Assumption on my side is that if you are reading this article, then you probably are familiar with the TransCelerate organization and TransCelerate Common Protocol Template (CPT) initiative.
If not, I would just briefly mention that TransCelerate is a not-for-profit organization focused on collaboration across the pharmaceutical industry with a task to overcome inefficiencies in the processes and solutions.
The CPT is a streamlined model for clinical trial protocols that includes an agreed format (template) and core content (standardized in libraries or defined variables within the protocol). As such, the CPT presents the information that is always in the same place and with the same meaning for all stakeholders. This is a very important principle as it ensures that clinical trial protocols are written based on standards and can be represented by a set of pre-defined protocol data elements which can be shared in electronic form with the downstream processes.
The CPT benefits are typically time-boxed into near-term and potential future benefits. Without going through a detailed list of those benefits for all stakeholders (sponsor, sites, IRB, Patient and regulators), I will focus on the ones applicable to the sponsors.
Sponsor near-term benefits:
- Reduction in protocol content redundancy
- Utilization of clinical standards (Therapeutic Area)
- Improved study setup, conduct and data quality
Sponsor potential future benefits:
- Automation of downstream processes and reuse of content
- Introduction of additional clinical standards (additional Therapeutic Areas)
- Enabling collaborative clinical trials
Even if one is just considering the near-term benefits, they represent a major step ahead for many sponsor organizations and a great value add by CPT implementation. Though many sponsors have a clinical trial protocol template that they use across their clinical projects, very few are able to ensure the necessary consistency and standardization of the information across protocols. The future benefits, if realized, would represent a giant leap compared to the today’s state for many of the sponsors.
Considering the potential benefits and rewards of utilizing the TransCelerate CPT, the sponsors would need to take into a consideration the following questions:
- How do we transition from the current state of our clinical trial (study) planning to the CPT enabled future state?
- How do we ensure that potential future benefits become the realized future benefits?
- How do we raise above the clinical trial planning and plan clinical projects with the same benefits of clarity, consistency and standardization across all trials?
Question 1: How do we transition from the current state of our clinical trial (study) planning to the CPT enabled future state?
This question is by far the easiest to address and one would probably start with the mapping tool provided by TransCelerate organization. Using this tool, the sponsor organization would map and compare an existing protocol template to the TransCelerate Common Protocol Template. Once the comparison analysis is completed, the sponsor would be clear on how to transition from the existing template to a CPT template of to an ‘adapted CPT template’ with the sponsor changes to it (sponsor flavored CPT).
Having done that transition, the sponsor would join all other adopters of the CPT and would be able to present its clinical trial protocols in the same and familiar form to investigators and also benefit from available clinical standards.
Question 2: How do we ensure that potential future benefits become the realized future benefits?
This question is slightly trickier as it depends on sponsors readiness to utilize the CPT in a technology enabled edition and on TransCelerate organization to provide technology updates and clinical standard libraries relevant for particular sponsor’s therapeutic areas.
The sponsors would need to address the topics of management and governance of the clinical standards libraries and the technology updates to match those processes.
Alternative approach is to eliminate the coupling and dependency on the technology provider over which one has no or very little control but still benefit from the CPT as a familiar and industry recognized template. This approach is based on a Structured Study Development (SSD) concept integrated with the Common Protocol Template.
The key principle behind this concept is that the Clinical Trial Planning is performed in a structured format and the protocol document is just another view of that structured format. In other words, all protocol data elements are provided and managed and maintained in a structured form, which can at any point in time be presented in a Common Protocol Template for reviews and distributions. The structured data (which is exactly the data that is available in the protocol as well) can be provided to all downstream systems for study setup, conduct and reporting.
Intilaris specializes in enabling Pharma Sponsors to introduce Structured Study Definition concept integrated with CPT for ensuring clarity, consistency, downstream automation and standardization of the clinical trial protocols.
Question 3: How do we raise above the clinical trial planning and plan clinical projects with the same benefits of clarity, consistency and standardization across all trials?
Reaching the same level of clarity, consistency and standardization would require departure from a trial centric approach and look at clarify and consistency of definitions as well as standardization across all trials within a clinical project. Even though it would be possible to address this question with a Technology Enabled Edition of CPT, it would present itself as an enormous organizational and collaboration challenge. So far, I am not aware of sponsors embarking upon this path and overcoming these challenges.
A simpler approach would be to execute the SSD integrated with the CPT on a clinical project level. In this approach, a clinical trial would be a one of the trials planned and designed for the clinical project in the same structured form governed by the SSD. Such project SSD would be able to provide:
- Transparency of the standards and their utilization across all trials
- Assurances that clinical trials supporting the same clinical claims within the project are comparable and can be pooled for analysis
- Overview of any discrepancies between trials
- Clear responsibilities across all trials
- Collaborative environment for planning clinical trials that are aligned and supporting agreed clinical claims
- Platform for clinical data elements exchange between: Any downstream systems in electronic form AND Any downstream process in a visual form (e.g. diagram or document)
Our TransCelerate Common Protocol Template experience
Intilaris has been working on SSD approaches with major Pharma Clients where we provide the configured low technology tools (through MS Office package) and a know-how to help our clients to adopt the structured and standardized way of clinical project and study planning.
For an obligation free and a detailed discussion on a client-specific approach on adoption of the Common Protocol Template and introduction of the Structured Study Definition process in your Clinical development organization, reach out to intilaris at firstname.lastname@example.org
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