The world can't be this flat when it comes to clinical trial recruitment

I expected Patient Recruitment and Retention in India in the Drug Information Association Global Forum magazine to provide insights into the special factors confronting sponsors of clinical trials in India. India is a crucial place for drug development and since I’ve never been there (Thailand is the closest I’ve gotten) I don’t have firsthand experience. But if the author, Dr. Deepti Sanghavi, is correct, there seems to be essentially no difference between India and the US.

These are the barriers she cites:

  • Protocol-related barriers including tight inclusion/exclusion criteria, invasive procedures, frequent medical visits, use of placebos, shortage of patients for orphan indications
  • Disease-related barriers including the patient getting much better or worse and becomes less interested in the trial
  • Medicine-related barriers, such as the medicine tasting or smelling bad.
  • Investigator or site-related barrier such as competitive studies happening at the same site, lack of time or motivation to recruit, and poor communications or trust between doctor and patient.
  • Subject related barriers such as lack of awareness about clinical research, lack of awareness of disease status, age, social circumstances, inconvenient appointment times, lack of understanding of informed consent, and inadequate compensation.

Everything I read in the above applies equally to the US. The only India-specific points I saw in the article were:

  • Female subjects only participate after gaining consent of a male member of the family
  • There is less advertising than in the West
  • Lack of literacy is an issue

In any case I would have liked to read some more details about the barriers or at least have a couple of anecdotal examples. For instance:

  • Are there different ideas about bad tastes or smells that trip up Western sponsors in India, whose products don’t elicit objections at home?
  • How do typical inclusion/exclusion criteria affect the Indian population compared with those in the US or Western Europe?
  • How does India compare with other “alternative” places trials are done, such as Eastern Europe, China, and Brazil?
May 29, 2009

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