Access to unpublished protocols and statistical analysis plans of randomised trials

Area of Science:

• Clinical Trials
• Research Transparency
• Scientific Publishing

Background:

• Protocols and Statistical Analysis Plans (SAPs) enhance randomized trial transparency.
• These crucial documents are often not publicly available.
• This study investigated investigator willingness to share unavailable documents.

Purpose of the Study:

• To determine the rate at which study investigators share unavailable protocols or SAPs upon request.
• To assess the feasibility of obtaining these documents via direct author contact.

Main Methods:

• Two cohorts of randomized trials were analyzed (high-impact journals and PubMed-indexed journals).
• Corresponding authors of trials lacking publicly available protocols/SAPs were emailed up to four times.
• Response rates and document sharing were recorded.

Main Results:

• 48% of 201 trials lacked publicly available protocols or SAPs.
• Only 8% of authors shared any trial documentation upon request.
• Direct requests increased protocol availability by only 3%.

Conclusions:

• Most investigators are unwilling to share unpublished protocols or SAPs directly.
• Current methods are insufficient for ensuring access to essential trial documents.
• New strategies are required to enhance the transparency of randomized trials.