- 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
- We introduced a new Leadership Lens video series, showcasing TransCelerate leaders discussing the importance and impact of TransCelerate and its work. Watch the first two videos from the series, featuring CEO Dalvir Gill and Chair of the Board, TransCelerate and SVP, Global Head of Pharma Regulatory and Policy, Roche Michelle Rohrer.
- BioCelerate’s Common Templates for Nonclinical Studies team released its V1.0 Nonclinical Common Report Template, Approaches to Implementation in your Organization deck, and an initiative overview called Why Common Templates?. The NCRT is designed as a companion to the currently available Nonclinical Common Protocol Template and supports generating meaningful efficiencies in the reporting process.
- Additionally, BioCelerate launched a new website homepage. This redesign showcases BioCelerate’s latest news and solution launches in one easy-to-access view, allowing visitors to download solutions, learn more and read further about the various initiatives in a more simplified manner.
- We issued a press release formally announcing our latest initiatives: DataCelerate® COVID-19 Module, Modernizing Clinical Trial Conduct, Real World Data and Pharmacovigilance Agreements (PVAs) Optimization. These initiatives further our mission to collaborate across the global biopharmaceutical research and development community to identify, prioritize, and facilitate implementation of solutions designed to deliver new medicines to patients efficiently, effectively, and with high quality.
Pulse On Progress Updates
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 & Reuse (CC&R) Initiative launched its 2020 release, including an updated CC&R Initiative website and Solutions Page. Key changes include updates that provide more focus on how the Clinical Template Suite (CTS) and tools enable content reuse across the clinical development ecosystem, updates to template content in alignment with ICH E9 (R1), updates to eTemplates, and enhanced patient centricity and ClinicalTrials.gov registration, which was done in partnership with the Clinical Research Access Initiative.
- The DataCelerate® & Historical Trial Data (HTD) Sharing Initiatives launched a new DataCelerate module for sharing COVID-19 data. This module replaces an existing COVID-19 file share solution launched in April with several key improvements, and it is open to participating members of TransCelerate, as well as qualifying non-member biopharma and government biomedical research agencies. Participating companies may make anonymous requests for COVID-19 relevant studies from other participating companies directly through the DataCelerate platform. For more information, read our blog post: How the Pharmaceutical Community is Powering the Sharing and Reuse of Data.
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 Patient Experience Initiative released an infographic outlining why and how the Patient Protocol Engagement Toolkit (P-PET) and Study Participant Feedback Questionnaire (SPFQ) Toolkit were created with patient advisors and R&D experts. View the infographic here.
- The Patient Experience Initiative also released the Patient Protocol Engagement Toolkit translated to Japanese located under Solutions Available in Additional Languages.
- The Modernizing Clinical Trial Conduct Initiative and the Association for Clinical Research Organizations’ (ACRO) CRO Forum conducted a collaborative workshop to explore root cause, challenges and enablers of success for the use of modern methodologies in clinical research. The topics of the workshop included telemedicine, shipping, home health visits and local lab usage. To read more about the workshop and its findings, click here.
Enhance Sponsor Efficiencies
Facilitate the advancement of innovative healthcare and clinical research through improved technologies, advanced data collection systems and simplified processes.
- The Interpretation of Clinical Guidances & Regulations: GDPR Data Reuse topic team released a new solution and supporting materials, all focused on addressing the uncertainty surrounding the European Union’s General Data Protection Regulation (GDPR) with respect to data reuse. Read their solution, A Privacy Framework for Clinical Data Reuse: Secondary Data Use in the Pharmaceutical Industry, its supporting materials, and watch the overview video.
- The Interpretation of Clinical Guidances & Regulations: Quality Tolerance Limits (QTL) topic team released several solutions to help Sponsors experiencing challenges with interpreting and operationalizing QTLs, including a Quality Tolerance Limits Framework, infographic and Demystifying Quality Tolerance Limits Webinar. These solutions were developed in response to the E6 R2 guidelines published by ICH in 2016, which introduced risk-based approaches to quality management for clinical development, including the concept of Quality Tolerance Limits. To view all the team’s full list of solutions, visit its website.
