Hindrance and Possible Solutions of Conducting a Clinical Trial

A Student’s Perspective

Postgraduation in the medical career has become inevitable nowadays. In India, pursuing a postgraduation seat in any Institute of National Importance (INI) (which are claimed as the premier public higher education institution in India by an act of Parliament of India[¹]) has been a dream for many undergraduates because of the superior academic activities, research experience, patient exposure, and not but not least the pride and a handsome stipend associated with them. Nevertheless, the struggle does not end with getting a seat, and actually, the real struggle begins when one joins the postgraduation course. However, research is often underrated and not given much importance during their undergraduation period. Very few students have exposure to the basics of research during their undergraduate times with the help of the Indian Council for Medical Research, Short Term Studentship (ICMR-STS) program, conducted annually.[²]

After joining postgraduation in any INI, the postgraduate (PG) students spend the initial days acclimatizing to the new place and familiarizing themselves with the routine activities of their concerned department. Usually, students have considerable exposure to academic activities and patient care during their undergraduate period, and there is relatively less exposure to research activities. The deadline for submitting the protocol for their dissertation soon arrives, and the students become overburdened with the thoughts of preparing it among their routine activities.

Another major problem faced by the PG trainees is the language and/or cultural barrier. A person opting for a seat in any INI, which has distinguished cultural, regional, and food differences from his native place, is quite challenging to cope with. However, few institutes run a short-term language training program to facilitate the students who are not native to their language.[³] Establishing a regional language department in every INI will be very helpful to the students. They also help in translating official documents of any research activity (e.g., case record form). Mostly, the topic of the dissertation solely depends upon the guide to whom the student gets allotted. Also, choosing a clinical trial for a thesis dissertation is usually the least considered due to several challenges like a financial burden, trained workforce, expertise in research methodology, and time constraints. In general, the thesis protocol submission will be roughly within 3 months of joining, and the PGs are supposed to work on their thesis along with their routine duties. To ease this, students must undergo a workshop on research methodology or watch lectures and videos on a standard portal such as Swayam.[⁴] Allotment of a guide to the PG trainee should be done as early as possible, and it helps in establishing the rapport between the guide and the PG trainee so that they can easily discuss the research area of interest and other prospects of the study that has to be undertaken.

If any study involves human, animal, or community (survey-like study) participants, the PG student experiences a considerable amount of anxiety and apprehension. The anxiety and apprehension can be easily sorted out by prior sensitization of the trainee to the new workplace. A formal introduction to the concerned department members and explaining their work schedule can ease the process. This process also generates a rapport and enables the smooth conduction of the study.

Recruitment of patients in the study needs expertise indeed. The recruitment process should be transparent without violating ethics. The recruitment process is very tedious, and patients often tend to refuse the investigator for various reasons, like, lack of patience after waiting for long hours to meet the clinician and various false information about the clinical trials circulated in the media. However, a group of patients also accept participating in the study because of the free treatment and personal attention. A dedicated room must be allocated to every outpatient department (OPD)/inpatient department (IPD) with basic amenities like a computer, printer, and good internet connection for a smooth recruitment process and trial-related activities. It will be helpful for effective communication with patients without disturbing other patients. A short and comprehensive video clip narrating the study process can be displayed in the room. The video should contain the details about the study in the local language in written format, and the video should not have any audio. Pamphlets or newspaper ads can also be issued with prior approval from the Institute Ethics Committee (IEC).

A facilitator for research activities can be appointed for every institute. Candidates working in these posts will be helpful in assisting researchers in many aspects. They can help in follow-ups, guiding the participants, especially the elderly population, in reaching various parts of the hospital premises based on investigational purposes or expert opinion from other physicians. The facilitator’s role will be beneficial in exceptional circumstances, e.g., coronavirus disease 2019 (COVID-19) infection of the principal investigator or any other trial members.

In a few INIs, the outpatient department’s patient inflow is well maintained by prior registration. Patients have to get their online registration for getting an appointment in the concerned department, and most of the time, it is difficult due to the limited number of seats. These difficulties hinder the patient from actively participating in any clinical trial with multiple follow-ups. To tackle this issue, a dedicated counter for OPD registration and sample collection should be made for patients concerned with research activity. The study participants can also be given special attention by prioritizing their requirements.

The investigator can make a separate identifier (seal/tag) for the study participants, which depicts the date of enrolment and the end of the study. Patients with such a seal should be provided registration at any time point during the study period. The role of funding is crucial as the charges for participant’s investigations can be waived off and drugs are provided for the trial period. It will not create any financial burden on the patients. Patients tend to ask for interventional drugs more than the study period if they significantly improve with the drug. A transparent explanation of the study details at the time of recruitment will reduce these problems. However, the unused drugs due to other patients’ loss to follow-up or termination from the trial due to any adverse drug reaction can be utilized for the other patients who need the drug.

Another major obstacle is the follow-up in the clinical trial. Both the patients and the investigator have difficulty remembering the follow-up dates. The trial investigator can set alarms in their mobile calendar to ensure regular follow-up. The patient refuses to come for follow-up as they have to travel frequently and again face the problem of registration and long waiting hours to meet the physician, and their expenses for traveling were also unmet. If the study involves elderly patients or children, their follow-up is solely based on their caretaker or family member as they usually need travel assistance. Free nutritious meals/snacks can be provided to patients and this will be more beneficial for the patients who require fasting blood samples.

Academic studies are the foundation of a country’s clinical research strength. The results of these trials are purely intended for academic purposes and not for commercial or promotional purposes.[⁵] Students should be encouraged to do clinical trials for their dissertations despite the shortcomings discussed above. Every expert was once a beginner, and every beginner can lighten a new arena in the academic clinical trial.

Financial support and sponsorship

Nil.

Conflicts of interest

There are no conflicts of interest.