Post-trial responsibilities beyond post-trial access

Cho, Hae Lin; Danis, Marion; Grady, Christine

doi:10.1016/s0140-6736(18)30761-x

Cited by 33 publications

(42 citation statements)

References 3 publications

(1 reference statement)

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“…So, it is important to note that post-trial care safeguards participants who do not have or have insufficient access to health care outside of research. These participants include people from low-income and middle-income countries and people who are uninsured or otherwise lack sufficient access to health care in high-income countries [2].…”

Section: Discussionmentioning

confidence: 99%

“…The recommendation proposed by the participants of the meeting corroborates the results found in a study conducted by Dainesi [4] in which the author also describes that there was a consensus on the part of the research groups, members of the REC and also sponsors that, with continuity of treatment, this should be provided by the sponsor and free of charge. However, although widely discussed, obligations to post-clinical patients refer only to medical care, not covering all the care they need [2]. In addition, there are many recommendations for cases where medicines bring benefits to patients, but lack the necessary care regulations when medicines fail in their primary goals, in special in order to maintain access to continued monitoring, treatment for complications, or existing treatment alternatives [14].…”

Section: Discussionmentioning

confidence: 99%

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Who should pay for the continuity of post-trial health care treatments?

Iunes

Uribe

Torres

et al. 2019

Int J Equity Health

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Background The bioethical debate in the world on who should pay for the continuity of post-trials treatment of patients that have medical indication remains obscure and introduces uncertainties to the patients involved in the trials. The continuity of post-trial treatment was only incorporated in the 2000s by the Helsinki Declaration. The Universal Declaration on Bioethics and Human Rights, published in 2006, points out that post-trial continuity may present a broader scope than just the availability of the investigated medicine. In the latest version of this Declaration, in 2013, it was stated that “prior to the start of the clinical trial, funders, researchers and governments of the countries participating in the research should provide post-trial access for all participants who still require an intervention that was identified as beneficial. This information should also be disclosed to participants during the informed consent process”. However, a systematic review on the registration of phase III and IV clinical trials, from the clinical trials website, demonstrated that the understanding of the various guidelines and resolutions is conflicting, generating edges in the post-trial setting. For the health authorities of countries where clinical trials take place, the uncertainties about the continuity of the treatments generate gaps in care and legal proceedings against health systems, which are forced to pay for the treatments, even if they are not included in the list of medicines available to the population. Methods Fifty-one representatives from the health, judicial, legislative, patient and academic organizations of eight countries of Latin American and South Korea took part in a meeting in Chile, in 2017, to discuss the responsibility of the treatment continuation after clinical trials. From a hypothetical case of development of a new drug and its studies of efficacy and safety, the participants, divided in groups, proposed recommendations for the problem and pointed out the pros and cons of adopting each recommendation. The groups were, afterwards, confronted by a simulated jury and, finally, issued a final recommendation for the problem. Then, an analysis was made on the content of the recommendations and the pros and cons in adopting conservative or liberal positions, besides the possible impacts of a restrictive regulation regarding the conduction of clinical trials, pointed out by the groups, before and after the simulated jury. Results The theme was widely discussed and about 12 recommendations were proposed by the participants. The main ones took into account aspects related to patients’ rights, economic factors and the development of new technologies, above the position of industry and research institutes, as well as the legislation in force in each country. Conclusion The countries of Latin America and South Korea, currently, do not have laws that address patients’ rights, moreover, there is no...

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Section: Discussionmentioning

confidence: 99%

Section: Discussionmentioning

confidence: 99%

Who should pay for the continuity of post-trial health care treatments?

