Higher Quality Data: A study from JAMA Network Open (2022) concluded that a patient-centered approach improves the accuracy and relevance of the data obtained, as involved patients are more engaged and motivated to follow the protocol and report any side effects or health changes honestly.
Recruiting patients for clinical trials is a complex process that must be carefully managed from the early stages of protocol development. Thinking about the patient from the design phase not only simplifies the recruitment process but also improves the quality of the data obtained and the retention of participants throughout the trial.
Adopting a patient-centered approach is, ultimately, key to improving the results of clinical trials and, ultimately, offering more effective and personalized solutions to patients.
Sources
- National Institutes of Health (NIH), “Considerations in the Design of Inclusive Clinical Trials“, 2021.
- National Cancer Institute, “Patient Recruitment Best Practices Report“, 2022.
- Journal of Clinical Trials, “Evaluation of Inclusion Criteria in Clinical Trials“, 2023.
- The Lancet, “Impact of Transparent Communication on Patient Participation in Clinical Trials“, 2022.
- CureSearch for Children’s Cancer, “How to Increase Patient Retention in Pediatric Clinical Trials“, 2023.
- Pharmaceutical Research, “Success in Patient Recruitment for Clinical Trials“, 2021.
- National Institute of Health and Care Excellence (NICE), “Best Practices for Patient Retention in Clinical Trials“, 2022.
- JAMA Network Open, “Effects of a Patient-Centered Approach on Clinical Trial Data“, 2022.
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