Contributed Commentary By Rob DiCicco

August 18, 2017 | Before a clinical trial begins, researchers must be familiarized with and aligned on study objectives and endpoints, and be able to articulate clear instructions on how the trial itself will be carried out. The most important component of this process is the clinical trial protocol—the document that details the specific plan to guide the clinical trial. Ideally, investigators and clinical study teams would be able to focus on critical elements of design and execution of the trial. Historically the process of protocol development has been highly manual and customized, and this element of complexity puts a burden on reviewers (ethics committees and regulators) and investigational site staff. Considerable time is spent trying to locate information and interpret the different ways critical protocol elements are described or defined. This sometimes lead to delays, errors, and sometimes both.

The number of new clinical studies registered in Clinical Trials.gov have soared since 2010, increasing by 20,000 each year. That means 20,000 new studies sponsored by academic institutions, biopharmaceutical companies, contract research organizations (CROs), and National Institute of Health (NIH) researchers, to name a few. The volume of clinical research activity compounds the problem statement above.

In the absence of commitment to harmonization—having content in the same place across protocols—R&D organizations will continue to struggle with protocols that will become increasingly complex and difficult to navigate. Since many industry sponsors, clinical research organizations, and academic institutions develop their own template, an approach to protocol authoring, there may be unnecessary time spent providing clarifications and creating major amendments. In addition to delays, this also creates a quality risk as a function of protocol deviations. However, clinical trial sponsors, investigators, and regulators are aligned on the collective goal to collaborate on a model clinical trial protocol template with a common structure that all stakeholder groups can interpret in the same way. Such a template must be streamlined and consistent, enable model language for important protocol content for all study phases and include endpoints and study procedures that map directly to study objectives.

Fortunately, we’re making progress in harmonized protocol development as organizations such as TransCelerate are addressing this pressing need in clinical research by identifying key principles needed to create a protocol template through its Common Protocol Template (CPT) Initiative. The idea behind this effort is grounded in the organization’s mission: when the industry streamlines and harmonizes processes, burden is reduced and the road to innovation is paved. In short, the CPT is a means to facilitate creativity in clinical research.

A common protocol template is just the beginning. This entire process is being modernized—it’s going digital, becoming cloud-based computable and reusable from site to site. Not only is the industry moving toward a digitally-enabled protocol, but patient-centricity is also driving how protocols are being developed. For example, biopharma companies are leveraging technology to run contests to obtain feedback from patients on trial design, informed consent forms (ICFs) and the trial protocol itself—one great example includes TransCelerate Member Company Eli Lilly’s Clinical Trial Visualization Redesign Challenge. To ensure participant needs are ultimately met, patient and public involvement in protocol development is greatly needed to truly help shape clinical trial protocols for the better.

With the support of its Member Companies, TransCelerate extensively reviewed practices and protocols across its membership and solicited inputs from health authorities, sites, and ethics committees to issue a model way to articulate clinical protocols. Further harmonization was achieved recently, by aligning efforts with the NIH and the Food and Drug Administration (FDA), particularly, aligning and modernizing protocol templates in this manner will help maintain the overall quality of protocols, enable efficient review processes and elevate patient safety.

TransCelerate has worked diligently over the past few years to address pain points in protocol-related issues that have been voiced by investigator sites, regulators, trial sponsors, and patients. Should industry-wide adoption of a technology-enabled CPT occur, the benefits would be seen across numerous stakeholder groups:

• A level of increased consistency between sponsor protocols from site to site
• Reduction in human error further eliminating errors that slow trials and increase complexity for regulators
• A decreased need for burdensome workflow documentation that overwhelm sites
• Improved access to streamlined and organized clinical trial protocols between various sites
• Decreased complexity in the review process to streamline efforts for regulators
• Increased ease in data interpretation for regulators
• Improved communication across sites and between patients
• Greater patient access to protocol information
• Greater efficiency in the overall drug development process, benefiting all stakeholders

In addition to the benefits stated above, the consistency achieved through this effort is foundational for introducing digital solutions to drive higher quality and improving efficiency for all stakeholders.   Enabled by emerging technology it is anticipated that leveraging this type of harmonization and connecting it to critical downstream processes related to study planning, clinical trial execution and reporting will accelerate the delivery of important medicines to patients.

Rob DiCicco, PharmD, is part of Clinical Innovation and Digital Platforms at GSK and is the TransCelerate Common Protocol Template (CPT) Initiative Leader. He can be reached at Rob.DiCicco@transceleratebiopharmainc.com.