What is it about?
Our paper is the first systematic analysis of clinical trial results in Clinicaltrials.gov. First, we find that there is no abnormal concentration of results just above the significance threshold, something that has instead been documented for results published in academic journals across a number of disciplines. This is good news about integrity of reported trials. Second, we document that sponsors with more favorable phase II results are more likely to continue to phase III investigations. So, incentives do matter, as they should. Third, we find that part of the excess amount of phase III significant results relative to phase II remain unexplained for small industry sponsors. This suspicious pattern is consistent with some selective reporting and suggests the need of tightening enforcement of registration regulation, especially for small industry sponsors.
Photo by Kendal on Unsplash
Why is it important?
Pharmaceutical companies make massive up-front investments to develop drug and under pressure on investigators to deliver positive results as fast as possible. So, we cannot take integrity for granted. Our results reassure us about the integrity of results reported at Clinicaltrials.gov, while also raising some concerns and new questions.
Read the Original
This page is a summary of: P-hacking in clinical trials and how incentives shape the distribution of results across phases, Proceedings of the National Academy of Sciences, June 2020, Proceedings of the National Academy of Sciences, DOI: 10.1073/pnas.1919906117.
You can read the full text:
The following have contributed to this page