Abstract
Many clinical trials are terminated before reaching the sample size needed to test the trials' hypotheses owing to poor recruitment.
Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.
Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.
We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.
This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.
Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.
Registries, such as ClinicalTrials.gov, provide information on the main features of a multicenter clinical trial (MCT) to the general public.
Site investigators are key to the success of MCTs; however, information on their recruitment performance is not publicly available.
We propose that sponsors should disclose the recruitment targets of all site investigators on ClinicalTrials.gov before a trial starts as well as their final recruitment. Information on issues that could have affected recruitment should also be provided.
This information will be of interest to different stakeholders such as patient organizations, sponsors, and MCT networks.
Disclosing all site investigators' recruitment figures could prompt queries to the sponsor from the scientific community about regional subgroup analyses, to assess if ethnic or standard-of-care differences have an impact on treatment outcomes.
| Original language | English |
|---|---|
| Article number | e1001149 |
| Number of pages | 4 |
| Journal | PLoS Medicine |
| Volume | 8 |
| Issue number | 12 |
| DOIs | |
| Publication status | Published - 27 Dec 2011 |
Keywords
- research ethics committee
- publication
- clinicaltrials.gov
- randomized controlled-trials
- cancer trials
- statement
- registration
- sample-size
- journal-editors
- protocols
Access to Document
- Disclosure of investigators
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