Topic-specific groups are among the key tools and resources established within the coalition to facilitate clinical research in low-resource settings.
Be it in the form of a working group, an advisory group or a support group, they consist of experts that are working together on specific research areas to support Coalition members and others conducting clinical research on COVID-19.
Questions and issues for groups come from:
- Investigators who submit queries
- Issues emerging in the work of experts within working groups
- Other working/advisory groups – cross-cutting issues may be tackled jointly by more than one working group and input invited from other groups.
The group members gather solutions, tools, documents, and advice on the website, either on their own sections or on the following sections:
The groups may:
- Suggest solutions to common problems
- Discuss and answer questions submitted by clinical investigators
- Review and share their opinions on materials and tools
- Discuss common challenges in their respective fields of expertise and share the outcomes
|Transversal research areas||Group description|
|Clinical Epidemiology||Support and promote the conduct of descriptive and predictive epidemiological studies using individual or aggregated data, and studies that assess the impact of COVID-19 on other diseases and on health systems, as well as health economics studies.|
|Clinical Management of COVID-19 in Resource-limited Settings||Identify key unanswered research questions to improve clinical management of COVID-19 in low-resource settings.
Develop clinical management standards adapted to different settings and contexts.
Develop or share existing clinical guidelines adapted to the management of severe patients in low-resource settings.
|Clinical Pharmacology and Drug Candidates||Provide advice on clinical pharmacology, drug analysis, and clinical pharmacometrics relevant to COVID-19 clinical trials.|
|Data Management||Provide guidance in best practice and choice of tools to ensure optimal data management and security.|
|Data Sharing||Provide best practice for data sharing, e.g., language in consent forms, organization of data, supporting documents, acceptance of terms of data sharing; define the policy for data contributor engagement for secondary use of data (choice of open access or controlled access, etc.).|
|Ethics||Support investigators with ethics questions in the development, review and/or validation of protocols and informed consent documents in the COVID-19 pandemic context.
Link national ethics review boards with guidance on specific subjects, when requested, including on issues related to data sharing, sampling, and fast-track review.
Provide inputs on community engagement and health care worker protection, where requested.
|Maternal, Newborn and Child Health||Facilitate appropriate inclusion of women (pregnant, breastfeeding or, more broadly, of childbearing age) and children in clinical trials of COVID-19 diagnostics, prophylaxis, and therapeutics.
Support use of safety registries for pregnant women in context of COVID-19 treatment.
|Regulatory||Facilitate rapid and joint protocol reviews and consideration of relevant import licenses by national regulatory agencies, through joint reviews for clinical approval and registration.|
|Social Science||Support and promote studies examining the social determinants of COVID-19, e.g., behavioural studies, ethical issues.|
|Study Design and Analytics||Advise on the design (including for adaptive studies), conduct, and statistical analysis of COVID-19 studies, including clinical trials.|
|Supply and Market Dynamics; Medicine Quality|| Assess production and distribution capacity for medicines and vaccines to inform countries and international agencies, and ensure adequate supply of effective interventions.
Conduct market dynamics analyses and interventions to scale up production.
Monitor and analyse medicine quality reports during the COVID-19 pandemic response, and facilitate dissemination of alerts.
|Virology, Immunology and Diagnostics||Regularly update a list, prices, and availability of validated tests (RT-PCR, serology, antigen detection etc.).
Review, adapt, endorse, and/or validate laboratory check lists and SOPs, including sample collection, handling, and analysis.
This working group is transversal, to discuss and provide information on validated diagnostic tools and relevant SOPs, checklists, etc.
For trials involving treatment of hospitalized COVID-19 patients, the Coalition recommends joining WHO’s SOLIDARITY trial.
Please note that these groups do not replace the normative guidance provided by the World Health Organization or the standard approvals process involving regulatory agencies or ethics review boards. Rather, these groups of experts can provide a sounding board for investigators who have questions while planning or conducting clinical research related to COVID-19, sharing valuable advice based on their knowledge and experience.
If you would like to propose yourself or someone else as an expert member of one of the working or advisory groups, please submit your contact and other information through our form.