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

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....

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Detalles Bibliográficos
Autores principales: Doval, Dinesh Chandra, Shirali, Rashmi, Sinha, Rupal
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Medknow Publications & Media Pvt Ltd 2015
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4394585/
https://www.ncbi.nlm.nih.gov/pubmed/25878952
http://dx.doi.org/10.4103/2229-3485.154003
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author Doval, Dinesh Chandra
Shirali, Rashmi
Sinha, Rupal
author_facet Doval, Dinesh Chandra
Shirali, Rashmi
Sinha, Rupal
author_sort Doval, Dinesh Chandra
collection PubMed
description 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.
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spelling pubmed-43945852015-04-15 Post-trial access to treatment for patients participating in clinical trials Doval, Dinesh Chandra Shirali, Rashmi Sinha, Rupal Perspect Clin Res Review Article 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. Medknow Publications & Media Pvt Ltd 2015 /pmc/articles/PMC4394585/ /pubmed/25878952 http://dx.doi.org/10.4103/2229-3485.154003 Text en Copyright: © Perspectives in Clinical Research http://creativecommons.org/licenses/by-nc-sa/3.0 This is an open-access article distributed under the terms of the Creative Commons Attribution-Noncommercial-Share Alike 3.0 Unported, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
spellingShingle Review Article
Doval, Dinesh Chandra
Shirali, Rashmi
Sinha, Rupal
Post-trial access to treatment for patients participating in clinical trials
title Post-trial access to treatment for patients participating in clinical trials
title_full Post-trial access to treatment for patients participating in clinical trials
title_fullStr Post-trial access to treatment for patients participating in clinical trials
title_full_unstemmed Post-trial access to treatment for patients participating in clinical trials
title_short Post-trial access to treatment for patients participating in clinical trials
title_sort post-trial access to treatment for patients participating in clinical trials
topic Review Article
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC4394585/
https://www.ncbi.nlm.nih.gov/pubmed/25878952
http://dx.doi.org/10.4103/2229-3485.154003
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