Guest Column

Collaboration created the cornerstone of better clinical trials – now, it’s time to build

By Pamela Tenaerts, executive director, Clinical Trials Transformation Initiative (CTTI)

- Last updated on GMT

(Image: Getty/Sarinyapinngam)
(Image: Getty/Sarinyapinngam)

Related tags: Clinical trial, Collaboration, Real world evidence, Real world data, Patient centricity, Patient

We entered 2018 with a solid foundation in place for building better, more efficient clinical trials. Throughout the year, progress – particularly in the areas of mobile technologies, real-world evidence, and patient engagement – resulted in new, tangible building blocks for constructing the future of clinical trials.

For many years, experts and leaders across the clinical trials enterprise—regulators, industry, patients, clinicians, researchers, and many others—have come together to address seemingly insurmountable obstacles to efficient clinical trials.

The Clinical Trials Transformation Initiative (CTTI), a private-public partnership co-founded by the US Food and Drug Administration (FDA) and Duke University, has played an instrumental role in leading such efforts. By blending diverse viewpoints, challenging the status quo, and working together over the past decade, we create evidence-based solutions to clinical trials obstacles and pathways to new opportunities.

Making Mobile Clinical Trials a Reality

The clinical research community has long discussed an exciting future of using mobile technologies to collect objective, reliable data in clinical trials. CTTI is paving the way for the research industry to successfully navigate the shift toward using mobile technologies.

In 2018, we released recommendations and resources for using mobile technologies in clinical trials​—from selecting a technology at the beginning of a trial to preparing for FDA submission using data generated from the technology. Our multi-stakeholder work also resulted in new approaches for overcoming hurdles​ associated with decentralized clinical trials​.

Moving into 2019, additional efforts from CTTI and other groups will continue this momentum and make mobile clinical trials a more common reality.

Moving Real World Evidence Forward

Another area of opportunity is the use of Real World Evidence​ (RWE). More than just buzzwords, RWE is the idea that data from our everyday lives can help answer questions that would otherwise be impossible to answer. Despite growing interest, effective approaches for leveraging real-world data sources to enhance clinical trials are lacking.

CTTI has convened experts on this topic and next year will release actionable solutions​ for sponsors, investigators, and contract research organizations. CTTI is not alone—watch as more stakeholders come together to help apply RWE to answer important clinical questions.

Engaging Patients Early and Often

Engaging patients at every step of the research process is crucial to a successful trial. Requirements of the Prescription Drug User Fee Amendment (PDUFA VI) call for more patient involvement in the research process.

In 2018, CTTI and the FDA held the inaugural meeting of the Patient Engagement Collaborative​. This new group works closely with the FDA to discuss topics such as communication, transparency, and the best ways for patients to participate in the FDA’s regulatory discussions about medical products.

In the year ahead, CTTI will release new resources to support greater inclusion of patients during planning and execution of regulated and other trials across the clinical research enterprise.

The road ahead is an exciting one. Mobile technologies, RWE, and patient engagement will continue to evolve and other key areas—including trial quality and novel trial designs—will make great progress.

We enter 2019 with a solid foundation and—more so than ever before—the building blocks needed to construct better, more efficient clinical trials. Let’s start building. 

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