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] |