Sama’s New Relaeases

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Sama Resource Group for women and Health in collaboration with Bern Declaration (BD), a Switzerland based NGO carried out to a Study to explore the conduct of clinical trials sponsored by Swiss pharmaceutical companies in India. The main objective is to verify if these companies comply with the relevant ethical standards and with the regulatory environment in India from the perspective of various constituencies and stakeholders. The study was conducted across four states of India and 17 clinical trial participants were interviewed.  The study focused on informed consent, sourcing and recruitment of participants and the issues related to compensation vis-à-vis clinical trials. 

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

 

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This multi-site study was conducted by Sama during 2011-2013 exploring the perspectives of the clinical trial participants with regards to various aspects of clinical trials. The study was conducted across 37 institutions located in seven cities from four states of India. During the study, total 67 interviews were conducted which included 36 clinical trial participants and 31 other key informants. This study examined the perspectives of the clinical trial participants with respect to the various components of the clinical trials such as recruitment, reasons for participation, informed consent, adverse events, compensation and post trial access. In the process of recruitment, various pathways through which the participants reach the clinical trial have been explored along with the most common places for recruitment of the participants. 

The study elaborates various push and pull factors such as economic status, free health services, trust on the doctor etc. which influence the decision of participant of enrolling in the clinical trial. Informed consent has been discussed in its conceptual paradigm in detail dealing with comprehension of the information in consent form and voluntariness of the consent. The issues related to adverse events and compensation including the recent regulatory developments in the area of compensation and issues related to them are discussed from the perspective of the participants. The complex issue of post trial access and current obligations under the law have been explored in the report. The report provides recommendations and future research agenda in the area of clinical trials.

 

The research study is priced towards the cost of postage etc. If you would like to place an order please contact Sama directly at sama.genderhealth@gmail.com

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