Reasons for participation

There are number of reasons that lead an individual to participate in CTs. A few of the CT participants stated that they participated in CTs as they perceived their participation as benefitting others. This was seen in patients suffering from cancer especially.

“I had some hope that this drug might help me and help others like me” (CT participant, Maharashtra).

A combination of push and pull factors motivates participation in CTs which are explained below.

Economic reasons are one of the most compelling push factors to enroll in CTs even in the presence of alternative treatment.

“I did not think about it much. I knew that I could never have afforded the injection. So I decided to be part of the study. I did not have any idea about such studies till I heard about them. In my case, I was told that the injection would help me and that it was free” (CT participant, Gujarat).

KIs opined that educated urban patients with financial means are often reluctant to be part of CT with majority of participants belonging to rural areas with limited financial means.

Free medicines and free investigations

“Free treatment” is one of the strongest pull factors influencing trial participation. Even though a participant could afford the current treatment, availability of free treatment can still attract patients to get enrolled.

Access to “new treatment”

Access to “new treatment” is also another source of motivation for participation in CTs. Some of the CT subjects enrolled in CTs because their treatment at the time was perceived as not being effective or not working very well for them and they were hopeful about the drugs being tried. This perception was magnified by its reinforcement by doctors.

Trust in the doctor/influence of the doctor-patient relationship

Another strong pull factor is the doctor's influence on patient decision with regard to participation in the CT. This influence emanates largely from the hierarchical relationship between doctors and patients as well the trust that is largely reposed in the doctor's judgment with regard to latter's health. Trust is an essential, yet complex component of the CT dynamics. Participants narrated that doctor's “assurance” about the “new treatment” and it being the best option available to them played an important role in allaying their apprehensions about the experimental nature of the treatment being offered. Another matter of significance is the dual role of the caregiver as the investigator of a CT where patients feel obliged to take part in the trial perceiving a continuum of care by their doctor, which may not be available if they decline to be part of the trial. Hence, it is essential that an independent doctor not previously treating the patient attends to the CT participant and gives honest and complete information about the CT.

“The doctor told me that the fat levels in my blood are high due to some infection in my arteries. He suggested a new improved and free treatment that I could consider. I thought that there was no harm in trying a new treatment since I anyway trusted the doctor.” (CT participant, Maharashtra).