Post-trial access

Pintail Usharani, Syed Mujtaba Hussain Naqvi | Perspectives in Clinical Research | PubMed Central (PMC) | NCBI | Jan-Mar 2013; 4(1): 58–60 Globalization of clinical research introduced several new challenges to the major stakeholders. These emerging aspects are dealt by regulators by providing and updating guidelines, making recommendations, formulating and amending… Continue reading

At the end of the Clinical Trial: Does access to investigational technology end as well?

Richard S. Saver | Western New England Law Review | Volume 31, Issue 2 | 2009 Medical research subjects increasingly are demanding (and litigating about) continued access to investigational technology after the clinical trial has concluded. The Article undertakes a critical review of the legal, ethical, and policy issues that… Continue reading

“We Have Our Protector”: Misperceptions of Protection Against HIV Among Participants in a Microbicide Efficacy Trial

Joanne E. Mantell, Neetha S. Morar, Gita Ramjee | American Journal of Public Health | June 2006 | Source: NCBI-PubMed   Abstract Objectives We examined perceptions of the effectiveness and acceptability of a candidate microbicide among 94 South African female sex workers who had participated in a phase 3 microbicide… Continue reading

Equitable treatment for HIV/AIDS clinical trial participants: a focus group study of patients, clinician researchers, and administrators in western Kenya

D. N. Shaffer, V. N. Yebei, J. B. Ballidawa, J. E. Sidle, J. Y. Greene, E. M. Meslin, S. J. N. Kimaiyo, W. M. Tierney | Journal of Medical Ethics | January 2006 | Source: NCBI-PubMed A qualitative study with focus groups to describe the concerns and priorities of key stakeholders in a developing country regarding… Continue reading