- Full participation across all stakeholders — clinical trial sponsors, sites, investigators, patients and their healthcare providers
- Information is fully used to improve the overall quality, design and development process. We protect patients through shared, proactive safety science
- Improving the execution of research and development through greater harmonization with the potential to conduct collaborative trials
Newest Resources and Company Milestones
- TransCelerate announced the expansion of access to COVID-19-related patient-level clinical data sharing via DataCelerate® to non-member companies and biopharmaceutical research agencies that meet certain qualifications. More information on the criteria is available here. This announcement quickly follows a decision to utilize the DataCelerate® platform to share control arm data from ongoing and planned COVID-19 clinical studies.
- Peter Ronco, Head of Global Development at Janssen R&D, was nominated by Johnson & Johnson to be its new representative to the TransCelerate Board of Directors.
- TransCelerate attended the virtual DIA 2020 Global Annual Meeting and presented 15 sessions throughout the four-day conference in June. For a full recap of the event, read this post.
- TransCelerate held two virtual webinar panels on “Exploring How TransCelerate Solutions Can Enable Clinical Trial Continuity.” The panel explored how existing TransCelerate solutions can support Clinical Trial Continuity during times of disruption. View the full sessions here
Pulse On Progress Updates
Improve the Patient & Site Experience
Improve the patient and site experience by decreasing burden, enabling a better-informed patient and improving clinical research awareness, participation & engagement.
- The Clinical Research Access & Information Exchange (CRAIE) Initiative team published a paper in PLOS ONE, “Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields.” The paper describes the results of a global survey on the information preferences of patients when looking to participate in a trial and provides an analysis of current ClinicalTrials.gov entries in regard to their patient friendliness and adherence to guidelines. The paper concludes that sponsors should make ClinicalTrials.gov entries more user friendly to facilitate patient access to clinical studies.
- The CRAIE Initiative team also published an infographic, “What Patients Want to See in Clinical Trial Registries.” The infographic, based on a global patient survey with 1,070 responses, details what information is helpful when patients begin their search for clinical trials in a registry and what information patients find important.
Information Sharing & Harmonization
Enable the industry to move toward greater harmonization of process and facilitate the sharing of information amongst industry stakeholders to enable the industry to capture, optimize and experience efficiencies.
- The Clinical Content and Reuse (CC&R) Initiative released a new solution, the Clinical Study Report (CSR) Considerations for Studies Disrupted by the COVID-19 Pandemic. This document was created by clinical scientists, pharmacovigilance experts, data scientists, and other professionals to identify the important topics that clinical researchers and research sponsors may consider as they adapt their studies and clinical study reports due to disruptions caused by COVID-19. At this time, no further updates to this content are planned, though TransCelerate will be seeking further input from experts and regulators to guide CSRs for studies disrupted by COVID-19.
- The Digital Data Flow (DDF) workstream conducted a virtual Hackathon to evaluate feasibility for the study design component of the DDF Vision. The DDF Hackathon attracted 175 participants across 15 entries to provide innovative solutions to meet user needs described in 15 user stories, which aim to help transform the workflow from document-based to a content driven-data, design, workflow, and management environment. All 15 entrants’ prototypes provided valuable insight to the challenge of study start up digitization and process automation. The judging panel ultimately selected three entries as Distinguished Submissions: Microsoft & InteliNotion, Nurocor, and Trials.ai.
- The Placebo and Standard of Care Initiative is rebranding to a new name: Historical Trial Data Sharing (HTD) (Controls). This name change has been made so the initiative title better reflects the team’s work: enabling the sharing of historical trial data to maximize the value of clinical data collected in the control arms of clinical trials. Though the name is changing, the team’s valuable work continues.
Enhance Sponsor Efficiencies
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.
- Melissa Suprin and the Quality Management System (QMS) Initiative team were the recipients of the 2020 DIA Global Inspire Award for Author of the Year. This award recognizes the author or whose article made the greatest impact on readership, as judged by the most downloaded article published in the DIA peer-reviewed journal, Therapeutic Innovation & Regulatory Science (TIRS), in the preceding year. The article, “Quality Risk Management Framework: Guidance for Successful Implementation of Risk Management in Clinical Development,” was downloaded 4,349 times in 2019.