Iunes

Uribe

Torres

et al. 2019

Int J Equity Health

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“…26 There is growing emphasis on the obligations researchers and funders have to consider arrangements for post-trial care for participants. 27,28 Within this context, questions prompted by this exploratory analysis include: (1) What is the role of the principle investigator and the IRBs in ensuring continued high standards of care given that clinical trial standards of care are often superior to the country standard of care in resource-constrained settings? and (2) What can participants negotiate for, and from whom, in terms of their continuity of care?…”

Section: Suggestions For Future Transition Improvementsmentioning

confidence: 99%

Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya

et al. 2018

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We conducted an exploratory analysis of former HIV Prevention Trials Network 052 (HPTN 052) clinical trial participants in 2016 to assess their (1) satisfaction with the HPTN 052 clinical trial care and treatment, and reasons for joining the trial; and (2) perspectives about the post-trial transition to public HIV care centers. Quantitative data showed that, of the 70 survey participants, 94.3% (n = 66) reported being very satisfied with the care and treatment they received while participating in the clinical trial and 51.4% (n = 36) reported they joined the study because they would receive information to improve their own or their partner's health. Qualitative data (five in-depth interviews and two focus group discussions) analysis revealed the following themes: transition experiences; perceived superior clinical trial care; study benefits not offered at public HIV care centers; and the public HIV care centers' indifference to the uninfected partner. For some HPTN 052 participants, transition to HIV care clinics was disappointing. Clinical trial investigators and local Institutional Review Boards should consider the need for safeguards and oversight of post-trial health care for trial participants after the trial ends, especially in resource-constrained settings, to avoid negative health outcomes.

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“…The copyright holder for this this version posted November 16, 2020. ; https://doi.org/10.1101/2020.11.14.20231720 doi: medRxiv preprint 3 trial closure (Cho et al, 2018). Additionally, the need for monitoring and compensation for potential adverse effects from trial interventions (Lawton et al, 2019), and provision of trial feedback (Chen et al, 2016;Schroter, Price, Malički, Richards, & Clarke, 2019), have been key concerns in post-trial (research) ethics.…”

Section: Introductionmentioning

confidence: 99%

“…Post-trial obligations have been largely understood to mean the obligation of researchers to provide a proven intervention to the respective trial participants beyond trial participation (Lawton et al, 2019). However, in some types of research, especially those involving chronic conditions, post-trial obligations may necessitate going beyond the provision of trial products/interventions, to incorporate a range of other on-going services such as continued care and management of the disease condition and related psychosocial services (Cho, Danis, & Grady, 2018; Lawton et al, 2019). In research involving HIV infected persons, there is need for continued/lifelong provision of HIV treatment, care and support, which requires referral and adequate linkage to alternative care facilities, and follow up beyond the period of trial closure (Cho et al, 2018).…”

Section: Introductionmentioning

confidence: 99%

Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

Nalubega

Cox

Mugerwa

et al. 2020

Preprint

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There is a gap in evidence regarding how research trial closure processes are managed to ensure continuity of HIV care for HIV positive participants following trial closure within low income settings. This research aimed to establish how research staff in Uganda understood and practised post-trial care for HIV positive trial participants. A grounded theory study was conducted using in-depth individual interviews and focus group discussions with 22 research staff from 3 different trials in Uganda, in 2014-2015. The results indicated that researchers engaged in three main activities to support trial participants, including; (i) preparing for post-trial care, which included instituting trial closure guidelines, planning necessary resources, and informing trial participants about post-trial care; (ii) facilitating participants during trial exit by engaging in psychological and practical support activities, and (iii) providing follow up care and support for participants after trial exit, to respond to the needs of trial participants which often arose after trial exit. This study established a need for a holistic approach to post-trial-care of HIV positive trial participants in Uganda, and the need to engage multiple stakeholders including ethics authorities.

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Post-trial responsibilities beyond post-trial access

Cited by 33 publications

References 3 publications

Who should pay for the continuity of post-trial health care treatments?

Who should pay for the continuity of post-trial health care treatments?

Participant satisfaction with clinical trial experience and post-trial transitioning to HIV care in Kenya

Ethical and practical considerations in HIV drug trial closure: perspectives of research staff in Uganda

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