How Clinical Protocols Are Developed Today
Within the field of Clinical Development, clinical scientists are responsible for designing clinical trial protocols aimed at showcasing an intervention’s efficacy and safety, as well as generating evidence necessary to both position the product for regulatory approval and successful commercialization.
To design protocols, clinical scientists typically follow a series of steps. While the exact approach and terminology may vary from organization to organization, the process usually looks something like this:
- Develop a TPP – Like the name implies, a Target Product Profile is used to set a target, for what the product in development would ideally demonstrate in terms of efficacy and safety to be impactful for patients, and to be adopted in clinical practice. It may also capture other key characteristics of the product, such as route and frequency of administration, that would be optimal. This is used to understand what value the product would have to deliver to be successful from both a regulatory and commercial perspective.
- Draft a Concept Sheet – This is a high-level summary of the scientific background, any preliminary data or hypotheses, and proposed objectives and endpoints for the study. The concept sheet is used to facilitate internal alignment on whether the study should move forward in development.
- Write the Synopsis – After gaining approval to continue based on the concept sheet, clinical scientists will write a synopsis, which is a more detailed summary of the proposed clinical trial, usually 2-3 pages long, containing descriptions of all of the main elements of the final protocol.
- Develop the Full Protocol – After gaining further alignment and approval with the help of the study synopsis, clinical scientists collaborate with their colleagues to build the full protocol, including the detailed Schedule of Activities, outlining every assessment to be conducted and measurement to be taken on each visit day during the clinical trial. The protocol document is ultimately submitted to the regulatory authorities for review and approval prior to initiating the trial.
Clinical scientists are experts at what they do, and may routinely work on multiple protocols at a time, handling a huge volume of information and coordinating numerous stakeholders in the months’-long process of developing a final protocol. But the way the work gets done today creates some real challenges both for clinical scientists themselves, and for the rest of the organization.
What is the “Traditional” Way of Working, and Why is it a Problem?
Let’s explore the issues in both the current process by which protocols are developed and the tools that are used:
Process
As the protocol is developed, decisions are frequently guided by the sponsor’s interpretation of regulatory requirements, past program experiences, and expert clinical and scientific judgment. While leveraging these resources and experience can help mitigate some risks, designing trials based solely on prior experience and subjective judgment means that teams often miss out on opportunities to optimize the protocol based on objective, quantitative data, metrics, and analytics. Without being able to easily quantify the impact of individual decisions, teams can inadvertently design protocols that aren’t optimized for patient burden, operational risk, and cost. It can also lead to downstream amendments, at least some of which could have been avoided if brought to light earlier in the process.
Tools
At the same time, it’s no wonder that the process looks like this when the predominant tool used for developing protocols is still Microsoft Word. While Word is unquestionably valuable and necessary for documenting and sharing the final protocol, it’s not optimized for activities that require iteration, data-driven decision-making, or structured data. As a result, clinical scientists, medical writers, clinical data managers, and other stakeholders involved in the process all experience the frustration of tedious busy-work, like document cleanup, and have to frequently conduct their work in sequence rather than in parallel, creating significant inefficiency.
How a Study Designer Can Help
A study designer is a dedicated tool that has been purposefully designed for clinical scientists and the teams that are part of protocol development, to address the challenges outlined above. While the benefits of a study designer are many, some of the most impactful benefits of Faro Health’s Study Designer are summarized below:
Optimizing Protocol Design
By structuring the protocol in a digital format, Faro’s Study Designer enables clinical development teams to quantify trial complexity, make data-informed decisions, and mitigate the risks associated with inherently complex trials. Whether “optimization” takes the form of reducing patient burden, managing costs, or another goal for any given sponsor, the Study Designer enables teams to deeply understand the impact of their decisions, make changes where warranted, and explain or justify their choices to internal and external stakeholders.
Maximizing Team Resources
Clinical scientists, and clinical development teams in general, are often stretched thin and under time pressure. The collaboration features and GenAI authoring tools of Faro’s Study Designer maximize existing team resources, so they can get more of their best work done, in less time.
Improving and Maintaining Quality
As noted in the preceding section, using Word to design clinical protocols can lead to a whole host of tedious busy work and quality-checking on the part of the clinical team. With Faro’s Study Designer, reusable components like dynamic fields and pre-written text snippets enforce consistency and best practices, eliminating the need to do the dreaded “find-replace” exercise every time a global change is needed. What’s more, Faro’s approach to iterative GenAI models produces high-quality, complete content, in a consistent style and tone across multiple editors.
Avoiding Amendments
Last but not least, another benefit of using Faro’s Study Designer is the potential to reduce avoidable protocol amendments. Leveraging Faro’s real-world insights during protocol design and optimization inherently gives teams the ability to identify and flag issues or potential changes early in protocol development, saving significant time and cost for every amendment that can be avoided
Summary
Developing optimized clinical protocols is a critical, essential step in the overall process of clinical development. Clinical scientists devote countless hours, research, and subject matter knowledge to thoughtfully developing protocols that will serve the needs of the program, sponsor organization, site stakeholders, regulators, and ultimately, patients. Today, this essential step in development is unnecessarily held back by the traditional process and tools used that have been used for decades, leaving a significant opportunity for improvement. Faro Health has built our Study Designer to directly address these issues, enabling teams to deliver more of their best work, in less time, simultaneously optimizing for the metrics that matter most.
To learn more about how Faro’s Study Designer could help your organization, please contact us here.