February 24, 2021 – Following a meeting of INVENT Council on February 17, 2021 via teleconference, the network has approved and adopted new changes to the network’s Study Endorsement Policy & Procedure Documents. The changes are intended to both better specify acceptable research study designs for consideration of endorsement and improve the study endorsement review process.
Prior to the adoption of the new policy, applicants were eligible to apply for study endorsement with “academically-driven clinical research studies that are seeking to recruit participants in multiple countries must be one of the following designs.” Effective immediately, accepted research designs are now restricted to:
- Randomized controlled trial (RCT) or a pilot trial to inform an RCT;
- Quasi-experimental (non-randomized) study evaluating a treatment, intervention, management strategy or diagnostic strategy. Participants in one or more groups are managed uniformly as prescribed by the protocol, with a specific hypothesis, e.g. “risk of recurrent VTE will be less than 2% over 90 days if using this strategy”.
The adopted changes to policy were supported by Council members in an effort to ensure the network is endorsing the highest quality of clinical research studies that have the potential to change clinical practice. Additional changes to the Study Endorsement Policy & Procedure Documents include a new required study summary template for applicants and a revised review process of any application before consideration by Council.
To view the newly adopted policy, please visit our website here.