Grand Rounds July 15, 2022: Overview of Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV) Public-Private Partnership and Lessons Learned (Stacey J. Adam, PhD)

Speaker

Stacey J. Adam, PhD
Associate Vice President, Research Partnerships
Foundation for the NIH

 

 

Keywords

ACTIV, COVID-19, FNIH

 

Key Points

  • The normal timeline for public-private partnerships is around 9 months of planning. ACTIV was stood up in about a month, launching on April 17, 2020, to develop a coordinated research response to speed COVID-19 treatment and vaccine options. There were four ACTIV fast-track focus areas: vaccines, preclinical, clinical trial capacity, and therapeutics – clinical.
  • In the therapeutics arm, the most promising therapeutic agents for COVID-19 were prioritized. Candidate agents were triaged based on concurrent clinical trials, completion of a multiple ascending dose study, and availability of preclinical data before being scored based on predefined criteria. From this review, 11 ACTIV master protocols were developed.
  • Having the ability to use the resources from the public and private sectors as much as possible, having sufficient funding and staffing, and having clear communication were all quintessential to getting things running quickly.
  • Since the protocols have launched, 20,000+ patients have enrolled at more than 620 sites across numerous networks, 11 protocols were developed, 10 launched, with 26 publications across 13 journals. The team reviewed 800 candidates over 2 years time. We selected 35 and completed testing of 27 of them. Six agents showed really good results and either changed clinical practice or showed efficacy and improved patient care. Five agents are still in testing.
  • Each protocol has had many lessons learned. Across all is the need for clear communication, resources, and partnerships.

Discussion Themes

How did the public-private partnership contributed to the success of ACTIV? Having the companies at the table, bringing the resources (man power, willingness to test, openness of conversation) was amazing and contributed to success of the program.

Foundation for NIH was involved from the beginning because we had successfully done the public-private partnerships for other initiatives, we had the stakeholder relationships to get everyone to the table, and our involvement allowed for rapid, targeted donations from private sector.

 

Read more in Annals of Internal Medicine and Critical Care Medicine.

View the Summary of NIH-Funded ACTIV/ACTIV-Associated Clinical Trials.

Tags

#pctGR, @Collaboratory1