Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields

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.


1) Periods
• Enter "1" for a "YES" if a period is absent at the end • Enter "0" for a "NO" if a period is present at the end 2) Abbreviations • Enter "1" for a "YES" if: • All abbreviations included are defined • No abbreviations are used • Enter "0" for a "NO" if: • An abbreviation is included but is not defined • Abbreviations are included but all are not defined

Content (5 areas)
3) Condition: Does the brief title indicate the heath condition(s) being assessed by the trial (e.g. diabetes, heart disease)?
• Enter "1" for a "YES" if: • The brief title makes any mention of the condition being studied.
• If the condition is abbreviated, regardless of whether the abbreviation is not defined or not. • Enter "0" for a "NO" if the condition is absent 4) Information on the participants: Does the brief title indicate that participants are required for the trial and, in a sense, humanize the brief title? (6 parts) 1. Use of the term 'Patient' • Enter "1" for a "YES" if 'Patient' is present • Enter "0" for a "NO" if 'Patient' is absent 2. Use of the term 'Participant' • Enter "1" for a "YES" if 'Participant' is present • Enter "0" for a "NO" if 'Participant' is absent 3. Use of the term 'Participant' • Enter "1" for a "YES" if 'Volunteer' is present • Enter "0" for a "NO" if 'Volunteer' is absent 4. Use of the term 'Volunteer • Enter "1" for a "YES" if 'Subject' is present S2 to Patient preferences and adherence to guidance in ClinicalTrials.gov study records • Enter "0" for a "NO" if 'Subject' is absent 5. Participant age • Enter "1" for a "YES" if age is present in either numerical range (e.g. over 50 years of age) or categorical (e.g. adult, pediatric) forms • Enter "0" for a "NO" if age is absent 6. Participant gender/sex • Enter "1" for a "YES" if gender/sex is present e.g. men, women, males, etc • Enter "0" for a "NO" if gender/sex is absent 5) Intervention(s): Does the brief title provide information on the intervention(s) being studied? If more than one drug is mentioned, then the assessment is limited to the study drug(s), not the comparator. (5 parts) 1. Intervention name • Enter "1" for a "YES" if ANY proprietary, scientific, generic or brand name of the study drug is present, even if abbreviated (e.g. BMC-986567, insulin) • Enter "0" for a "NO" if any intervention name is absent 2. Form of the interventional drug • Enter "1" for a "YES" if the form of the study drug is present • Examples of administration include: tablet, pill, capsule, patch, cream, ointment, injection • Enter "0" for a "NO" if the form of the study drug is absent 3. Route of administration • Enter "1" for a "YES" if how the study drug is administered is present • Examples of administration include: oral, topical, intravenous • Enter "0" for a "NO" if the route of study drug administration is absent 6) Health measurements: The health measurement[s] or observation[s] examined to determine the effect from the trial drug (e.g. the reduction in bad cholesterol, kg of weight loss). The language can be similar to the study objectives or primary outcome measures (see the additional columns of data field information on the spreadsheet).
• Enter "1" for a "YES" if any health measurements are present • Terms that are common to health measurements: reduction, correction, reversal, lower, increase, improve • Enter "0" for a "NO" if any health measurements are absent • Terms that may seem like health measurements but are not: safety, efficacy, evaluate 7) Technical study design terms: Technical study design terms describe the design/execution of a study. NIH discourages the use of technical study design terms in Brief Titles, so we are scoring titles without such terms as "1".