International Journal of Applied and Basic Medical Research

REVIEW ARTICLE
Year
: 2019  |  Volume : 9  |  Issue : 1  |  Page : 3--8

Posttrial access to medical interventions: Intricacies, challenges, and solutions


Harmanjit Singh1, Sunil Vishwas Rao2, Ashish Kumar Kakkar3, Jagjit Singh1, Hasitha Diana Manohar2 
1 Department of Pharmacology, Government Medical College and Hospital, Chandigarh, India
2 Department of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research Center, Kanchipuram, Tamil Nadu, India
3 Department of Pharmacology, Postgraduate Institute of Medical Education and Research, Chandigarh, India

Correspondence Address:
Dr. Hasitha Diana Manohar
Department of Pharmacology, Karpaga Vinayaga Institute of Medical Sciences and Research Center, Madurantagam, Kanchipuram, Tamil Nadu
India

With the recent increase in clinical trials, lower- and middle-income countries are preferred trial sites due to lower budgets and easy availability of potential participants. On trial completion, benefits to participants cease and it may affect their health adversely. Therefore, entitlement to posttrial access (PTA) of interventions is imperative. The Declaration of Helsinki and several other guidelines mandate that trial participants have access to experimentally proven efficacious drugs and that the research protocol should mention PTA provision mechanisms. A controversial question about PTA is whether, experimentally proven therapy should be made accessible to the control group as well as the community from which the participants were enrolled, especially if no satisfactory standard treatment exists. PTA has significant implications for various stakeholders – trial participants, investigators, sponsors, regulatory authorities, and governments and has been discussed and well addressed in recent guidelines issued by the Indian Council of Medical research. This article focuses on the PTA, guidelines related to PTA, disputes, different stakeholder perspectives, and practical difficulties in its implementation. It also looks at PTA from the Indian perspective and considers possible solutions to deal with the controversies.


How to cite this article:
Singh H, Rao SV, Kakkar AK, Singh J, Manohar HD. Posttrial access to medical interventions: Intricacies, challenges, and solutions.Int J App Basic Med Res 2019;9:3-8


How to cite this URL:
Singh H, Rao SV, Kakkar AK, Singh J, Manohar HD. Posttrial access to medical interventions: Intricacies, challenges, and solutions. Int J App Basic Med Res [serial online] 2019 [cited 2019 Nov 18 ];9:3-8
Available from: http://www.ijabmr.org/article.asp?issn=2229-516X;year=2019;volume=9;issue=1;spage=3;epage=8;aulast=Singh;type=0