Feedback form for the public consultation for WHO guidance for global practices for clinical
trials
Please note we are providing this word file of the full list of questions to help you plan your
online submission
–
DO NOT make a submission using the word file, the submission should
be through the online form. Wherever possible, please coordinate one submission per
organization or per institution using the word file to collate input into consolidated
submissions through the online form.
Personal information:
Last name
Organization/
Affiliation
E-mail (optional)
Matthews
STRIVE research consortium
First name
Country of residence
organization/affiliation
or
Gail
Global network
General comments:
Please provide general comments on addressing context-specific issues, considerations, and implications for adapting and
implementing the guidance, as well as identifying gaps in the evidence that should be addressed through future research. Please
also provide any comments about the strengths of the draft guidance. Feedback to specific content to enhance clarity, address
technical errors, and provide any missing information will be in the
suggested amendments.
This feedback is
provided
on behalf of
the
STRIVE research
consortium
(https://insight.ccbr.umn.edu/i18/). STRIVE (Strategies and Treatments for Respiratory Infections and
Viral Emergencies) is a global network of networks formed as a broad international research
collaboration in 2022 in the aftermath of the COVID pandemic. STRIVE is primarily funded by the
United States National Institutes of Health (NIH) and has developed a master protocol which currently
guides 2 multi-site clinical trials. STRIVE is an outgrowth of the Accelerating COVID-19 Therapeutic
Interventions and Vaccines (ACTIV) public-private partnership sponsored by NIH, with the
infrastructure provided by the ACTIV-3 initiative and sites from ACTIV-1, ACTIV-3, ACTIV-5 and
ACTT. STRIVE is aimed at improving the clinical outcomes of patients with acute severe infections
while being prepared to respond to infectious disease emergencies, through the rapid implementation of
clinical trials designed to inform practice guidelines, public health policy, and the delivery of health care.
With 200+ collaborating sites in 40+ countries on all six inhabited continents, and with substantial
expertise and
experience in conducting RCT’s
globally to address research questions of public health
relevance, STRIVE is an example of an international consortium that can inform considerations to
establish a well-functioning global trial ecosystem. Our feedback below reflects wide consultation among
the key STRIVE stakeholders.
Some general comments to the draft guidance from WHO:
The document is well-structured and concise. It covers some of the relevant topics required for a much-
needed strengthening of the global clinical trials ecosystem, and the specific guidance is largely
consistent
with STRIVE’s perspective on global trials.
The WHO is to be complimented for serving a
convening role.
Nonetheless, we think that the WHO’s unique role could be used to further coordinate
and advocate for work across governments in support of global clinical trials designed to address global
health emergencies.
Some areas could be strengthened:
The definition of
the “global clinical trial ecosystem” is
critical to the overall message but is
underdeveloped. An ecosystem is defined by its relevant actors and the systems in place that mediate
their interaction. From our perspective, the critical actors are governments, funders, regulators, ethics