We Need Your Input
Master Protocol Design & Implementation Survey
Master Protocols provide the design of clinical trials intended to simultaneously evaluate more than one intervention and/or more than one disease type within the same overall trial structure in adult and pediatric disease/conditions (FDA Guidance March 2022: Master Protocols: Efficient Clinical Trial Design Strategies to Expedite Development of Oncology Drugs and Biologics).
The TransCelerate Clinical Content & Reuse (CC&R) team launched the first edition of the Common Protocol Template (CPT) in 2016 for use in all phases of interventional clinical trials (though not expressly designed with master protocols in mind). The CC&R team would like to understand what makes a successful master protocol, including insight into challenges related to master protocol design and, for CPT users, if and how the CPT may be used to capture the more complex aspects of master protocols . To that end, we are requesting your input on a brief survey regarding Master Protocols (MPs). Please follow the link below.
As always, participation in TransCelerate surveys is voluntary. Responses will have all identifying information removed by the PMO/TransCelerate legal before sharing with the team.
Master Protocol Design & Implementation Survey
What’s New
The TransCelerate Clinical Content & Reuse team congratulates the members of the IMI-sponsored EU-PEARL team on the launch of the Master Protocol, Intervention Specific Appendix (ISA or subprotocol), and Statistical Analysis Plan included in the generic template suite for integrated research platform trials. This three-year initiative culminated in the release of master protocol, ISA, and statistical analysis plan templates based on TransCelerate’s Clinical Template Suite (CPT & SAP templates) as well as other supporting assets. You can find these tools by following this link to EU-PEARL’s Suite of Master Protocol Templates.
What is Clinical Content & Reuse (CC&R)
Click on the Harmonized Model Content, Reuse Capabilities and Clinical Template Suite sections to learn more about CC&R.
The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by providing harmonized structure and proposed model content within clinical trial documents that can be reused throughout the project lifecycle to enable digitization and traceability through automation.
Reuse Capabilities
What’s New
In 2021, the CC&R Team conducted a proof of concept exercise & landscape analysis to determine the general feasibility of establishing a procedures library to support protocol design and digitization. The results of that exercise, aimed at supporting the evolution towards a digitized protocol have been summarized in a white paper, Examining Possibilities for a Consistent Procedures Library to Modernize Clinical Trials: A TransCelerate Point of View.
Content reuse capabilities aim to enable digitization, traceability, and the opportunity to reuse content for downstream processes, documents, and registries through use of the Clinical Template Suite (CTS). The CTS works towards having electronic, machine-readable documents and improving overall end-to-end efficiencies by enabling content reuse through automated export and import of shared information into the appropriate sections of the Common Protocol Template (CPT), common Statistical Analysis Plan (SAP), and the common Clinical Study Report (CSR).
Content reuse provides the opportunity to optimize and connect clinical trial processes, transform the study design process, and connect metadata to other systems by writing content once and reusing as needed. Content reuse promotes interoperability and traceability while providing the foundation for digital data flow.
Harmonized Model Content
Guiding Principles for Clinical Content & Reuse
Structure must:
- Be streamlined
- Be consistent
Content must:
- Develop common wording for use across multiple documents or processes
- Align with GCP, ICH, & EU requirements
The Clinical Content & Reuse team actively engages with industry stakeholders, investigators, study coordinators, members of Institutional Review Boards (IRBs), Institutional Ethics Committees (IECs), the TransCelerate CRO Forum, and regulatory authorities for input and feedback into the Clinical Template Suite (CTS). Since May 2017, the CPT has aligned its structure with the common protocol template launched by the U.S. Food and Drug Administration (FDA) and National Institutes of Health (NIH) to improve ease of review.
The templates include a common structure, proposed text, and libraries of regulator-accepted endpoint definitions that align with Clinical Data Interchange Standards Consortium (CDISC) Therapeutic Area (TA) data standards. The harmonized structure and model content aim to reduce complexity and maintain consistency while easing review and interpretation by IRBs, IECs, and Health Authorities across the lifecycle of a clinical trial.
