Many Organizations Not Meeting Trial Reporting Requirements

Only 19% of organizations use computer software to monitor compliance with Final Rule
Only 19% of organizations use computer software to monitor compliance with Final Rule

HealthDay News — Many organizations are not meeting the trial registration and results reporting requirements clarified by "The Final Rule," which had a compliance date of April 18, 2017, according to a study published online May 1 in BMC Medicine.

Evan Mayo-Wilson, DPhil, from the Johns Hopkins University Bloomberg School of Public Health in Baltimore, and colleagues surveyed Protocol Registration and Results System (PRS) accounts classified by ClinicalTrials.gov as a University/Organization. One PRS administrator completed the survey for each organization account. 

Related Articles

The researchers found that in August 2016, there were 47,701 records for 783 eligible organization accounts. A total of 366 participating organizations (47%) included 85% of the records. Clinical and Translational Science Award holders, cancer centers, and large organizations were more likely to participate compared with other organizations. Forty-three and 35% of accounts had a registration or results reporting policy. Of those with policies, 11 and 35% reported that trials must be registered before granting of institutional review board approval or before beginning enrollment, respectively. Nineteen percent of organizations used computer software to monitor compliance; an investigator was penalized for non-compliance by one organization. The median number of full-time-equivalent staff was 0.08 among the 78% of accounts reporting that they allocate staff to fulfill ClinicalTrials.gov registration and reporting requirements.

"Most organizations appear to be unprepared to meet the new requirements," the authors write.

Abstract/Full Text