Abstract
ClinicalTrials.gov was started with the intention to create a consumer-friendly database for patients and others in search of information on clinical trials. However, there is no research on whether the content of ClinicalTrials.gov aligns with patient preferences. The TransCelerate Clinical Research Access & Information Exchange Initiative convened patient advisory boards and conducted a global online survey (N = 1070) to determine patient preferences when searching for clinical trials for participation. Patient feedback and ClinicalTrials.gov guidance documents were used to construct instruments to assess patient focus and guidance adherence of the Brief Title (a short lay title of the clinical trial) and Brief Summary (a high-level summary of study features) data fields in a representative sample (N = 346) of ClinicalTrials.gov records of interventional trials. When searching for clinical trials, survey participants rated condition (66.4%), trial location (57.0%), trial dates (52.9%), age and gender (48.6%), and health measurements (i.e., what the study measures) (45.5%) as the most important items. When presented with a list of trials from an initial search, participants saw condition, brief summary, study drug name, and brief title as the most helpful items. In a Brief Title, they wanted condition, health measurements, participant age, and study drug name. For Brief Summaries, participants preferred additional information on treatment duration, condition, study goal, health measurements, and frequency of visits. The assessment of patient focus in a representative sample of current ClinicalTrials.gov records showed that patient focus was underdeveloped as study records achieved only 52% (brief titles) and 50% (brief summaries) of the best possible score. The analysis of adherence to ClinicalTrials.gov guidance showed better scores (brief titles 69%, brief summaries 66%). We identified key information elements for registry users when evaluating clinical trials for participation. We found that aspects of patient focus are not common in current ClinicalTrials.gov entries. To support more user-friendly study records, we developed a tool to assess the quality of the plain language fields in study records prior to submission.
Highlights
From the outset, the key purpose of ClinicalTrials.gov was to make information on clinical trials available to the public, to “individuals with serious or life-threatening diseases or conditions, to other members of the public, to health care providers, and to researchers” [1]
Based on feedback from Patient Advisory Board (PAB) and the online survey, we investigated the status of two data fields of current ClinicalTrials.gov records for patient focus and adherence to guidelines
We focused on brief title and brief summary because of their prominence in the ClinicalTrials.gov search result display, their importance for patients and members of the public, and the fact that these data fields are amenable to improvement because they permit text entries by the sponsor
Summary
The key purpose of ClinicalTrials.gov was to make information on clinical trials available to the public, to “individuals with serious or life-threatening diseases or conditions, to other members of the public, to health care providers, and to researchers” [1]. Hosted by the National Library of Medicine, ClinicalTrials.gov was to be a “consumer-friendly” database that provides easy access to information about clinical trials for patients and families and members of the public [2]. In 2007, the FDAAA widened the scope of ClinicalTrials.gov but retained the original purpose. The mandatory registration of clinical trials was complemented with the requirement to make trial results available [3, 4]. As the most comprehensive clinical trial database, ClinicalTrials.gov is the key source for many other registries around the globe
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