The GFBR will hold a two-day meeting in Bangkok, Thailand, on 28-29 November 2017 on the theme of: “the ethics of alternative clinical trial designs and methods in low- and middle- income country research”.
Alternative clinical trial designs and methods are increasingly being used in place of the conventional randomised controlled clinical trial (RCT) in low- and middle- income countries (LMICs). These approaches – including adaptive, cluster randomised and stepped wedge designs and controlled human infection models – offer a number of potential advantages, including accelerating vaccine or drug development and making the clinical trial process more socially acceptable. However, the ethical implications of these designs on risks and potential benefits to participants, consent, scientific rigour, trial efficiency (including study population size), have not been adequately addressed. These uncertainties are further compounded by current guidance which was largely written without special consideration of new trial designs, leaving researchers, research ethics committees and regulators with little support in how to evaluate, implement and run these often complex trials. There is a pressing need for the global bioethics and research community and regulators to find mutual ground for discussion and a shared understanding of the challenges and opportunities presented by these alternative approaches; only then will their full potential to address the health needs in LMICs be realised.
As part of the upcoming meeting, the GFBR is seeking case studies that bring attention to key ethical issues that have emerged when conducting alternative clinical trial designs and methods in LMIC settings. We will also be having panel sessions, including a panel on guidance and policy issues. We are seeking proposals that provide an overview and critique of existing guidance on alternative trial designs and methods and/or identify gaps in current guidance and propose solutions (e.g. design-specific guidance). We also welcome proposals that highlight the policy issues associated with the use of these designs and methods in a LMIC setting.
The GFBR is also seeking participants to attend the meeting, with places awarded on a competitive basis.
This notice contains details on the following:
- CALL FOR CASE STUDIES
- CALL FOR PROPOSALS ON GUIDANCE AND POLICY ISSUES
- CALL FOR PARTICIPANTS
- DEADLINE
- AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING
- NOTIFICATION
- CHECKLIST FOR APPLICANTS
All applicants are encouraged to read the background paper for further details on the meeting theme.
If you have any questions about this call please email gfbr@wellcome.ac.uk.
1. CALL FOR CASE STUDIES
We invite applicants to submit case studies highlighting ethical issues associated with “the ethics of alternative clinical trial designs and methods in LMIC research”. These case studies could: demonstrate the development of good practice; highlight challenges; demonstrate situations in which ethical practice failed; or present unresolved questions for the global community. We welcome case studies from any stakeholder perspective, including policy-makers, researchers, clinicians and healthcare workers. Case studies should focus on issues around conducting research.
Support will be provided to successful applicants for developing the case studies into a format suitable for them to present at the meeting[1]. It is anticipated that case studies will be presented by their authors, one or two experts will provide commentary on the issues presented, and then participants at the meeting will discuss the challenges and questions raised by the case studies.
Case studies should be 2 pages maximum (in Microsoft Word or pdf format), clearly articulated in English and contain the following sections:
- Title
- Brief description of the research project
- Background – relevant facts about the host country/community and disease studied
- Ethical issues
- Commentary on the issues, conclusions and/or recommendations for discussion or future research
In general, case studies should focus on research in LMICs[2] and highlight no more than three ethical issues for discussion. These might be framed around – but are not limited to – the following questions:
- Under what circumstances and why is an alternative design or method ethically preferable to a conventional RCT in the context of research in LMICs?
- What benefits do alternative designs and methods (such as adaptive trials) offer LMIC participants in comparison to RCTs and how do they compare in terms of acquiring information for the general clinical community?
- What are the opportunities and barriers for implementing alternative designs and methods in LMICs?
- What makes alternative trial designs and methods ethically challenging (or better) in LMICs?
- What are the ethical and practical issues of alternative designs and methods. Are these factual or assumed?
- How should investigators explain complex information to a prospective participant to ensure that they understand the alternative trial design before enrolling?
- How best can investigators engage with local communities to assess acceptability (for social, cultural, political or ethical reasons) of the study design?
- Under what circumstances/criteria would the conditions be satisfied for providing a waiver on individual consent during a cluster-level interventions?
- How well are alternative trial designs and methods understood by different research stakeholders in LMICs (e.g. investigators, research ethics committees (RECs), and regulatory authorities)? How can local RECs and regulatory authorities be supported to better understand and evaluate these complex trials?
In addition, please provide the following information in Microsoft Word or pdf format:
- Short letter of intent not exceeding one page, outlining why you would like to participate in the GFBR meeting
- Name, institution and contact information
- Short CV (1-2 pages) clearly stating:
- Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, biostatistics, policy-making, regulatory, public health etc.)
- Your career stage (early, mid, senior)
- Contact information and email addresses of two references
- Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
If you are unsure about the suitability of a possible case study or would like to discuss your proposed case study further, please email gfbr@wellcome.ac.uk.
2. CALL FOR PROPOSALS ON GUIDANCE AND POLICY ISSUES
We are seeking proposals that provide an overview and critique of existing guidance or policy issues on alternative trial designs and methods and/or identify gaps in current guidance and propose solutions. The proposal could relate to guidance or policy issues at the national, regional or international level, including addressing regulatory challenges.
Proposals might be framed around – but are not limited to – the following questions:
- What are the governance and regulatory needs and how can these be addressed e.g. through the development of design-specific guidance?
- Can guidance help to address some of the ethical challenges and if so, what form should these take and what should they include?