- The Quality Management System (QMS) Initiative released an infographic highlighting examples where Member Companies found significant value implementing a Clinical QMS framework for clinical research.
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 in Pharmacovigilance Initiative launched a video for the Interactive ICSR and Automation Technology Tool (IATT). The solution depicts each process step within the Individual Case Safety Report (ICSR) process, and the video demonstrates how the tool can be used and adopted. Watch for an overview of what IAO is, information on the creation of the IATT and lastly, a step-by-step guide on how to navigate the interactive website features of the IATT.
- The TransCelerate Interpretation of Pharmacovigilance Guidance & Regulations (IGR PV) Presentation of Safety Risks Throughout the Lifecycle (PoRTL) topic team released its new solution: “A Framework on the Presentation of Safety Risks Throughout the Product Lifecycle.” Developed in accordance with relevant Health Authority guidances, this framework provides an outline of regulatory requirements and considerations for presenting risks within key safety related regulatory documents required at the various product lifecycle stages. For more on this framework and to watch its accompanying video, click here.
The Importance of Harmonizing Clinical Trial Content, Especially in a Post-Pandemic World
We spoke with Missy Heidelberg, senior product development industry collaborations and bioethics leader at Roche and former TransCelerate Clinical Content & Reuse website steward, about recent updates to TransCelerate’s Clinical Content & Reuse Initiative and the importance of harmonizing clinical trial content—especially in a post-pandemic world.
The clinical trial space is at an inflection point. Trial design and implementation are changing and becoming increasingly novel as the research and development landscape continues to shift.
For example, the FDA has encouraged clinical research sponsors to consider using master study protocols for their trials, enabling multiple research sponsors to collaborate while studying the efficacy of their respective therapies. Remote trials are also becoming increasingly common. Now, clinical research activities that have conventionally been done solely at on-site locations are becoming more decentralized, enabled by technology advances and fueled by the remote work environment the COVID-19 pandemic has accelerated.
These changes aim to foster collaboration, streamline harmonized processes and improve the ability to reuse data and content so that the biopharmaceutical community can leverage new and innovative opportunities in clinical trials. As data infrastructure continues to improve, clinical trial data will increasingly be able to flow seamlessly from its point of collection into trial databases both for reuse and to drive additional insights across the clinical research ecosystem.
Content reuse and harmonization of operations is something TransCelerate’s Clinical Content and Reuse (CC&R) Initiative has been supporting since 2014. Since its inception, CC&R has produced an entire suite of templates for clinical trial documents, intended to support the biopharmaceutical community. The templates include a common protocol template (CPT), common statistical analysis plan (SAP), and common clinical study report (CSR) that can be used by all stakeholders in clinical research across all phases of studies.
“The initiative aims to enhance and simplify our most foundational clinical trial processes by providing harmonized structure and proposed model content that can be reused,” notes Missy. “Our goal is to better enable digitization, traceability and sustainability through automation.”
Materials such as the CPT, SAP and CSR allow researchers and authors to extract and reuse relevant data and content for submissions and enable regulators and investigators to access important information within clinical trial documents with greater ease. These harmonized templates also allow sponsors to take an aligned approach to extraordinary events, such as the disruptions caused by COVID-19.
The development of the Clinical Template Suite has been a critical step forward to facilitate consistency among and within clinical study documents, as well as digitization of clinical trial data, but there is still work to be done for the team in both the short-and-long-term.
“We’ve proved it’s possible to harmonize content, but we’re continuing to improve, iterate and align our work with important industry efforts—like ICH, for example,” says Missy. “We want to get the foundation right so that long-term CC&R can accelerate and be one of the foundational components for digital data flow.”
