As discussed this week, clinical trials are important for class 2 and 3 devices. They also require significant planning, communication, and overview. The CITI training for clinical researchers warns about the dangers of selecting trial participants in regards to protected characteristics, providing informed consent, minimizing harm, etc. However, in many studies I've read, unless the clinical trials call for a specific age group or demographic (such as pregnant women or elderly patients), they often include cis, white, male, college-age participants at a disproportional rate, which can skew trial results by making them only tested/technically valid for a specific people group. Of course, college students can be easily recruited due to their proximity to a large number of labs and willigness to participate for a monetary reward, but college students may be at more of a physical prime than middle-aged adults, or for studies that involve dietary practices, sleep, or other psychological factors, may be under unique stressors. When looking to plan clinical trials, how can you try to ethically involve more people groups (age, gender, physicality, etc)? How can you reach and motivate adults to participate if they are not experiencing the medical issue themselves and would in theory find out about the trial via the hospital/their doctors?
Incorporating diverse sites in a clinical trial that are not the major academic hospitals, as you mentioned, would be one of the best ways to involve more groups of people. This would require greater leverage and outreach by trial members to educate potential participants and build their trust. Eliminating barriers that would prevent participants from enrolling, such as transportation or scheduling conflicts, should be considered. Regarding the project, the clinical trial initiation phase should adequately cover the study design and scope. Defining the product's indications and the claims to be proven should determine the types of study groups. The initiation phase also considers the costs of all these measures, whereas the planning phase balances them against resources and time. Broadening the study groups in the clinical trial contributes to a higher-quality study that regulatory bodies are more likely to accept.
One additional approach could be using decentralized or hybrid clinical trials, where some parts of the study (like follow-ups or monitoring) are done remotely. This can make participation easier for people who live far from major hospitals or have time constraints. Another idea is culturally tailored recruitment, where materials and communication are adapted to better reflect different communities. Involving community leaders or patient advocates could also help build trust and improve participation. Finally, trials could use adaptive enrollment strategies, where recruitment is adjusted in real time to ensure more balanced representation across different groups.
I think this is a very prevalent issue that is often overlooked in studies! There was one study in particular that I saw that measured an individuals happiness based on subjective surveys and was conducted entirely with white cis males who attended Harvard. I think the best way to diversify the population of a study is implement targets for certain demographics or groups to ensure that the group is diverse enough. This can be done by recruiting a large number of participants and narrowing down the eligible subjects by the desired study sample size while ensuring there is diversity amongst the selected cohort. I have also seen studies motivate adults to sign up by providing the participants with therapies or treatments for their ailments. In this way both the researchers and study subjects benefit, and the subjects receive an incentive to sign on without it falling under coercion. Lastly, allowing subjects to participate in a study from their home or remotely can also allow more individuals to participate. Of course, this is not feasible for all studies, but can be made possible through the use of online meetings (telehealth meetings) and wearable monitoring equipment.