As the head of PRA’s Global Center of Excellence for Decentralized Clinical Trial (DCT) Strategy, Dr. Isaac Rodriguez-Chavez is in charge of overseeing growth and development, regulatory framework, and modernization of virtual trial strategy for the contract research organization. His work is informed by more than 32 years of experience in the field, most recently as senior officer for clinical research methodologies, regulatory compliance and medical policy development with the US Food and Drug Adminisration (FDA) Center for Drug Evaluation and Research.
Outsourcing-Pharma (OSP) recently spoke with Rodriguez-Chavez (IRC), also senior vice president of scientific and clinical affairs for PRA Health Sciences, about the fascinating developments in the DCT field, and why trial professionals should brace themselves for even more evolution in the coming year.
OSP: Can you share some of the reasons why you’ve decided to bring your expertise and experience to PRA and the Global Center of Excellence for DCT Strategy?
IRC: I decided to join PRA to lead the Global Center of Excellence for DCT Strategy and help enable their implementation with novel digital health technologies because PRA is a leader in the industry when it comes to its infrastructure, people, and experience in providing excellence in a global suite of clinical research and healthcare services. PRA takes the right approach when it comes to assisting individuals with their healthcare needs using a human-centric approach and the latest innovations in healthcare systems.
I am honored to help lead the Center, especially in this time of exponential adoption of modern clinical trial designs in the industry.
OSP: What are the Center’s goals for 2021, and years to come?
IRC: The Global Center of Excellence for DCT Strategy will continue PRA’s mission of making healthcare more accessible by minimizing the burden on patients to participate in clinical research. The Center will be the driving force of innovation in providing direct care to patients.
The goal of the Center is to continue to grow and develop PRA’s industry-leading decentralized clinical trial strategy, regulatory framework creation, and clinical trial modernization. The sooner we shift clinical research away from traditional models and integrate it into patients’ everyday lives, the sooner we can democratize and diversify research.
OSP: How has the DCT arena evolved in recent years? What trends did professionals see emerge and grow in the past year?
IRC: For decades, clinical trials have been designed and conducted in the same manner, even despite advances being made in biology and genetics, combined with groundbreaking technology innovations, the industry has been unsuccessful in evolving and modernizing our approach to drug development. This is especially the case when it comes to ethnic minority groups.
The drug development research paradigm is flawed in that it fails to include a diverse and representative patient population. This is something that PRA and the clinical research industry as a whole is trying to improve upon. You can learn more about how decentralized clinical trials are bridging the diversity gap in clinical research here: https://bit.ly/3apbLM6
OSP: How has the industry’s use of and attitudes toward DCTs shifted in the past year?
IRC: We have seen a shift in the industry towards decentralized clinical trials, especially since the onset of the COVID-19 pandemic. Many sites were inaccessible due to global shutdowns put into place because of COVID-19; along with shutdowns and stay-at-home orders, patients weren’t as likely to go to their routine in-office doctor visits and non-COVID-19 related appointments due to the fear of contracting COVID-19.
The industry has had to turn to telehealth and remote patient monitoring now more than ever before, and we can only expect this to continue even after COVID-19.
OSP: How has COVID-19 impacted DCT use and strategy?
IRC: The COVID-19 pandemic has tremendously impacted how clinical trials – and healthcare as a whole – are being conducted. Healthcare in general, but especially clinical drug development, simply cannot afford to remain stagnant in how we engage with patients. Since the onset of COVID-19, we have had to evolve and adapt to this new environment, bringing the idea of decentralized clinical trials to the forefront of drug development and the entire healthcare landscape; it is vital that we ensure our practices are realistic and maintainable for the patient population.
OSP: Obviously the pandemic loomed large, but what other factors have impacted DCTs in 2020?
IRC: Yes, COVID-19 has been the catalyzer for exponential adoption of decentralized clinical trials using DHTs in the field. However, other factors that have impacted DCTs this year include the development of a regulatory framework in the form of guidance materials that support DCTs and the use of DHTs, published by regulatory agencies such as the US FDA, quick technological improvements with enhanced adoption in DCTs, and an increased demand for telehealth services in the standard healthcare system that served as a model to modernize clinical trials.
Some changes in telehealth policy that represent advantates include the expansion of services to patients in healthcare systems permanently and cost-savings and revenue growth for hospitals, improving efficiencies.
OSP: Then, if you could gaze into your crystal ball, how might the DCT world shift in the coming year?
IRC: Even before the COVID-19 pandemic, the industry was experiencing a gradual shift towards more remote clinical studies and procedures, but not at the rates we have seen DCTs being adopted since the onset of COVID-19.
We now see DCTs as an irreversible trend that will continue to be offered as a healthcare option across the industry; however, this is something that is unlikely to happen overnight. It will be up to pharmaceutical companies to incorporate digital health approaches to support aspects of studies.
OSP: What advice would you give pharma firms and their research partners on how to best brace themselves for a successful 2021?
IRC: We must embrace the change to healthcare with a progressive approach in order to develop and implement DCT-specific solutions in clinical trials. This change is here to stay – it is irreversible. We must be more patient-centric in our approaches to healthcare and be open to incorporating digital health practices into research.