The team released their latest updates to the CC&R Initiative in October. The release included updates that reduced barriers to digital adoption of CPT, SAP, and CSR eTemplates by providing support and guidance on customizing libraries, automating quality registry submissions on ClinicalTrials.gov, and improving functionality to accommodate more complex trial designs.
Separately from the October release, the team also used its well-established foundation in content reuse and medical writing and its deep familiarity with the Clinical Template Suite to support the community in managing the novel difficulties caused by the COVID-19 pandemic. Specifically, a diverse, cross-functional team led by the CC&R Initiative developed Guiding Principles to support researchers as they describe how COVID-19 impacted their studies, to share key points that researchers should consider when they discuss the disruption of COVID-19 to their trials, and to provide sample text that can support researchers and authors to address key considerations in their clinical study reports.
The guiding principles offer a road map for describing how and to what degree a clinical trial was affected by COVID-19 and the level of emphasis it merits in the CSR. For example, a completed study with conclusions should cover the pandemic as an element affecting the trial, but it should not be a focal point. The CC&R team suggests that the most effective summaries highlight only the aspects of the study that were disrupted or changed as a result of COVID-19 and avoid mentioning tactics or findings that were part of the original study plan.
“COVID-19 has required the entire clinical research community to shift and work in new ways. Having processes and templates in place has been helpful in pivoting and moving forward in a unified manner,” says Missy. “The CSR document is a great example. Looking ahead, it’ll be critical to have the structure, trust and process in CC&R in place as we continue to move towards decentralized trials.”
There is a need for a continued push to make content more digital and user-friendly, and the pandemic has only underscored this necessity. Achieving the goals of content reuse and digitization has required extensive effort from the CC&R team and is proving to be worthwhile as the clinical community has needed to find new ways of working since the onset of the pandemic.
Rethinking how basic content is structured and created will enable everyone to extract greater value and help to accelerate clinical research. By taking steps to harmonize and simplify the flow of data and clinical content, clinical research and reporting are more efficient, and the community is well equipped to innovate and, ultimately, bring medicines to patients faster.
As Missy states, “The protocol is at the heart of what we do. By moving towards reusable content and away from documents, we will be able to work in a more flexible and agile way enabling us to find, use and share information more easily—resulting in great benefits to patients and societies as we make medicines smarter and more efficiently.”
For additional information, visit TransCelerate’s Clinical Content and Reuse Initiative Solutions Page.
The Historical Trial Data Sharing Initiative
The COVID-19 pandemic disrupted our collective worlds like never before, but it also fueled collaboration in the biopharmaceutical community on an entirely new scale. The need to develop COVID-19 vaccines and therapeutics with such urgency brought to light the important role data sharing can play in accelerating the development and delivery of innovative new medicines.
One of the many ways TransCelerate Biopharma is working to improve data sharing is through the Historical Trial Data Sharing (HTD) Initiative. It was established to maximize the value of clinical data collected in the control arms of clinical trials by enabling the sharing of patient-level data from completed studies while safeguarding patient privacy.
We interviewed several individuals who have been instrumental in advancing the goals of the HTD Initiative including Jules Desmond, Strategic Development Organization Head, Global Clinical Development at Amgen; Liz Roberts, Data Policy and Privacy Lead at UCB; and Aaron Mann, Global Program Lead, Industry Collaborations Data Sharing Initiatives at Genentech, about data sharing progress, challenges and the future.
Q: Can you explain what the Historical Trial Data Sharing (HTD) Initiative is working to achieve and why it’s important?
A: There is a wealth of value to be gained from historical data in the control arms of clinical trials. Biopharmaceutical companies dedicate significant resources to collecting high-quality, patient-level data, but after a clinical trial is completed, that data can lie trapped inside corporate walls with limited reuse, even internally. Yet, that data holds valuable intelligence that can meaningfully inform challenges that span from discovery and analysis to trial design and execution. As an industry, we also have an obligation to respect patients’ contributions by maximizing the use of data collected during a clinical trial and if possible, by reducing the number of patients needed to participate in the placebo arms of clinical trials.
