Fair and equitable subject selection in concurrent COVID-19 clinical trials

Jansen, Maud O.; Angelos, Peter; Schrantz, Stephen; Donington, Jessica S.; Madariaga, Maria Lucia; Zakrison, Tanya L.

doi:10.1136/medethics-2020-106590

Cited by 6 publications

(9 citation statements)

References 14 publications

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“…The findings of this study should be helpful for developing clinical management strategies for infertile couples. However, there are some limitations in the present study ( Jansen et al, 2020 ; Niehus et al, 2020 ): (1) Retrospective cohort studies are always associated with selection bias issues, with selection bias being introduced, one might expect the result to be skewed in some ways. (2) In this study, our research subjects were all Chinese patients with infertility being given IVF/ICSI treatments during the COVID-19 pandemic.…”

Section: Discussionmentioning

confidence: 99%

Controlled Ovarian Hyperstimulation Protocol in Infertile Patients During the COVID-19 Pandemic

Zhang

Shi

et al. 2021

Front. Physiol.

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Objectives: To explore the appropriate controlled ovarian hyperstimulation (COH) protocols in infertility patients who received the in vitro fertilization (IVF)/intracytoplasmic sperm injection (ICSI) treatments during the COVID-19 pandemic.Materials and Methods: This retrospective cohort study evaluated the efficiency of the early follicular-phase long-acting GnRH-agonist long (EFLL) protocol (a new protocol developed by Chinese clinicians), prolonged pituitary down-regulation of EFLL protocol (Pro-EFLL), and the GnRH-ant protocol for couples meeting the study criteria between February 2020 and June 2020 who were treated by the First Affiliated Hospital of Zhengzhou University during the COVID-19 pandemic, and compared the pregnancy rates and miscarriage rates per fresh transfer cycle, number of retrieved oocytes, endometrial thickness on the day of hCG injection and the number of fertilized oocytes, mature oocytes, fertilized oocytes, and transferable embryos among the three protocols.Results: We found that the prolonged pituitary down-regulation during the COVID-19 pandemic by utilizing a full-dose of GnRH-a administrated in infertility patients were no differences in clinical outcomes than other protocols, The prolonged pituitary down-regulation protocol and EFLL protocol were associated with a higher Endometrial thickness on the day of hCG injection (12.67 ± 2.21 vs. 12.09 ± 2.35 vs. 10.79 ± 2.38, P < 0.001), retrieved oocytes (14.49 ± 6.30 vs. 15.02 ± 7.93 vs. 10.06 ± 7.63, P < 0.001), mature oocytes (11.60 ± 5.71 vs. 11.96 ± 6.00 vs. 7.63 ± 6.50, P < 0.001), fertilized oocytes (9.14 ± 5.43 vs. 8.44 ± 5.34 vs. 5.42 ± 5.20, P < 0.001), and transferable embryos (4.87 ± 2.96 vs. 6.47 ± 5.12 vs. 3.00 ± 3.28 vs. P < 0.001) in the GnRH-antagonist protocol.Conclusion: We recommend that patients start Gn injections 33–42 days after a pituitary downregulated full dose (3.75 mg) of gonadotropin-releasing hormone agonist during the COVID-19 pandemic, even a delay of 2–4 weeks does not affect the implantation rate. The study can provide a more detailed estimate and clinical management strategies for infertile couples during the COVID-19 pandemic.

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Section: Discussionmentioning

confidence: 99%

Controlled Ovarian Hyperstimulation Protocol in Infertile Patients During the COVID-19 Pandemic

Zhang

Shi

et al. 2021

Front. Physiol.

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“…No articles concerning enrolment in haemophilia trials were found, but two articles were identified that discussed participant selection in cystic fibrosis clinical trials with competitive enrolment [6,10] . One article specifically examined challenges in equitable subject selection for COVID-19 therapy trials [3] .…”

Section: Literature Searchmentioning

confidence: 99%

“…Of the strategies proposed and reviewed in the literature search, 'first come, first served' was a tactic that was generally not recommended, as it unfairly advantages those who can access or learn about treatments more quickly, and neither attempts to maximise benefits nor minimise harms with what limited resources are available [3,12,14] . Several of the articles reviewed explicitly stated the need to prioritise vulnerable patients or those with a medical need, indicating that protecting at-risk patients is a common priority [3,[11][12][13][14][15] . However, this may not necessarily be a consideration that carries over to clinical trials, as clinical trials have scientific aims to fulfil that scenarios involving resource allocation do not.…”

