Skip to main content

Advertisement

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]