The HTD Initiative created a module within TransCelerate’s DataCelerate® platform that enables TransCelerate Member Companies to securely share control arm data and support new drug development programs. The data is shared in the industry-standard format and readily interpretable to facilitate sophisticated analysis across multiple studies. With access to this historical information, companies can optimize the way they design future studies, create better experiences for study participants, improve the collective understanding of diseases, and accelerate the execution of clinical trials, bringing medications to patients faster.
Q: Are you seeing companies get more comfortable with data sharing? Did the COVID-19 pandemic change some of the hesitations?
A: Data sharing requires a significant shift in the industry’s mindset. The industry has a history of sharing with other relevant organizations and with academic researchers, but sharing at this scale represents a big step forward. Conceptually, many leaders support the spirit of data sharing among companies to bring new medicines to patients faster but executing any type of behavior change inside organizations is hard. Resources must be committed to changing the way things are done and there must be an awareness of the short-term vs. long-term value of the control arm data that is collected during clinical research. It’s critical to understand that the value of the database grows exponentially over time as more trial data is shared to the database.
COVID-19 gave a new urgency to the HTD Initiative, driving an undisputed need for the industry to share data to solve a global crisis. In response, HTD created a new COVID-19 specific module on the DataCelerate® platform that enables patient-level data sharing of both the investigational product and control arms of clinical trials focused on COVID-19 and other related diseases, along with supporting documentation. As in the HTD Module, the data is pseudonymized or anonymized to protect patient privacy prior to sharing. Access to the COVID-19 module is also available to non-member biopharmaceutical companies and government biomedical research agencies for the first time, provided they are engaged in COVID-19 research and meet a detailed set of participation criteria. This is an exciting development since access to the database has previously been restricted to registered TransCelerate Member Companies. In delivering the new COVID-19 module, we saw companies truly embrace a collaborative spirit of sharing, moving from concept to executed data sharing agreements in a matter of weeks.
Q: Looking beyond COVID-19, how is the HTD Initiative addressing the challenges that surround data sharing? How do you encourage greater adoption?
A: TransCelerate Member Companies are both the creators and consumers of the DataCelerate® database, so the initiative has deep knowledge of the biopharma ecosystem’s intricate regulatory and research standards and requirements. Protecting patient privacy while sharing high-quality, usable data, for example, is always top-of-mind. TransCelerate’s membership requirements include physical, digital, and legal safeguards implemented to protect data sharing, including execution of legal agreements as well as sharing via a secure platform, i.e., the database is not publicly available. Therefore, we’re able to protect historical control data at an appropriate level, while still enabling users to benefit from high levels of data utility.
Fundamental to the success of the initiative is an approach that’s markedly different from other data sharing platforms. Data sharing agreements are executed by and between the participating organizations, setting requirements for contribution quality, privacy protections, and allowed uses. This means that, rather than requiring individual researchers to submit research proposals for each use, the HTD Initiative creates a “walled garden” where any contributed study is immediately available to researchers from all the participating organizations, provided they use it only for the permissible purposes in the data sharing agreement.
We see increased utility and use, intrinsically linked to a willingness to dedicate resources on the contribution side. Still, there is always more work to do. The HTD Initiative has ongoing efforts to further enhance the usability and value of historical control arm data.
Q: What do you envision for the HTD Initiative over the next five years?
A: We want it to become routine behavior for companies to opt to share historical trial data to the database and to use that data to help design, execute and analyze new clinical studies. The more we can encourage and make it easier to upload clinical trial information, supporting data sharing as a business-as-usual activity for all clinical trials, the more powerful the tool will become.
The HTD Initiative is working closely with regulatory bodies, including the U.S. FDA, on using historical trial data in regulatory submissions. With some companies already testing the waters, TransCelerate members are collaborating to help develop guidelines and best practices to help encourage its use by more companies.
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.