Dataset Information

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

ABSTRACT: 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 and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. PURPOSE: to systematically review reasons why drug trial participants should, or need not be ensured PTA to the trial drug and the uses of such reasons. DATA SOURCES: databases in science/medicine, law and ethics, thesis databases, bibliographies, research ethics books and included publications' notes/bibliographies. Publication selection: a publication was included if it included a reason as above. See article for detailed inclusion conditions. Data extraction and analysis: two reviewers extracted and analyzed data on publications and reasons. RESULTS: of 2060 publications identified, 75 were included. These mentioned reasons based on morality, legality, interests/incentives, or practicality, comprising 36 broad (235 narrow) types of reason. None of the included publications, which included informal reviews and reports by official bodies, mentioned more than 22 broad (59 narrow) types. For many reasons, publications differed about the reason's interpretation, implications and/or persuasiveness. Publications differed also regarding costs, feasibility and legality of PTA. LIMITATIONS: reason types could be applied differently. The quality of reasons was not measured. CONCLUSION: this review captured a greater variety of reasons and of their uses than any included publication. Decisions based on informal reviews or sub-sets of literature are likely to be biased. Research is needed on PTA ethics, costs, feasibility and legality and on assessing the quality of reason-based literature.

SUBMITTER: Sofaer N

PROVIDER: S-EPMC3133737 | biostudies-literature | 2011 Jul

REPOSITORIES: biostudies-literature

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Publications

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

Sofaer Neema N Strech Daniel D

Public health ethics 20110711 2

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 and guidelines are inconsistent, ambiguous or silent about many aspects of PTA. Recent research highlights the potential importance of systematic reviews (SRs) of reason-based literatures in informing decision-making in medicine, medical research and health policy. PURPOSE: to systematically review reasons why drug tri ...[more]

PMID: 21754950

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Project description:To establish the empirical evidence base for the information that participants want to know about medical research and to assess how this relates to current guidance from the National Research Ethics Service (NRES). Medline, Web of Science, Applied Social Sciences Index and Abstracts, Sociological abstracts, Health Management Information Consortium, Cochrane Library, thesis index's, grey literature databases, reference and cited article lists, key journals, Google Scholar and correspondence with expert authors. Original research studies published between 1950 and October 2010 that asked potential participants to indicate how much or what types of information they wanted to be told about a research study or asked them to rate the importance of a specific piece of information were included. Studies were appraised based on the generalisability of results to the UK potential research participant population. A metadata analysis using basic thematic analysis was used to split results from papers into themes based on the sections of information that NRES recommends should be included in a participant information sheet. 14 studies were included. Of the 20 pieces of information that NRES recommend should be included in patient information sheets for research pooled proportions could be calculated for seven themes. Results showed that potential participants wanted to be offered information about result dissemination (91% (95% CI 85% to 95%)), investigator conflicts of interest (48% (95% CI 27% to 69%)), the purpose of the study (76% (95% CI 27% to 100%)), voluntariness (39% (95% CI 2% to 100%)), how long the research would last (61% (95% CI 16% to 97%)), potential benefits (57% (95% CI 7% to 98%)) and confidentiality (44% (95% CI 10% to 82%)). The level of detail participants wanted to know was not explored comprehensively in the studies. There was no empirical evidence to support the level of information provision required by participants on the remaining seven items. There is limited empirical evidence on what potential participants want to know about research. The existing empirical evidence suggests that individuals may have very different needs and a more tailored evidence-based approach may be necessary.

Project description:BackgroundThe use of great apes (GA) in invasive biomedical research is one of the most debated topics in animal ethics. GA are, thus far, the only animal group that has frequently been banned from invasive research; yet some believe that these bans could inaugurate a broader trend towards greater restrictions on the use of primates and other animals in research. Despite ongoing academic and policy debate on this issue, there is no comprehensive overview of the reasons advanced for or against restricting invasive research with GA. To address this gap, we conducted a systematic review of the reasons reported in the academic literature on this topic.MethodsSeven databases were searched for articles published in English. Two authors screened the titles, abstracts, and full texts of all articles. Two journals specialized in animal ethics, and the reference lists of included articles were subsequently also reviewed.ResultsWe included 60 articles, most of which were published between 2006 and 2016. Twenty-five articles argued for a total ban of GA research, 21 articles defended partial restrictions, and 14 articles argued against restrictions. Overall, we identified 110 reason types, 74 for, and 36 against, restricting GA research. Reasons were grouped into nine domains: moral standing, science, welfare, public and expert attitudes, retirement and conservation, respect and rights, financial costs, law and legal status, and longer-term consequences.ConclusionOur review generated five main findings. First, there is a trend in the academic debate in favor of restricting GA research that parallels worldwide policy changes in the same direction. Second, in several domains (e.g., moral standing, and respect and rights), the reasons were rather one-sided in favor of restrictions. Third, some prominent domains (e.g., science and welfare) featured considerable engagement between opposing positions. Fourth, there is low diversity and independence among authors, including frequent potential conflicts of interests in articles defending a strong position (i.e., favoring a total ban or arguing against restrictions). Fifth, scholarly discussion was not the norm, as reflected in a high proportion of non-peer-reviewed articles and authors affiliated to non-academic institutions.

Dataset Information

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

Publications

Reasons Why Post-Trial Access to Trial Drugs Should, or Need not be Ensured to Research Participants: A Systematic Review.

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