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Guidelines to be followed during clinical trial conduct

Posted by thsti on May 14th, 2020

Clinical trials need to be conducted on an ongoing basis because they form the base for the discovery of new drugs and treatment methods. As health services need to be critically robust and result-oriented with the larger purpose of improving the quality of life of patients, two things become extremely crucial –

  1. That clinical trials conducted are more; and
  2. That the trials are conducted ethically and as per best clinical practices with utmost priority to the safety of the patients or subjects.

All governments and regulatory authorities across the world keep introducing newer regulations from time to time to enforce certain key aspects. In India, recent changes in the clinical trial conduct guidelines emphasize that all trials need to be conducted as per the good clinical practices framed by the International Conference on Harmonization Guidelines (ICH-GCP).

Some of the key information of this guideline mentions that:

-          All human trials need to be preceded by animal trials and clinical trials have to be mandatorily undertaken to prove beyond doubt that a particular drug is going to give the desired results. Hence, before undertaking any human clinical trial, it is important that the objective, the issue, the benefit and the risks associated are all meticulously and ethically considered.

-          Clinical trial conduct covers four phases - Phase 1 is the clinical pharmacology trials where the drug is given to 2 healthy volunteers.; Phase II is the exploratory trials where the drug is given to 10 t0 12 volunteers spread over 3 to 4 centers; Phase III is the confirmatory trials where the patient base is increased to cover between 1000 to 3000 patients, and finally Phase IV or post-marketing phase where the reports are published for doctors who can then start to prescribe the drug to their patients.

-          The rights of the volunteers or informed patients need to be respected and protected at all cost. All associated risks need to be taken into account and the risk-benefit ratio evaluated thoroughly.

-          Following the Good Clinical Practice is compulsory where the rights and safety of patients are ensured. It also pertains to the proper data management plan clinical trial so that the confidentiality of patient data is ensured while the data used for the trial is reported with precision and ethically.

In the same convention, the guidelines pertaining to the accountabilities of the sponsors, investigators, and the ethics committee were also formulated and laid down for helping in the conduct of qualitative clinical trials.

Also See: Clinical Trials, Clinical Trial, Trials Where, Trial Conduct, Trials, Clinical, Trial

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