Support will be provided to successful applicants for developing their proposal into a format suitable for them to present at the meeting as part of a panel.
Proposals should be no more than 2 pages maximum (in Microsoft Word or pdf format), clearly articulated in English and contain the following sections:
- Title
- Brief description of the context e.g. what guidance or policy issue will you address, is it national/regional/international and which trial design(s) or method(s) does it relate to.
- Commentary, conclusion and recommendation
In addition, please provide the following information in Microsoft Word or pdf format:
- Short letter of intent not exceeding one page, outlining why you would like to participate in the GFBR meeting
- Name, institution and contact information
- Short CV (1-2 pages) clearly stating:
- Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, biostatistics, policy-making, regulatory, public health etc.)
- Your career stage (early, mid, senior)
- Contact information and email addresses of two references
- Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
If you are unsure about the suitability of your proposal and would like to discuss it, please email gfbr@wellcome.ac.uk.
3. CALL FOR PARTICIPANTS
Who can attend the GFBR meeting?
The majority of participants are selected through a competitive process[3]. Up to 80 participants will be selected from those eligible who submit an application to attend by the deadline. We are seeking broad geographical representation, a mix of disciplinary expertise including researchers, clinicians, healthcare workers, bioethicists, policy-makers, health system functionaries and lawyers, and a combination of people who are early in their careers and leaders in their fields. Viagra helped me when about six months ago I’ve lost the erection all at once because of the stressful situation I’ve got into. The doc said that it can restore over time, but I wasn’t ready to wait. So he said I could take 100 mg Viagra pill before sex. Thank God it worked! I can say that Viagra literally saved my relationships.
To submit an application to attend, please provide the following information in Microsoft Word or pdf format, in English:
- Short letter of intent not exceeding one page, outlining:
- Why you would like to participate in the GFBR meeting;
- What you can contribute to the meeting. Please note we are looking for people who have an interest in or experience of working on clinical trials.
- Name, institution and contact information
- Short CV (1-2 pages)
- Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, biostatistics, policy-making, regulatory, public health etc.)
- Your career stage (early, mid, senior)
- Contact information and email addresses of two references
- Whether you require funding to cover travel and accommodation costs, or you are self-funding. Please note that funding will be prioritised for applicants from LMICs. Applicants from other countries are welcome to apply if they can self-fund their attendance.
4. DEADLINE
All applications should be sent to gfbr@wellcome.ac.uk by 21.00 BST on Tuesday 30 May 2017, in English. Please specify in the subject line whether you are applying to attend, present a case study or present on guidance or a policy issue. Applications received after the deadline will not be considered.
5. AWARDS: DECISION MAKING AND ELIGIBILITY FOR FUNDING
Successful applicants from low-and middle-income countries who require full funding will receive an award to cover:
- return travel to the meeting (economy airfare and standard ground transportation costs);
- accommodation (2 or 3 nights maximum, including meals);
- a single entry visa (if required).
Participants will be expected to meet all other costs.
The GFBR Planning Committee will select successful candidates (both self-funded and those applying for funded places). The selection committee will consider the following factors when considering the applications:
- Country of origin. We would like to ensure a representative distribution of participants from different regions;
- Background/current area of expertise. We would like to seek representation from many different disciplines relating to the theme of the meeting;
- Experience of ethical issues related to clinical trials;
- Reasons for attending the meeting. We hope to attract participants who will be able to actively contribute to the meeting and who expect to achieve impact from the meeting;
- Case study applications and guidance/policy proposals only: Relevance of the case/proposal to the meeting theme and research in LMICs.If your case study or guidance/policy proposal is not selected your name will automatically go forward to be considered in the applications to attend. Applicants are strongly encouraged to submit a case study or a proposal on guidance and policy issues.
6. NOTIFICATION
All applicants will be informed of the Planning Committee’s decision in the week of the 10 July 2017. The decision of the committee will be final.
7. CHECKLIST FOR APPLICANTS
Please use the following checklist to make sure you have provided all the requested information in your application, in English.
| All applicants: | Short letter of intent (1 page) |
| Your name | |
| Your institution | |
| Your contact information | |
| Short CV (1-2 pages) stating clearly:
· Your primary discipline (e.g. clinical research, medicine, ethics, sociology, law, biostatistics, policy-making, regulatory, public health etc.) · Your career stage (early, mid, senior) |
|
| Contact information and email addresses of two references | |
| Whether you require funding to cover travel and accommodation costs, or you are self-funding | |
| In addition, for case study proposal: | Title of case |
| Brief description of the research project | |
| Background – relevant facts about the host country/community and disease studied | |
| Ethical issues | |
| Commentary, conclusions and recommendations | |
| In addition, for guidance or policy issue proposal: | Title |
| Brief description of the context e.g. what guidance or policy issue will you address, is it national/regional/international and which trial design(s) or method(s) does it relate to. | |
| Commentary, conclusion and recommendation |
[1] For guidance on how to write a case study, please see the case studies from last year’s GFBR meeting.
[2] However, we do not want to exclude case studies from high income countries if there could be valuable lessons to learn, and some parallel or relevant ethical considerations, for example, this may include adaptive trial design with indigenous populations in countries like Australia and Canada. If your case study relates to a high income country please use the commentary section to draw-out the relevance for research in LMICs.
[3] The GFBR also directly invites a number of participants e.g. expert speakers or representatives of key organisations.