Enhance Drug Safety
Facilitate solutions that address a common set of challenges in drug safety surveillance such as engaging the public, collaborating with regulators, incorporating data and analytics, developing model approaches, and assessing the impact of efforts.
- The Intelligent Automation Opportunities (IAO) in Pharmacovigilance Initiative added the 2020 Technology Matrixto their assets page. The 2020 Technology Matrix provides information regarding the types of intelligent automation technologies available in pharmacovigilance and maps what technologies have been implemented in connection with specific Individual Case Safety Report processes.
- The Interpretations of Pharmacovigilance Guidances & Regulations (IGR-PV) and the Interpretations of Clinical Guidances & Regulations (IGR) Initiatives launched their new asset pages. Each guidance or regulation now has its own page describing the topic and lists all associated assets in a single linkable location. The IGR PV and IGR Clinical assets were developed as part of the mission to share expertise to more efficiently and effectively meet the intent of what are historically ambiguous regulations, guidances and operational expectations around the world. Secondarily, the initiatives take opportunities to raise Health Authority awareness of the real-world impact of ambiguous regulations and guidelines.
- The Advancing Safety Analytics (ASA) Initiative published a paper, “Signal Management: Current Landscape and Considerations for Best Practices.” This paper reviews the current landscape of signal management and proposes a simplified, end-to-end framework while highlighting some best practices. The ASA team collaborated to understand end-to-end signal management and the unique value or contribution of publicly available data sources.
Key Considerations for Clinical Study Reports for Studies Impacted by COVID-19
We spoke with Elizabeth Bygate, former Director at GlaxoSmithKline, about adapting clinical study reports to reflect disruption that may have occurred due to COVID-19.
In recent months, the unprecedented COVID-19 pandemic has had a significant impact on clinical research and development, especially for active treatment studies. From increased difficulty enrolling participants in studies and collecting measurements to reduced availability of supplies and potential new biases in the data, clinical research is dealing with significant changes and challenges, all while trying to ensure that the data and scientific integrity are upheld.
Although there have been tribulations, encouraging moments of collaboration have also emerged. “Positively, the pharmaceutical industry has been coming together in this difficult environment to support patients, clinical researchers, research sponsors and other important stakeholders,” notes Elizabeth. For example, industry regulators like the Food and Drug Administration have released guidance for researchers, focused on the health and safety of clinical trial participants.
TransCelerate’s Clinical Content and Reuse (CC&R) Initiative, which aims to enhance clinical trial processes by facilitating content reuse across clinical trial documents, has also been active in supporting the industry’s pandemic response and prioritizing patient safety during this period. In fact, a new team was recently created to focus on identifying how clinical study reports can be adapted to reflect any disruption that may have occurred due to COVID-19. Clinical study reports are critical documents that describe the methodology and results of a clinical trial in drug development.
Leveraging TransCelerate’s impressive global network, the CC&R team quickly assembled a group of more than 50 experts to consider and identify the most important considerations for clinical researchers and research sponsors related to writing clinical study reports for studies that have been impacted by COVID-19. The team is highly familiar with regulatory guidance on clinical study reports and update the tools and templates annually, making them well-positioned to support clinical researchers and research sponsors. The team has also already established strong relationships with global pharmaceutical regulators and other industry consortia, allowing for rapid adjustment and feedback on the process and findings. Additionally, the diverse make-up of the team was beneficial, featuring medical writers, statisticians, data scientists, safety experts and more from 10 countries and 15 TransCelerate Member Companies.
To begin this work, the CC&R team identified considerations in a few domains that clinical researchers and research sponsors could consider when writing their clinical study reports for trials that may have been disrupted by COVID-19. To name a few, researchers could start by identifying and explaining if and how COVID-19 impacted their trial, including any deviations in protocol. Researchers could also consider how the pandemic may have affected their trial data, which could include the site being closed temporarily during COVID-19, the pandemic being in different stages and different study sites or certain patients being at greater risk of contracting COVID-19 and therefore not willing to travel to the site.
However, not all considerations will apply to all trials. “While some trials may have failed due to the COVID-19 disruption, others may have been impacted only minimally. The circumstances of each trial must be evaluated by the sponsor to determine the extent of required reporting,” mentions Elizabeth.
