Skip to main content

Table 1 Challenges and recommendations for promoting access to full trial protocols

From: Promoting public access to clinical trial protocols: challenges and recommendations

Challenge

Recommendation

Adequate incentives

Academic institutions and funders should implement research assessment indicators that give explicit credit to investigators who share protocols for their ongoing and completed trials

Comprehensive adherence mechanisms

Journal editors, regulators, sponsors, and funders should implement and enforce policies requiring public sharing of protocols for all trials within their remit

Prospective access to the original protocol

The original protocol version receiving ethics approval should be shared or placed in a lockbox prior to participant enrolment, to be made available at the time of results reporting along with the final protocol version listing any amendments

Universal venue for sharing protocols

Trial registries and journals should build capacity to become the standard repositories for housing and publishing of the original and final protocols online

Complete protocol content

Trial protocols should address key elements defined in the SPIRIT (Standard Protocol Items: Recommendations for Interventional Trials) guidance [2, 67]