Section: Literature Searchmentioning

confidence: 99%

“…However, these strategies may also be highly subjective as there can be significant discrepancies in each investigator's judgement, their knowledge of facilitators and barriers to the patient's participation, and patient and investigator priorities when it comes to allocating treatments. Furthermore, approaches such as 'first come, first served' may not be equitable, since individuals with greater wealth, connections, or social capital may be able to access and enrol in trials earlier [3] . These enrolment decisions could have implications for the generalisability of the research findings and their ethical underpinnings.…”

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confidence: 99%

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Development of decision-making considerations to support equitable patient selection in paediatric haemophilia trials

Strike

Hamilton

et al. 2022

The Journal of Haemophilia Practice

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Background Clinical trials for investigational haemophilia treatments such as gene therapy offer a potentially life-changing opportunity to those who are selected for enrolment. However, the number of enrolment slots available for these trials is often greatly exceeded by the number of eligible patients. Many of the strategies that are commonly used to select candidates for participation can be highly unsystematic, inequitable, and subjective. A more rigorous set of criteria is therefore needed to evaluate each candidate's suitability for trial participation in order to eliminate bias in selection and fulfill the ethical principle of justice. Aims To review current knowledge and issues in patient selection for paediatric haemophilia clinical trials with competitive availability, and to develop a more objective standard for decision-making that takes into account the needs of all involved parties. Methods A literature search on the ethics of trial participant selection and the practice of fairly distributing limited medical resources was conducted to identify previous literature and best practices in the area. A list of essential decision-making considerations was then designed to guide the selection of paediatric participants for haemophilia therapy trials through iterative group discussions between a diverse team of health professionals at McMaster Children's Hospital, Hamilton, ON, Canada. Results Current practices in resolving this ethical issue are highly heterogenous, although there are some common themes and recommendations. The three main criteria supported by the team and the literature search for inclusion in the considerations were: medical need, need for support, and potential safety considerations for the patient. Three measures for evaluating each criterion were developed and added for consideration during the decision-making process. The role of patient selection in meeting the scientific aims of the trial was also considered. Conclusion Attempting to create an equitable, systematic decision-making procedure for clinical trial participant selection involves a wide variety of competing values and ethical considerations, and discrepancies between recommendations are commonplace. The criteria presented here are intended to be used as a guideline to assist the equitable selection of paediatric patients for participation in haemophilia clinical trials with highly limited enrolment, although it may have some applicability to other areas of clinical research or therapeutic areas concerned with the allocation of scarce medical resources. Next steps should involve speaking with patients, community members and other stakeholders in order to include their perspectives. Assessment of medical need, potential support needs, and safety considerations form the basis of criteria for discussions around how to make enrolment in paediatric haemophilia clinical trials more equitable © Shutterstock

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“…We focus on single-arm and randomized treatment trials, and we assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. 4 All these options have strengths and challenges. Covid-19 also has several distinct features that compound existing complexities.…”

Section: Allocation Ofmentioning

confidence: 99%

Allocation of Opportunities to Participate in Clinical Trials during the Covid‐19 Pandemic and Other Public Health Emergencies

Spector‐Bagdady¹,

Lynch²,

Bierer³

et al. 2021

Hastings Center Report

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Covid‐19 raised many novel ethical issues including regarding the allocation of opportunities to participate in clinical trials during a public health emergency. In this article, we explore how hospitals that have a scarcity of trial opportunities, either overall or in a specific trial, can equitably allocate those opportunities in the context of an urgent medical need with limited therapeutic interventions. We assess the three main approaches to allocating trial opportunities discussed in the literature: patient choice, physician referral, and randomization/lottery. As, we argue, none of the three typical approaches are ethically ideal for allocating trial opportunities in the pandemic context, many hospitals have instead implemented hybrid solutions. We offer practical guidance to support those continuing to face these challenges, and we analyze options for the future.

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Fair and equitable subject selection in concurrent COVID-19 clinical trials

Cited by 6 publications

References 14 publications

Controlled Ovarian Hyperstimulation Protocol in Infertile Patients During the COVID-19 Pandemic

Controlled Ovarian Hyperstimulation Protocol in Infertile Patients During the COVID-19 Pandemic

Development of decision-making considerations to support equitable patient selection in paediatric haemophilia trials

Allocation of Opportunities to Participate in Clinical Trials during the Covid‐19 Pandemic and Other Public Health Emergencies

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