Published September 4, 2019
ClinicalTrials.gov registration requirements
Planning and carrying out clinical research presents investigators with multiple hurdles. For some researchers, the biggest obstacle arises not in the lab, but at the keyboard, when they are required to register their studies and report their findings in a national data bank.
Registering and reporting their protocols and results can be a confusing and time-consuming process. Adding to the challenge is the fact that requirements are constantly evolving, and vary from agency to agency.
“Over the past couple of years, the regulations have changed and more studies than ever before need to be registered in ClinicalTrials.gov,” said Lynn Jagodzinski, Clinical Research Regulatory Administrator at University at Buffalo’s Clinical and Translational Science Institute. Her role is to assist investigators to navigate the regulations and online forms to ensure that all research conducted at the university complies with federal regulations.
“This registration is essential to get your study results published in a reputable peer reviewed journal, and you cannot register retroactively,” points out Sanjay Sethi, MD, Director of the Clinical Research Office at UB.
According to Jagodzinski, ClinicalTrials.gov is a registry and results database of federally and privately supported clinical trials conducted domestically and around the world. It is maintained by the National Library of Medicine of the National Institutes of Health.
The database was first mandated in 1997, and was expanded in 2007. The final regulations became effective on January 18, 2017, when all applicable clinical trials were required to be registered before they begin and have results submitted no later than one year after the study’s completion date. Failure to report brings the risk of fines for the investigator, the sponsor and the institution, and could result in the suspension or termination of the research. It could also prevent the study’s findings from being published in medical journals.
Information available on registry
The importance of a central data bank for study results is straight forward. The database catalogs study procedures before, during and after the trial and details any adverse events that may have arisen. Currently, the databank includes documentation on more than 314,500 studies from 50 states and 209 countries.
ClinicalTrials.gov helps potential research participants find trials for which to volunteer, enhances the design of clinical trials and prevents duplication of unsuccessful or unsafe studies, Jagodzinski said. Collected information guarantees that the database provides the most up-to-date evidence, improves clinical research practice and enhances the public’s trust in clinical research studies, she added. “It is a great resource if you are planning a study to see what is going on,” she notes.
“This registry has brought much needed transparency to the clinical trials process,” Sethi said. In addition, he said, it is an excellent recruitment tool.
The downside is that regulations about registering at ClinicalTrials.gov are not standard. The Food and Drug Administration, the National Institutes of Health and the International Committee of Medical and Journal Editors each has different standards and requirements for filing. Other, smaller agencies, for example the Centers for Medicare and Medicaid Services and the National Cancer Institute, have different requirements. Filling out all the appropriate forms in the required formats can take up to 40 hours, Jagodzinski said.
CTSI assistance with process
For investigators unsure about whether their study needs to be registered or how to complete the various forms, Jagodzinski can provide assistance. The first step, she says, is to complete registration documents before the study begins. ClinicalTrials.gov establishes one account for each research facility, and all investigators from that institution, such as UB, are designated users of this single account, named SUNYBuffalo, in UB’s case. Jagodzinski and others in the Clinical Research Office can answer investigators' questions and assist them with the process, she said. For more information on registering studies in ClinicalTrials.gov including FAQs, a "ClinicalTrials.gov Registration Guide" is available on the CTSI website for investigators and their research teams.
According to the most recent data on fdaaa.trialstracker.net, which compiles a listing of registered and reported research, only 67 percent of results of clinical trials have been publicly reported. Since doctors and patients use this data to determine appropriate courses of treatment, withholding results poses a risk to patients with life threatening diseases or conditions.
“People give their time and their bodies to research studies,” Jagodzinski said. “They should have access to the data.”
For more information about ClinicalTrials.gov, contact Jagodzinski at firstname.lastname@example.org, or call 888-4843.