National Library of Medicine’s (NLM) Request for Information on ClinicalTrials.gov Modernization
The National Health Council (NHC) appreciates the opportunity to comment on the National Library of Medicine’s (NLM) Request for Information on ClinicalTrials.gov modernization. Clinical trials are a vital part of the medical-product development process and often serve as the point of access to treatments that give people with chronic diseases and disabilities their best chance to treat their conditions. The NHC recognizes that ClinicalTrials.gov is a valuable resource to patients, providers, and sponsors, but improvement is much needed to ensure it serves that purpose. This is why we are pleased that NLM has requested information from the stakeholder community, and we urge the NLM to focus modernization efforts on making the tool more understandable and usable for patients.
Our comments focus on making sure ClinicalTrials.gov is designed in a way that supports our goal of ensuring that all Americans, particularly those with chronic diseases and disabilities, have access to the health care they need. We recognize that actively participating in clinical trials can serve as the best health care option for many of the patients we represent, and we want to ensure that the restructure of the site enhances patients’ ability to understand the information about clinical trial availability to ensure patients and families make the best decisions possible.
Patient Engagement in Development and Oversight of ClinicalTrials.gov
This opportunity to provide input into the modernization of ClinicalTrials.gov is a positive first step in engaging patients, caregivers, providers, and advocates in ensuring the site serves as a beneficial tool for patients. However, there is a need for ongoing, dynamic input from patients and caregivers before, during, and after the redesign to make sure the modernization is truly effective for patients in the long term. To ensure that the site will serve as a useful and effective tool for patients, the NHC strongly recommends that the NLM create an advisory group of patients, caregivers, and providers.
Usability of ClinicalTrials.gov
The formation of ClinicalTrials.gov is based in the Food and Drug Administration Modernization Act of 1997 (FDAMA). Section 113 of FDAMA3 states that information on ClinicalTrials.gov “shall be in a form that can be readily understood by members of the public.” The NHC urges the NLM to continue working to ensure that information on ClinicalTrials.gov is presented using patient-friendly language.