October 2022: Innovating in Clinical Trials

October 2022: Innovating in Clinical Trials

Vertex Dr. Carmen BozicWe are pleased to present the second in a three-part series on clinical trials sponsored by Vertex Pharmaceuticals Incorporated. This article was written by Carmen Bozic, M.D., Executive Vice President, Global Medicines Development and Medical Affairs, and Chief Medical Officer, Vertex Pharmaceuticals.

Click to read the first article, What Are Clinical Trials and Why Are They Important?

Patients are at the center of everything that we do at Vertex. It’s this value that drives us to continuously invest in scientific innovation with the aim of creating transformative medicines for people with serious diseases. To accomplish this, we’re innovating across our organization, in every aspect of our business – including our clinical trials. We are proud to recognize the incredible patients, caregivers, physicians, and site staff who participate in and support our clinical trials, as well as the many Vertexians working relentlessly to get potential medicines to patients as quickly and safely as possible. Specifically, I am going to share a bit more about our experience with decentralized clinical trials and how it helps us promote diversity in our trials.

Our journey to decentralized clinical trials:

In January 2020, our Global Clinical Operations (GCO) team was preparing a proposal to pilot Vertex’s first fully decentralized clinical trial (DCT). A clinical trial is considered decentralized when some, or all, of it may be conducted from the comfort of the patient’s home. Assessments can be made through telemedicine, mobile/local healthcare providers, and wearables such as activity watches and heart monitors. At the time, DCTs were considered an optional, even experimental, way to complement traditional study methods. Then COVID-19 made us rethink how we approach clinical trials. We could have scaled back or paused ongoing studies, but instead, we used this as a launching pad to continue the momentum of this pilot program and rise to the challenge of continuing our clinical trials during a pandemic.

Decentralized clinical trials allow us to meet patients where they’re at. They teach us how to better connect with patient communities, and to educate them on the benefits of clinical trials.

Enhancing diversity in clinical trials:

Across our pipeline, we work on diseases that affect people who identify across a multitude of demographics. Site selection is driven by the need to be accessible and inclusive so we can recruit a population reflective of the patients impacted by these diseases globally. By bringing together the digital experience for patients and trial sites, we make the trial less burdensome, and we can create a seamless approach to support trial participation from anywhere - and this gives us the opportunity to extend access to new patients regardless of location or proximity to major medical centers through technology.

Jacqueline, 'Jacquie', Curtiss, Vice President, Global Clinical Operations, who authored the first article in this series, explains that "Global Clinical Operations is comprised of Vertexians across the globe, all of whom are incredibly committed to ethical and high-integrity clinical trials. It is crucial that these trials are always performed with the patient's safety in mind. For us, it is more than a job. It's a passion we have for the patients that we serve every day."

The commitment of Vertexians like Jacquie, and countless others, plays a critical role in our mission to develop transformative medicines that address the unmet needs of patients living with serious diseases. As I reflect on the progress being made in our decentralized clinical trials, I am immensely proud of our commitment at Vertex to leverage cutting-edge technologies, clinical expertise, and our patient-centric focus to continue pushing the boundaries of what is possible in this exciting space.

© 2022 Vertex Pharmaceuticals Incorporated | VXR-US-02-2200226 (v1.0) l 08/2022