INSTITUTE CONFIDENTIALITY INSTITUTE REPRESENTATIVES PUBLICATIONS
PUBLICATIONS
December 2016
Press releases for Phase 2 clinical trial topline results: Have the objective pre-specified efficacy results been disclosed?

Zheng Su, Christine Livoti
Contemporary Clinical Trials Communications
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a b s t r a c t

Phase 2 clinical trials are of vital importance in the drug development process as they usually gather preliminary evidence of efficacy of potentially new therapies and support the go/no-go decision for Phase 3 pivotal trials. Topline results of Phase 2 trials are typically first disclosed through press releases so that key stakeholders (patients and their advocacy groups, physicians, clinical trials practitioners, investors, etc.) can have timely access to a high level summary of the important findings. The sponsors of the trials often will save more detailed findings for future medical conference presentations and/or peer-reviewed journal publications, and as a result there may be an extended period of time where only the topline results are available on which stakeholders can rely. It is therefore critical for trial sponsors to release objective findings and avoid selective disclosure of favorable results.