Identification and Recruitment of Human Subjects for Trials – Challenges & Mitigation
Identification and recruitment of human subjects as per the inclusion and exclusion criteria is a crucial step in clinical trials.
Participant Identifications are intensely analyzed via Sources such as social media, Advertisements, Surveys, Electronic Health Records (EHR). Now a days, technologies can scrutinize social media content to identify specific regions where a condition is more prevalent, thus narrowing down the search for the right cohort. EHR provides a vast and vital data of subject to detect patient subgroups that might benefit more in a clinical trial.
Recruitment of subjects must be equitable, and factors appropriate to the condition that is studied. All recruitment efforts must respect personal rights to privacy and confidentiality and avoid compulsion or undue influence of subjects.
Three essential areas to strategize the recruitment planning are,
(1) Trial design and Protocol development,
(2) Trial feasibility and Site selection, and
(3) Communication
Any challenge in this process can affect all the stakeholders involved. The following five are the key challenges in this recruitment phase of the trials,
1. Subject’s Reluctancy to Use Technology: Digital technologies have been well developed in clinical trials. Lack of training of the advanced technologies and inadequate level of communication will risk the involvement of participants in trials.
Strategies to Mitigate: Educating participants will provide them a better understanding of clinical trial process and technologies. Maintaining regular connect with subjects will make them feel more secure and facilitate trust relationship with clinical study staffs.
2. Lack of Feasibility - Clinical trials that require multiple levels of follow-ups with a complex structure are unlikely to attract participants. The lack of feasibility for the human subjects to participate can be a potential barrier to their recruitment.
Strategies to Mitigate: We need to educate them about the study's length, complexity, and relevance. Also, the feasibility must be well-studied before drafting the protocols.
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3. Lack of information and incentives - Quite often, there is a lack of clear information about the overall conduct of the study. In Addition, there is a lack of incentives for participants to enter the study.
Strategies to Mitigate: Instead of neglecting this issue, we need to recognize it and reduce the burden on the participant by providing them adequate incentives (monetary or others).
4. Challenges from Expert Subjects– Another constraint while recruiting for trials is the participation of subjects who professionally enrol in the study for monetary incentives and other similar reasons. Such participants can significantly affect the integrity of the trials with skewed results.
Strategies to Mitigate: Instead of blindly excluding such possibilities, we need to screen participants through telephone, surveys and clinical data registries before enrolment.
5. Socio-Cultural challenges: Subjects may also refrain from recruitment into potentially beneficial trials due to the prevailing socio-cultural barriers. Negative stigma about diseases or treatment modalities and negative media publications about some studies can prevent participants from joining the study.
Strategies to Mitigate: Instead of brushing away such socio-cultural factors, we should carefully consider them. We need to gain the participants' confidence before enrolling them on the study.
In conclusion, we need to holistically understand the participant's concerns before considering them to be part of the clinical study and recruiting them. This process will avoid any future challenges with participant retention, follow-ups and the overall outcome of the study.
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