Open AccessPost-trial access to treatment for patients participating in clinical trials
Author(s) -
Dinesh Chandra Doval,
Рашми Ширали,
Rajesh Kumar Sinha
Publication year - 2015
Publication title -
perspectives in clinical research
Language(s) - English
Resource type - Journals
SCImago Journal Rank - 0.649
H-Index - 8
eISSN - 2229-5488
pISSN - 2229-3485
DOI - 10.4103/2229-3485.154003
Subject(s) - clinical trial , compassionate use , medicine , alternative medicine , nothing , intensive care medicine , pathology , philosophy , epistemology
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.