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Clinical trials EDITORIAL DECODE 4 JAN, 2018

Clinical trials EDITORIAL DECODE 4 JAN, 2018

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What are clinical trials?

  • Clinical trials are experiments or observations done in clinical research. Such prospective biomedical or behavioral research studies on human participants are designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison.

What is the bias against india in clinical trials?

  • It is shameful that India harbours a significant quantum of major illnesses that are not seen in other parts of the world.
  • In the recent Global Burden of Disease study published in Lancet, India ranked 154th out of 195 countries as far as access to healthcare and quality are concerned.
  • Despite there being a large number of patients with varied conditions in the country, most clinical trials, unfortunately, still focus on ailments thay have a western bias to their origin or numbers.
  • The number of trials on indigenous innovative methodologies in the diagnosis, treatment and surveillance of disease typical to the Indian subcontinent are very few.
  • Most of such indigenous trials are either poorly conceived and hence dropped at the evaluation stage or are copies of ongoing trials in some other parts of the world.

Balanced view

  • Clinical trials are here to stay. It is important that such trials are better regulated with the patient or the subject at the center stage of all policy considerations in this respect.
  • Safeguarding the interests of the patient in a clinical trial is as holy as the grail. Scientific advancement and patient safety are two sides of the same coin.
  • We must realise that we cannot have one at the cost of the other.
  • Adequate regulations which safeguard patient interests and ease the conduct of clinical trials will go a long way in establishing a “culture” of clinical trials in this country.



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