A Method to Redesign and Simplify Schedules of Assessment and Quantify the Impacts. Applications to Merck Protocols.

Steven R Cummings^1,2, Scott Chetham³, Andy Lee⁴

¹San Francisco Coordinating Center, California Pacific Medical Center Research Institute, Mission Hall: 550-16th Street, 2nd Floor, 94143, San Francisco, CA, USA. Steve.cummings@gmail.com.

²Department of Epidemiology and Biostatistics, University of California, Mission Hall: Box #0560 550- 16th Street, 2nd Floor, 94143, San Francisco, CA, USA. Steve.cummings@gmail.com.

³Faro Health Inc, 3366 N Torrey Pines CT, Suite 225, 92037, La Jolla, CA, USA.

⁴Global Clinical Trial Operations, Merck & Co., Inc, Rahway, NJ, USA.

PubMed PMC DOI PDF

Abstract

The growing complexity of biopharmaceutical sponsored trials has adverse impacts on increased burdens on participants, clinical sites, and sponsors, including greater difficulty recruiting and retaining participants, difficulty engaging sites to participate in trials, excessive cost of trials, and increased cycle times. The schedule of assessments (SoAs) is the origin of and blueprint for complexi…

Create a free account to keep reading

Free members get 10 full research views every month across publications, clinical trials, FDA clearances, adverse events, and NIH grants. No credit card required.

Create Free Account Sign In

Want unlimited research access? See Pro plans

Data Accuracy Notice: Research intelligence on Health AI Central is aggregated from public sources (PubMed, ClinicalTrials.gov, FDA, NIH, CMS, and others) and refreshed nightly. Classifications and derived metrics are produced by automated methods described in our Methodology. We recommend verifying critical data points against the primary sources before making decisions.