C. Developing new norms and standards tailored to the epidemic context.
The Blueprint will foster the development of innovative study designs for priority pathogens, starting with vaccines. A cadre of leading epidemiologists, statisticians, infectious disease modellers, clinical trialists and regulatory experts was engaged by WHO in early 2016 and is contributing to this area of work. The Clinical REsearch During Outbreaks (CREDO) initiative will use these trial design tools during their training sessions and their trainees will provide feed-back to help improve the tools.
To promote transparent and fair collaborations WHO, in collaboration with Médécins Sans Frontières (MSF) and the Institute Pasteur, is reviewing the principles and legal language of general agreement forms and guidelines to support framing of collaborations. To ensure that biological samples can be available for R&D and that new interventions can be evaluated, partners (MSF and Oxford University, notably) are developing open platforms for samples’ biobanking and sharing.
Related to this effort, the Blueprint is developing a Material Transfer Agreement (MTA) capacity building tool to encourage research entities and countries to share materials openly for the benefit of public health and science. This work builds on an initiative by Chatham House to facilitate data sharing through a web-based tool. WHO will also pursue effort to develop global norms for data sharing, under a partnership led by Wellcome Trust.
This area of work is comprised of 2 workstreams (see details below):
- Clinical trial designs
- Data & sample sharing
Clinical trial designs
Working group for vaccine evaluation (4th consultation)
Working group for therapeutic evaluation (1st consultation)
Good participatory practices
Data & sample sharing
- 1. Global coordination mechanism
- 2. Funding
- 3. Communication
- 1. Disease prioritization
- 2. Roadmaps & Target product profiles
- 3. Regulatory & Ethical pathways
- 1. Clinical trial designs
- 2. Data & sample sharing