Taskforce launches website to help universities to register and report clinical trials
A Taskforce that brings together staff from 120 universities, academic medical centers, hospitals, and non-profit organizations across the United States has launched a new website to help institutions to register clinical trials and post their results onto the world’s largest clinical trial registry, Clinicaltrials.gov.
Many leading U.S. universities have significantly improved their regulatory compliance in recent years, but numerous others still fail to post clinical trial results, in violation of federal transparency legislation and WHO best practices.
No comparable initiative exists in Europe, even though European universities typically perform far worse than their U.S. counterparts. On the EU trial registry, results are missing for nearly 80% of the roughly 3,200 completed trials conducted by non-industry sponsors. While U.S. universities usually only have to manage their records on Clinicaltrials.gov, universities in Europe often have records spread across three or more different registries, each with its own rules and user interfaces.
The mission of the Clinical Trials Registration and Results Reporting Taskforce is to help its members to understand relevant rules and regulations, identify best practices in registry management, develop tools, and exchange experiences.
Over 350 individuals at 120 U.S. institutions and organizations who regularly register and post aggregate results data onto Clinicaltrials.gov have already joined.
Map of U.S. institutions with Taskforce members

“These people are the linchpin in the system,” Taskforce member Dr Evan Mayo-Wilson told TranspariMED, referring to so-called PRS Administrators, the individuals who manage universities’ Clinicaltrials.gov organizational accounts and post registration and results data onto the registry.
Within U.S. universities, Research Coordinators and other study staff are usually responsible for entering data onto the registry. They closely collaborate with the investigators conducting clinical trials to ensure that the data submitted meet registry requirements.
“Investigators need to work with PRS Administrators to understand the registry’s intricate rules,” Mayo-Wilson explained. And those rules can create formidable hurdles for the investigators, he warned. “For example, according to the registry’s definition, an outcome measure consists of four distinct elements, but there is just one data field labelled ‘outcomes’. PRS Administrators understand how this system works and can help investigators register and report their trials quickly and accurately.”
Over 130 members regularly attend monthly calls, where they receive updates on new regulations and guidance, receive updates from ClinicalTrials.gov staff who participate in calls, and hear from several ongoing subcommittees that work together to develop tools. The Taskforce also maintains a listserv where members can ask questions and share experiences.
Membership is free, but all members are expected to actively contribute to the network. Some resources, including a collection of sample university policies, have been made publicly available on the new website, but others are restricted to members only. More material will be added over time. The Taskforce continues to welcome new members.
To support the Taskforce’s mission, Mayo-Wilson has just completed a qualitative survey to better understand the challenges PRS Administrators face. Strong support from the top seems to be a key success factor. “A lot depends on where the Dean stands,” Mayo-Wilson has concluded. “If the Dean wants it to get done, it gets done. In some universities, if a principal investigator falls behind on posting results, they’ll get a call from the Dean. And nobody wants that to happen.”
An earlier survey led by Mayo-Wilson had found that less than half of U.S. universities had a policy on clinical trial registration. The full survey paper forms a solid baseline for future research, with a second survey currently underway.
The Taskforce, which has already been active for several years, is currently led by Anthony Keyes of Johns Hopkins University and Sarah White of the Multi-Regional Clinical Trials Center at Brigham and Women’s Hospital and Harvard.
Members of the Taskforce receive no external funding for their participation. The Taskforce receives administrative support from The Harvard Clinical and Translational Science Center (Harvard Catalyst). A special project of the Taskforce led by Mayo-Wilson is looking at increasing compliance with clinical trial reporting requirements. This project is funded by grants from the US Food and Drug Administration, the National Center for Research Resources, and the National Center for Advancing Translational Sciences.
TranspariMED hopes that this excellent (and ultra low cost) inititiative will be replicated in other countries and regions.