Estimation of clinical trial success rates and related parameters

Previous estimates of drug development success rates rely on relatively small samples of pharmaceutical industry-curated databases, which are subject to potential sample selection biases. Using a sample of 185,994 unique entries of clinical-trial data for over 21,143 compounds from January 1st, 2000 to October 31st, 2015, we estimate aggregate success rates and durations of clinical trials. We also compute disaggregated estimates by stratifying across several features including: disease type, clinical phase, industry/academic sponsor, biomarker presence, lead indication status, and over time. In several cases, our results differ significantly from widely cited statistics. For example, oncology has a 3.4% success rate in our sample vs. 5.1% in prior studies. However, after declining to 1.7% in 2012, it has improved to 2.5% and 8.3% in 2014 and 2015 respectively. Also, trials with biomarkers have slightly lower success probabilities when all therapeutics groups are considered, but have much higher success probabilities in oncology and genitourinary diseases.

Department dc:contributor.department

Massachusetts Institute of Technology. Department of Electrical Engineering and Computer Science.

Grantor dc:publisher

Massachusetts Institute of Technology

Year dc:date.issued

2017

Author dc:creator

• Wong, Chi Heem

Advisor dc:contributor.advisor

• Andrew W. Lo.

• Electrical Engineering and Computer Science

Statement dc:rights

• MIT theses are protected by copyright. They may be viewed, downloaded, or printed from this source but further reproduction or distribution in any format is prohibited without written permission.

Licence dc:rights.uri

• http://dspace.mit.edu/handle/1721.1/7582

Language dc:language.iso

eng

Handle dc:identifier.uri

http://hdl.handle.net/1721.1/113964

OAI identifier oai:identifier

oai:dspace.mit.edu:1721.1/113964