Topic-specific working groups are among the key tools and resources being established to facilitate clinical research in low-resource settings.
The working groups consist of experts that are working together on specific research areas to support Coalition members and others conducting clinical research on COVID-19.
The working 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||Working group description|
|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.
|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.|
|Study Design and Analytics||Advise on the design (including for adaptive studies), conduct, and statistical analysis of COVID-19 studies, including clinical trials.|
|Clinical Pharmacology and Drug Candidates||Provide advice on clinical pharmacology, drug analysis, and clinical pharmacometrics relevant to COVID-19 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 & 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.
|Maternal, Newborn & 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.
|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.).|
|Data Management||Provide guidance in best practice and choice of tools to ensure optimal data management and security.|
|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.|
|Social Science||Support and promote studies examining the social determinants of COVID-19, e.g., behavioural studies, ethical issues.|
|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.
For trials involving treatment of hospitalized COVID-19 patients, the Coalition recommends joining WHO’s SOLIDARITY trial.
Please note that these working 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 groups, please submit your contact and other information through our form.