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Project Delays | Part 1: ClinicalTrials.gov Enhances Research and Keeps Projects on Track

For the next three months the Spotlight considers the topic of project delays in funded research. What pitfalls, anticipated or unexpected, can contribute to or cause delays or disruptions? What strategies/tips/techniques can be used to either offset or overcome delays, unexpected or inevitable, for an approved project/grant/study? This series begins with a look at ClinicalTrials.gov and how its effective use can complement a research project and contribute to its steady progression toward completion. Three research administrators with expertise with this digital platform offer insights on how this resource works at their respective institutions.

ClinicalTrials.gov is a widely recognized and valuable resource for researchers, healthcare professionals, and patients seeking information about human subject participant trials. As the comprehensive online database maintained by the National Institutes of Health (NIH), ClinicalTrials.gov provides access to a vast array of privately and publicly funded clinical studies conducted around the world. 

Every institution has a different system for handling research involving clinical trials and their associated internal regulatory compliance approvals. To highlight the significance of ClinicalTrials.gov’s impact on the research community, three research administrators who work closely with this platform discuss their experiences and offer insights on promoting clinical studies with a focus on alleviating potential project delays. These practitioners are: Jesse Reynolds, biostatistician at the Yale Center for Analytical Sciences  and Director of Yale University’s ClinicalTrials.gov Team; Dr. Carrie Dykes, Director of Research Services at the University of Rochester Medical Center (URMC); and Lauren Odynocki, Senior Human Research Compliance Specialist at Weill Cornell Medicine (WCM), New York.

 At Yale University, Reynolds notes that all clinical trials are operated through a centralized system; when a Principal Investigator (PI) holds an Investigational New Drug (IND) or Investigational Device Exemption (IDE), the institution is responsible for registering the study. The PI is designated as the responsible party unless the study is being registered for compliance or publication requirements (NIH compliance or International Committee of Medical Journal Editors (ICMJE) guidelines). In these instances, the institution assumes the role of the responsible party and sponsor.

At URMC, the PI holds the responsibility for the study. Dr. Dykes stated that the investigator has the responsibility to determine if the study requires registration, and if so, to register it accurately and report the necessary results. Creation of clinical trials accounts is managed by the administration, which also submits the summary of results on behalf of the PIs. 

WCM has a robust structure in place for its ClinicalTrials.gov program. This includes formal institutional policies, use of the Institutional Review Board (IRB) to make ClinicalTrials.gov regulatory determinations, and extensive ClinicalTrials.gov training and on-demand help sessions for PIs and study teams. In addition, WCM is listed as responsible party in ClinicalTrials.gov so Odynocki is able to conduct a thorough internal quality control review. 

Effective use of the ClinicalTrials.gov platform plays a pivotal role in facilitating efficient trial management, which in turn minimizes project delays. Although IRB approval is not required before registering a study, the registration process itself is where significant delays can occur. All the experts provide extensive support and training to fill in the blanks, by helping researchers understand ClinicalTrials.gov’s purpose and the regulatory definitions that direct what information gets placed into this resource. Odynocki also crosschecks investigators’ work with what the IRB has on file, what WCM’s Clinical Trial Management System lists, sometimes what is stated in the grant, and also works with study teams to edit for accuracy. This helps studies start and proceed with compliance. 

When discrepancies or issues arise during the registration process, Reynolds takes the responsibility to handle and resolve them efficiently. While there is no mandatory review of records before submission, Dr. Dykes assists the PI with any concerns that may arise. As Odynocki noted, “Regarding challenging [regulatory] situations, fortunately most investigators are more inquisitive than anything else about what they need to do to comply with the requirements.” For the few investigators who find themselves caught off guard to the point of frustration, Odynocki and the other experts concur that they take the lead in helping researchers understand the reality of the current regulatory climate. 

In summary, ClinicalTrials.gov stands as a testament to the research community's commitment to provide transparency, collaboration, and the betterment of healthcare, despite project delay setbacks. Clinical trials provide essential data and insights that contribute to scientific advancements, improved patient care, and the development of new treatments and therapies. By leveraging its vast resources and functionalities, researchers, healthcare professionals, and patients can contribute to the advancement of medical knowledge and ultimately improve the lives of countless individuals.

Authored by 
Rani Muthukrishnan, PhD, Director of Research Compliance, Texas A&M University, San Antonio
Anita Trupiano, Program Development Analyst, ClinicalTrials.gov PRS Administration Team, Cancer Institute of New Jersey Rutgers