By Thomas M. Schindler, Frank Grieger, Anna Zak, Ramona Rorig, Kavya Chowdary Konka, Anna Ellsworth, Christopher Pfitzer, Keir Hodge, and Christine Crandall, on behalf of TransCelerate’s Clinical Research Access & Information Exchange (CRAIE) Initiative
Bringing innovative therapies to patients relies on robust clinical trial participation, which begins with awareness of and access to available clinical trial opportunities. The 2017 Center for Information and Study on Clinical Research Participation (CISCRP) Perceptions and Insights Study reported that 84 percent of the general public feels it is important to be aware of research conducted within their own local communities. The study also found that only 40 percent of patients feel confident in finding an appropriate clinical trial on their own, suggesting the critical need to improve awareness of and access to clinical studies among eligible populations.
To help patients and families find information about clinical trials, the National Institutes of Health (NIH) instigated ClinicalTrials.gov. From the outset, the key purpose of ClinicalTrials.gov was to be a consumer-friendly database that made information on clinical trials publicly available to “individuals with serious or life-threatening diseases or conditions, and to other members of the public, to health care providers, and to researchers.” This objective has been maintained through all subsequent updates to the clinical trial registry.
Currently, ClinicalsTrials.gov offers information on approximately 314,000 trials in 209 countries and has close to 145,000 unique visitors daily. As the most comprehensive clinical trial registry in the world, it also acts as the central information source for many other registries around the globe. The information about clinical trials on the site is presented in a structured way — leveraging different tabs and tabular data displays — and sponsors can enter information into either open text fields or choose from predefined drop-down menus of suggested answers. There is also extensive guidance from ClinicalTrials.gov on the way sponsors should populate the various data fields to avoid confusion.
Although timeliness and comprehensiveness of clinical trial registration and the results posted by sponsors received a lot of attention, investigations on the adequacy of the information presented on ClinicalTrials.gov from a patient and clinical trial registry perspective had not yet been conducted.
In response, TransCelerate BioPharma’s Clinical Research Access & Information Exchange (CRAIE) Initiative, which aims to improve access to information about clinical research and clinical trial options, set out to investigate the barriers preventing patients and others from finding available clinical trials. Our recently published paper describes the information items that patients feel they need to be able to obtain from ClinicalTrials.gov and other public registries to make informed decisions about their potential trial participation.
To develop an initial insight into patient preferences when using trial registries to identify suitable trials, TransCelerate’s CRAIE team commissioned CISCRP to organize patient advisory boards (PABs) in June and November of 2018. The patients selected had all either been clinical trial participants, had a chronic condition, or were patient advocates. Based on the feedback from the PAB, a 20-question survey was fielded, where 1,070 participants around the globe ranked or selected various categories of information in regard to their helpfulness when searching for and evaluating clinical trials in a registry for participation.
Equipped with the PAB and online survey results, the CRAIE Initiative team developed assessment instruments to analyze the quality of the data — measured by “patient focus” and “guidance adherence” parameters — submitted to ClinicalTrials.gov for two data fields: the “brief title” (a short lay title of the clinical trial) and the “brief summary” (a high-level overview of study fields). We concentrated on these elements because of their importance for patients and the public, the guidance provided by ClinicalTials.gov to include patient-friendly language in these fields, and their prominence in the ClinicalTrials.gov search result. The overall objective was and remains to meaningfully improve the quality of data supplied by sponsors, which the NIH indicated was a prerequisite needed from industry before material improvements to the ClinicalTrials.gov platform could be considered.
According to responses received from the PAB meetings, participants identified “condition,” or the disease being studied, as a vital item when searching for a clinical trial because this determines whether the trial is relevant to them. Location of the investigational site and information in a brief summary were also key elements for survey participants. In addition, people expressed appreciation of trial descriptions that explained the level of commitment expected for participation, such as the number of visits, the planned treatment duration for individual patients, and the health measurements (i.e., what the study measures). They also stressed the importance of brief summaries to provide information in complete grammatical sentences using language that is easy to understand.
Respondents to the global survey shared similar viewpoints. When beginning their search for clinical trials in a registry, participants rated condition (66.4 percent), trial location (57 percent), trial start and end dates (52.9 percent), participant age and gender (48.6 percent), and health measurements (45.5 percent) as the most helpful items.
For brief summaries, the treatment duration (56 percent), a more detailed condition/disease description (54 percent), and the study goal (52 percent) were all reported as being the most beneficial factors. On the other hand, for brief title, condition was the most important information item (79 percent) for the identification of a suitable study. However, due to space limitations and the requirement to use plain language, the condition can only be expressed in broader terms in brief titles. For example, a brief title of a study in patients with stage IIIB/IV non-small lung cancer may only mention the term “lung cancer” in the brief title and provide the more detailed description of the condition in the brief summary.
Furthermore, the assessment of data quality, as measured by “patient focus” and “guidance adherence” parameters, in a representative sample of current ClinicalTrials.gov records, showed that patient focus was underdeveloped, as study records achieved only 52 percent (brief titles) and 50 percent (brief summaries) of the best possible score. The analysis of adherence to ClinicalTrials.gov guidance showed better scores, with 69 percent for brief titles and 66 percent for brief summaries.
While adherence to ClinicalTrials.gov guidance is not optimal, the bigger issue is the widespread absence of patient focus in most brief titles and brief summaries. In our analysis, no brief title and only two brief summaries (0.6 percent) achieved the maximum assessment for patient focus. A reason for the apparent absence of a focus on patients in brief summaries could be that sponsors only consider trial registration in ClinicalTrials.gov as a legal requirement, rather than an opportunity to engage with patients and raise interest for their trials. The higher scores for adherence support this view.
Moving forward, improvements in patient focus for brief titles and brief summaries could be achieved by NIH making the information items identified in this research mandatory (i.e., condition, location, and trial dates) or by sponsors more pervasively including them in guidance documents. However, the improvement of guidance must be complemented by sponsors’ realization that ClinicalTrials.gov entries have the potential to adequately inform patients and the general public about clinical trials. More patient-focused brief titles and brief summaries may allow for improved decision-making on clinical trial participation. Positively, the CRAIE Initiative has created a Clinical Trial Registration Tool that will help sponsors assess their data quality of the brief title and brief summary so they can produce more patient-focused clinical trial submissions.
Ultimately, we are hopeful that our study will help stakeholders across the clinical research ecosystem to gain a stronger understanding about the patient information preferences in study records. We have the opportunity to act on these findings not only to improve the usefulness of ClinicalTrials.gov but also enhance the patient experience in current and future clinical trials.
About The Main Author:
Dr. Thomas M. Schindler heads the Innovation Medical Writing Group at Boehringer Ingelheim Pharma GmbH & Co. KG, which covers topics related to transparency, patient access to clinical information, and plain language communication. He has supported TransCelerate’s Clinical Research Access and Information Exchange Initiative for many years. He studied biology and linguistics in Germany and the U.K., obtained a Ph.D. in molecular physiology, and did postdoctoral research in the U.K. Thereafter, he became an editor of popular science. He turned to medical writing and has gained some 23 years of experience in both medical affairs and regulatory medical writing in senior leadership positions. He currently focuses on patient access to clinical trial data, plain language communication, and digital approaches to clinical documents.