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Sponsor-Imposed Publication Restrictions Disclosed on ClinicalTrials.gov
Serina Stretton1, Rebecca A Lew1, Julie A Ely1
1a ProScribe-Envision Pharma Group , Sydney , New South Wales , Australia.
Accountability in Research
|July 21, 2015
Summary
Many sponsor publication restrictions on ClinicalTrials.gov are reasonable and consistent with Good Publication Practice 2 (GPP2). However, some restrictions, including publication bans, were found to be inconsistent or unclear.
Area of Science:
- Clinical Trials and Publication Ethics
- Regulatory Science in Clinical Research
Background:
- Sponsor-imposed publication restrictions in clinical trials registered on ClinicalTrials.gov are common, particularly in industry-sponsored research.
- Assessing the reasonableness of these restrictions against established guidelines like Good Publication Practice 2 (GPP2) is crucial for transparency and ethical research conduct.
Purpose of the Study:
- To evaluate the consistency of sponsor-imposed publication restrictions with Good Publication Practice 2 (GPP2) for clinical trials registered on ClinicalTrials.gov.
- To identify the reasons for inconsistencies between disclosed restrictions and GPP2 guidelines.
Main Methods:
- Electronic import and screening of ClinicalTrials.gov records for eligible trials (phase 2-4, interventional, recruitment closed, results available).
- Categorization of publication restrictions by two authors based on GPP2 consistency, with discrepancies resolved by consensus.
- Follow-up investigation of trials with insufficient information to identify additional undisclosed restrictions.
Main Results:
- Of 388 eligible trials, 80.7% disclosed restrictions, with 92.5% being industry-sponsored.
- A significant majority of disclosed restrictions (74.1%) were consistent with GPP2.
- Key reasons for inconsistency included insufficient information (48.1%), sponsor approval requirements (35.8%), text changes (8.6%), and publication bans (7.4%).
Conclusions:
- While many sponsor publication restrictions are reasonable and align with GPP2, a notable portion lacks clarity or constitutes outright bans, affecting participant consent.
- Sponsors must ensure clear and appropriate disclosure of all publication restrictions.
- Informed consent processes should explicitly inform volunteers about any potential publication restrictions prior to trial participation.
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