1. Growing clinical research
2021 saw around 1415 Ayurvedic interventional clinical trials registered on the CTRI website, which increased to 1268 in 2022, all COVID-19-related. Currently, the various institutes in Maharashtra have 934 trials in progress, amongst which Pune is home to 95 Ayurvedic interventional trials [1]. Having said that, is the general population aware of these ongoing studies? If not, how do researchers hope to recruit participants? People are informed about clinical trials via local newspapers, brochures, through the internet and media, or in-person interaction at a carefully selected handful of places.
2. Social perceptions and participation
There are numerous reasons why people do or don’t volunteer for clinical trials. People want free body check-ups, access to the newest treatment, reimbursement for their time, some to take benefit of the medical care that is being provided over the due course, and barely a handful want to contribute to science. Another aspect of voluntary participation is how the study’s details are communicated and who does this. People are keen if information is conveyed by a medical practitioner or senior professor; interest varies if it’s a young research fellow or student. Creating awareness about scientific research on a routine day in a busy person’s life is hugely ignored under the pretense of workload. Communication skills play an important role; capturing the attention of participants and conveying an accurate and trustworthy message within a few minutes is difficult. It requires being able to answer questions that people might ask while being spoken to about the study, a sound understanding of the study, and speaking about it in an appropriate way, following some of the principles of ethics. Now, it’s a given that a study design must ensure that the 12 basic principles of ethics are followed, but these are not limited to the study design [2]. They are to be followed in letters and spirit in every activity starting from conceptualization to reporting the study outcomes. These principles also play an important role when convincing participants to volunteer. Every researcher while deciphering the study (let’s consider an ayurvedic interventional trial, for instance) to an individual in the general population and convincing the participant to be a part of their study involves abiding by almost the 10 principles of ethics: essentiality, non-exploitation, voluntariness, social responsibility, privacy and confidentiality, risk minimization, professional competence, maximization of benefits, transparency and accountability, totality and responsibility.
It is important to note that the Indian people’s perspectives are likely to be influenced by societal attitudes and the environment they grew up in. Approaching female participants for an interventional trial that lasts a couple of months can give the researchers new insight into the population’s mindset. Most women deny participation on the grounds of having to seek permission from spouses or families, some are homemakers who must focus on caring for children because they are too small, few deny a visit to the study site, and prefer staying home to monitor their children’s schedule since they are in the 10th/12th class while others can’t travel to the study site because there isn’t anyone to drop/pick them. Men, on the other hand, inquire if they would have to stop smoking or consuming alcohol, some might consider participation only if the intervention (IP) is dispensed at home, others refuse to be a part of a double-blind trial since they are not interested in consuming a placebo. There’s also still a good number of people who do not trust ayurvedic interventions and their efficacy.
Working individuals interested in participation have their own set of restrictions. Some people cannot spare the time from their schedule for the screening process and can only come while randomization, some are free only on Sundays, others being paid daily wages can’t afford to take the time off. A few interested individuals have co-morbidities, thus inhibiting participation. Not just this, but people in science also hesitate to be a part of a clinical trial. Post-doctoral fellows, doctors, and scientific researchers themselves refuse participation in such studies. Ground realities and challenges like these lead to further deviations causing study delay, affecting the final outcome. Participant recruitment can be a major challenge for clinical trials if people start rejecting the interventional design outright.