Over the last 15 years, the field of clinical trials (CT) grew when multinational pharma companies included Indian hospitals sites in global CT, as there was potential for fast recruitment of treatment naïve Indian patients. However, the majority of such patients treated at public hospitals were poor and had low literacy levels. Concerns about exploitation of socioeconomically disadvantaged patients in CT created a backlash, causing the government to strengthen regulations to protect CT participants. But the challenges of inclusion of socioeconomically underprivileged patients in CT are unending and merit thorough consideration from the perspective of the autonomy of the participants, and an assessment of benefits and risks.
Autonomy means respect for the patient’s choices and decisions. This means the patient has a right to evaluate benefits and risks, and decide whether to take part in a CT.
Participation in a CT gives a patient the direct benefit of receiving a new expensive therapy, which may be effective for a serious / incurable condition like cancer or multi-drug resistant TB. There are also indirect benefits – better supervised medical care, direct access to physician-investigator, free medical management of inter-current illnesses and reimbursement of travel expenses for follow-up visits etc.
The risks include serious adverse reactions such as injury or death, the inconvenience of investigations – lab, imaging, biopsy, frequent follow-ups etc. But the real risk is whether 1) the patient has understood the experimental nature of the CT, or there is a therapeutic misconception, with the patient believing that the aim of CT is to administer treatment rather than to conduct research.
These patients are vulnerable, as informed consent (IC) to participate in a CT may be unduly influenced by the expectation of receiving benefits, or concerns about the consequences of refusal to participate in a trial. Competence to informed consent means the ability to understand and evaluate relevant information, make a rational decision without undue influence and convey consent or refusal to participate in a trial. As the socioeconomically disadvantaged are likely to be less competent in protecting their own interests, it is essential that others should be responsible for protecting their interests.
The clinical researcher should justify the need for research in this vulnerable population, take steps to minimize the risks, provide additional safeguards, and invest time and effort in the consent process to explain the risks/inconveniences to the patient and/or her legal representative in her language without resorting to coercion or offering undue inducements.
The ethics committee should ensure that the investigator has considered and established adequate human protection measures before initiation, during the conduct and after the completion of the CT. The ethics committee should monitor the CT to ensure that additional safeguards, e.g., voluntary IC, audio-visual recording of IC process, free medical management and compensation for serious adverse events, compensation for travel, ancillary care for non-research-related conditions or incidental findings and post-trial access to new therapy or standard therapy, are available to patients.
As Indian pharma industry is developing research-based new drugs, the inclusion of socioeconomically disadvantaged participants in clinical trials is unavoidable. However, this requirement can only be justified if such vulnerable patients are empowered, and their autonomy, rights, safety and wellbeing are protected.
Writer is a consultant on clinical research & development from Mumbai. firstname.lastname@example.org