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Clinical Trials – all that you need to know, explained pointwise

What are Clinical Trials?

Clinical trials are research studies that explore whether a medical strategy, treatment, or device is safe and effective for humans. Before a drug  is launched in market, it has to be tested for its safety and efficacy. This is done in stages, with a large pool of patients after which the data from the trials is assessed.

Who is the regulator?

Central drug Standard Control Organisation – CDSCO. Regulates under Drugs and cosmetics Act.

Why is India a preferred destination for trials?

  • availability of large genetic pool with a wide spectrum of diseases
  • educated work force
  •  lower operational costs

What are the major issues ?

  • Regulatory failures
  • Unethical clinical trials
  • Spurious drugs
  • Collusion between drug companies and doctors

What has been done so far?

  • Registration of trials mandatory in the Clinical trials Registry.
  • Audio visual recording of informed consent in trials
  • CDSCO provided with power to inspect and suspend.
  • Drug Advisory Committees formed
  •  Ranjit Roy Choudhury Expert Committee constituted by the Union Health Ministry to formulate policy and guidelines for clinical trials recommends:-

1.  Clinical trials can only be carried out at centers which have been accredited for such purpose.

2. Ethics committee of the Institute must also be accredited.

  • SC principles to approve trials:

1.  Assessment of risk v/s benefit to patients

2.  Need for innovation along with existing therapeutic option

3.  Unmet medical needs in the country.

 

What should be the Ethical considerations?

  • Informed consent and Voluntary Agreement of the participant
  • Maintain privacy of the participant
  • Accountability and transparency while conducting trials
  • Research and trial details should be in public domain.

What is the way forward?

  • Compulsory registration of all clinical trials before any dosing starts. This will help in stopping illegal trials.
  • Suspending trials is not the solution as it will deprive people from accessing new drugs. Ethical imperative is that people who are injured directly because of participating in trials should be compensated and medically managed.
  • Safety of trial subjects is of paramount importance. Implementation of Ranjit Roy Committee recommendations may not be the ultimate solution to the problems plaguing the Clinical Trial Industry, but it would be a beginning for cleansing the Industry of unethical practices which puts the lives of our patient population at risk.

 

 

 

 

 

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