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Review
. 2015 Apr-Jun;6(2):82-5.
doi: 10.4103/2229-3485.154003.

Post-trial access to treatment for patients participating in clinical trials

Dinesh Chandra Doval  1 , Rashmi Shirali  1 , Rupal Sinha  2
Affiliations
Review

Post-trial access to treatment for patients participating in clinical trials

Dinesh Chandra Doval et al. Perspect Clin Res. 2015 Apr-Jun.

Abstract

Clinical trials are the mainstay for bringing out newer and better drugs to serve the mankind. By virtue of participating in a clinical trial, a patient receives access to the newer drugs/therapies, but nothing is generally being offered to them once their participation in the study comes to an end. Though the issue of post-trial access to treatment by patients participating in a clinical trial is debatable, there is no compelling justification either for or against it. We examined a case study in order to evaluate the applicability of post-trial access to treatment for patients participating in clinical trials. The provision of post-trial access to treatment should also keep into consideration the compassionate use of drugs on humanitarian grounds, especially in cases of trial drugs that have offered significant benefit to the trial patients and whose termination would lead to deterioration in patient's overall condition. In the present era of personalized medicine, the incorporation of genetic testing into clinical practice further authenticates the rationale of compassionate use of drugs and post-trial access to treatment.

Keywords: Clinical trials; medication; post-trial access.

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Conflict of interest statement

Conflict of Interest: None declared.

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