Clinical Template Suite
The Clinical Content & Reuse (CC&R) Initiative aims to enhance clinical trial processes by developing common content for reuse across clinical trial documents in the Clinical Template Suite (CTS). The CTS works towards having electronic, machine-readable documents and improving overall end-to-end efficiencies. The CTS includes basic Word and technology-enabled eTemplates for the protocol (CPT), statistical analysis plan (SAP), and clinical study report (CSR). The adoption of the templates is at the discretion of the user. Tools, guidance, and FAQs for templates and eTemplates, are available on the Clinical Content & Reuse Assets page.
The eTemplates, eCPT, eSAP, and eCSR are Word documents with technical functions enabling automation and clinical content reuse to downstream documents, processes, and registries. The eTemplates can be used independently or together.
The CPT is a harmonized and streamlined approach to the format and content of clinical trial protocols. The CPT includes a common structure, proposed model text, and regulator-accepted endpoint definitions for use across protocols with little to no editing at the discretion of the user.
The Common SAP provides a common layout and model content for SAP documentation, which seamlessly integrates with the CPT and CSR. The template aligns with ICH E9 (R1) for the use of estimands. In addition, the template addresses global regulatory requirements for reporting and disclosure.
The Common Clinical Study Report (CSR) aims to provide a lean, common, and streamlined structure to report data (no benefit/risk interpretation). The CSR has common wording consistent with CPT, adheres to global requirements, enables disclosures, and avoids redundancy by referring to appended documents.
Bringing Value to Our Stakeholders
Value to regulators:
- Increases use of data standards with streamlined structure and content
- Improves access to protocol information
- Reduces complexity while easing the review and interpretation by IRBs, Ethics Committees, and Health Authorities across the lifecycle of a clinical trial
Increased use of CPT across Sponsors brings value to sites by:
- Streamlining the structure and content thus improving access to protocol information and increasing consistency across sponsors
- Providing easy access to the schedule of assessments, establishing clear alignment between objectives and endpoints
- Enabling references to documents that facilitate study conduct (e.g., study manuals, pharmacy guides, etc.) to avoid duplicative and lengthy protocol sections
Increased use of common clinical content in the protocol can also have a positive impact on patients by:
- Improving access to protocol information
- Facilitating efficiencies across protocol development and implementation processes so that clinical and medical staff can focus on the patient
Benefits for Sponsors:
- The CPT was designed with data standards and libraries and includes regulatory and site feedback aimed at easing submission to health authorities and ethics committees
- The Clinical Template Suite includes the SAP and CSR templates, which are aligned to the CPT and ready for use and implementation
- The eTemplates enable digitization and reuse of content for downstream processes, documents, and registries
Benefits
The Clinical Content & Reuse Initiative aims to enhance the clinical development process across clinical trial sites, regulators, patients, and sponsors.
Implementation Experience
As solutions are used throughout the R&D ecosystem, TransCelerate receives feedback related to solution implementation experiences. Anyone can submit an experience through the Engage with Us page and in select cases, we share the experiences on Our Impact page in a blinded way. Below is a featured example for this initiative:
Available Solutions
Please see the Initiative Solutions page for guidance and to download our Clinical Template Suite.
Disclaimer
These materials are provided ‘AS IS’ WITHOUT WARRANTY OF ANY KIND, EITHER EXPRESSED OR IMPLIED, INCLUDING, BUT NOT LIMITED TO, THE IMPLIED WARRANTIES OF MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR NON-INFRINGEMENT. TransCelerate and its members do not accept any responsibility for any loss of any kind including loss of revenue, business, anticipated savings or profits, loss of goodwill or data, or for any indirect consequential loss whatsoever to any person using these materials or acting or refraining from action as a result of the information contained in these materials. Any party using these materials bears sole and complete responsibility for ensuring that the materials, whether modified or not, are suitable for the particular use and are accurate, current, commercially reasonable under the circumstances and comply with all applicable laws and regulations.
Nothing in these documents should be construed to represent or warrant that persons using these documents have complied with all applicable laws and regulations. All individuals and organizations using these documents bear responsibility for complying with the applicable laws and regulations for the relevant jurisdiction.