Armed with this comprehensive analysis, the CSR Considerations for Studies Disrupted by the COVID-19 Pandemic tool was created, which shares several important lessons related to managing the execution of clinical trial logistics while prioritizing participant safety. Specifically, the tool includes a set of proposed guiding principles, followed by two content related sections: ‘summary of impact’ with considerations on the chronology of events and adjustments and mitigations for the trial, and ‘scientific validity of the trial’ with considerations on statistical issues and safety reporting.
Overall, this resource is intended to assist sponsors as they plan for Clinical Study Report (CSR) documentation of the effect of the COVID-19 pandemic on a clinical trial. Importantly, this document provides prompts for consideration, but should not be treated as a checklist or set of minimum requirements for reporting. It is intended to be used as a starting point and discussion of trial-specific situations or nuances may be appropriate as they arise.
When looking ahead, Elizabeth notes that clinical research and clinical study reports may change forever due to COVID-19. “I anticipate that trials will become increasingly decentralized and/or virtual, incorporating remote monitoring, home visits and telemedicine into the process. We are also looking forward to broader use of tools like the TransCelerate templates, eSource and other source data verification to promote high quality clinical trials in all settings,” she states.
The impressive effort by the TransCelerate CC&R team to quickly deliver an impactful set of considerations and sample text to the pharmaceutical industry is a reminder about the power of the TransCelerate network, its experts and member companies. It also speaks to the significance of collaboration and cooperation across the clinical development ecosystem, especially during times of uncertainty. “And while clinical research may change permanently as a result of COVID-19, it presents an exciting opportunity to continue to work with our TransCelerate members and the broader pharmaceutical and research communities to ensure that change is for the better,” Elizabeth concludes.
The Patient Technology Initiative
On behalf of TransCelerate’s Clinical Research Access & Information Exchange Initiative team, we talked with Dr. Thomas M. Schindler, Head of the Innovation Medical Writing Group at Boehringer Ingelheim Pharma GmbH & Co. KG, to learn more about the team’s recent paper.
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% of the general public feels it is important to be aware of research conducted within their own local communities.
To help patients and families find information about clinical trials, the National Institutes of Health (NIH) instigated ClinicalTrials.gov. Although timeliness and comprehensiveness of clinical trial registration and the results posted by sponsors have 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’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.
Q: Please describe the intent and purpose of ClinicalTrials.gov.
A: 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, ClinicalTrials.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.
Q: What gaps still remain when it comes to improving clinical trial participation and how is the CRAIE Initiative helping close those gaps?
A: The timeliness and comprehensiveness of clinical trial registration and results posting by sponsors has received interest and been well-studied. However, research on whether patients and registry users find the information on ClinicalTrials.gov to be useful and appropriate has not been performed yet.
Considering this, the CRAIE Initiative was determined to investigate the barriers preventing patients and others from finding available clinical trials. Our recently published paper, “Patient preferences when searching for clinical trials and adherence of study records to ClinicalTrials.gov guidance in key registry data fields,” 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.
Q: In your recent paper, how was the research on patient preferences in clinical trials conducted?
A: To develop an initial insight into patient preferences when using trial registries to identify suitable trials, our 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 regarding their helpfulness when searching for and evaluating clinical trials in a registry for participation.
Equipped with the PAB and online survey results, we 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 ClinicalTrials.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.
Q: Tell us about the main results of this analysis. What findings stood out?
A: 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, which can be viewed in more detail in our CRAIE Infographic. When beginning their search for clinical trials in a registry, participants rated condition (66.4%), trial location (57%) and trial start and end dates (52.9%) as the most helpful items.
For brief summaries, the treatment duration (56%), a more detailed condition/disease description (54.3%), and the study goal (52%) were all reported as being the most beneficial factors. On the other hand, for brief title, condition was the most important information item (79%) 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% (brief titles) and 50% (brief summaries) of the best possible score. The analysis of adherence to ClinicalTrials.gov guidance showed better scores, with 69% for brief titles and 66% for brief summaries.
While our findings indicated that 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%) 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.
Q: From your perspective, what do these findings mean for enhancing the future of patient participation in clinical research studies?
A: 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.
Mark Your Calendars
TransCelerate leaders and Member Companies are invited to participate and present at many biopharmaceutical research industry conferences and meetings across the globe to provide a perspective on industry challenges and clinical trial issues. Take a peek at a few places we will be presenting early next year. For detailed information on speaker presentations, visit the events page on the TransCelerate website.