Reasons why post-trial access to trial drugs should, or need not be ensured to research participants: a systematic review

N Sofaer, D Strech - Public health ethics, 2011 - academic.oup.com
Background: researchers and sponsors increasingly confront the issue of whether
participants in a clinical trial should have post-trial access (PTA) to the trial drug. Legislation …

The potential exploitation of research participants in high income countries who lack access to health care

R Dal‐Ré, A Rid, E Emanuel… - British journal of clinical …, 2016 - Wiley Online Library
There are millions of individuals living in North America and the European Union who lack
access to healthcare services. When these individuals participate in research, they are at …

Safeguarding children's rights in psychopharmacological research: Ethical and legal issues

M Kolch, A G. Ludolph, P L. Plener… - Current …, 2010 - benthamdirect.com
Objective: Research on psychopharmacological treatment in children and adolescents is the
subject of ongoing ethical discussion, as minors with mental disorders constitute a …

Reciprocity‐Based Reasons for Benefiting Research Participants: Most Fail, the Most Plausible is Problematic

N Sofaer - Bioethics, 2014 - Wiley Online Library
A common reason for giving research participants post‐trial access (PTA) to the trial
intervention appeals to reciprocity, the principle, stated most generally, that if one person …

Ethical issues in HIV prevention research with people who inject drugs

J Sugarman, SM Rose, D Metzger - Clinical Trials, 2014 - journals.sagepub.com
Background Injection drug use continues to significantly contribute to new infections with
HIV. Moreover, conducting HIV prevention research with people who inject drugs (PWIDs) …

Implementing post-trial access plans for HIV prevention research

A Paul, MW Merritt, J Sugarman - Journal of medical ethics, 2018 - jme.bmj.com
Ethics guidance increasingly recognises that researchers and sponsors have obligations to
consider provisions for post-trial access (PTA) to interventions that are found to be beneficial …

Mind the gap: an empirical study of post‐trial access in HIV biomedical prevention trials

B Haire, C Jordens - Developing World Bioethics, 2015 - Wiley Online Library
The principle of providing post‐trial access for research participants to successful products
of that research is widely accepted and has been enshrined in various declarations and …

Pharmaceutical companies vs. the State: who is responsible for post-trial provision of drugs in Brazil?

DWL Wang, OLM Ferraz - Journal of Law, Medicine & Ethics, 2012 - cambridge.org
This paper discusses so-called post-trial access to drugs for patients who participated in
clinical trials in Brazil. Brazil is currently a relevant country for the pharmaceutical industry …

The patient's safety and access to experimental drugs after the termination of clinical trials: regulations and trends

RE da Silva, AA Amato, TR Sousa… - European Journal of …, 2018 - Springer
Purpose Participants' rights and safety must be guaranteed not only while a clinical trial is
being conducted but also when a clinical trial finishes. The criteria for post-trial access to …

Fornecimento de medicamento investigacional após o fim da pesquisa clínica–Revisão da literatura e das diretrizes nacionais e internacionais

SM Dainesi, M Goldbaum - Revista da Associação Médica Brasileira, 2011 - Elsevier
A continuidade do tratamento com os medicamentos investigacionais após a conclusão de
uma pesquisa clínica vem sendo discutida desde o final dos anos 1980, inicialmente em …