Around The Globe

India Perspective on Patient Engagement in Clinical Trials

Chirag Trivedi
Clinical Study Unit
Sanofi, India


eing in healthcare is a great opportunity to make a meaningful difference in the lives of patients by helping them to alleviate their suffering from disease and illnesses. Clinical Research has played a pivotal role in doing this.

Clinical research has come a long way in India, where communicable diseases are on the decline but non-communicable diseases are rising rapidly. Thus, it is important to conduct clinical trials in India to find newer treatment options for the diseases that affect Indian patients. While we constantly evolve and keep making ourselves better in designing, conducting, analyzing, and reporting clinical studies, one thing that has remained constant throughout is that the patient has been, and should always be, at the center of everything that we do in clinical research.

During the course of a clinical study, patient engagement plays a key role in retaining patients in the study. It is best to engage patients from the beginning. Increasingly, while designing clinical trials, sponsors around the world take inputs from patients and patient advocacy groups. This concept, though being practiced in many parts of the world, has yet to gain momentum in India, as very few patient advocacy groups exist in India today.

Specific activities that are oriented towards patient engagement are increasingly being used during clinical studies in India. Being sensitive to a patient’s needs and trying to lessen the inconveniences caused while participating in a clinical study have gone a long way towards keeping patients motivated. Due to the unique culture in India, the practices followed here sometimes differ from those followed in other countries.

The following are some of the current practices in India that are appreciated by patients participating in clinical trials:

  • The patients’ hospital visits are scheduled to their convenience. For example, study visits take place on Saturdays so that they don’t have to miss work.
  • Investigators and the study site team send personalized wishes on a patient’s birthday, wedding anniversary, etc.
  • Educational counselling/materials on living a healthy lifestyle, following a healthy diet, etc., are provided for both the patients and their families.
  • While keeping the cultural sensitivities in mind, it has helped to keep the families engaged. It is well known that in certain societies in India, a patient’s ecosystem, too, plays an important role in keeping the patients engaged and motivated.

In the current context of the evolving clinical trial scenario in India and with the heightened media sensitivity towards it there are some important aspects of patient engagement that should be kept in mind, and the following important questions need to be addressed:

  • How do Indian patients benefit from participating in clinical studies?
  • How can we bust the myth that Indian patients are being treated as “guinea pigs” in clinical trials and that our patients aren’t being exploited?
  • Are we doing enough to assure patients that their rights, safety, and well-being will always be protected while participating in a clinical trial?
  • Is there a lack of trust that we need to overcome?
  • How can we make the Indian patient see the greater good of clinical research, given that all currently available drugs have undergone the rigors of clinical trials?

These questions have to be addressed and answered convincingly by everyone involved in clinical research in India. Ethics and quality should always be considered to be of paramount importance.

Today, India has close to 17 percent of the world’s population and 20 percent of the global disease burden. Yet, less than 1.2 percent of the globally-registered clinical studies are conducted in India. There is a large unmet medical need for Indian patients. Thus, it is imperative for India that our patients see clinical research as an opportunity to advance our disease knowledge and to find newer and better treatment options.

Government, regulators, industry, healthcare professionals, media, and society need to work together to facilitate an ecosystem in which patients come forward to support drug development. In India, as it stands today, there still remains a lot of work to be done to achieve this goal. Clinical research helps us address the unmet medical needs of our patients. Therefore, engaging them at all stages will help us achieve this goal faster and better.