How medical research is conducted has changed over the years, with patient-centricity in clinical trials representing a critical shift in the landscape. Positioning patients' needs, values, and experiences has become a priority, ensuring that therapies are innovative, practical, and impactful for those who rely on them. Amy Cripps, MD, a medical oncologist and Medical Director at Parexel, has made it the heart of her mission. She champions patient-centric approaches, believing they're essential to advance care for oncology patients and their caregivers.
The shift toward patient-centricity—a response to the lingering challenges within the industry—has been long overdue. Clinical trials have consistently evolved throughout the years. For instance, the emergence of randomized controlled trials (RCTs), statistical methods, and ethical guidelines like the Nuremberg Code and the Declaration of Helsinki improved scientific rigor and patient safety. These developments ensured that trials were conducted ethically and that the data collected was reliable.
The field further matured. Molecular biology and genetics brought a new dimension to clinical trials in the late 20th century, and researchers began straying away from one-size-fits-all approaches and studying how individual genetic and molecular profiles influence treatment outcomes. This move paved the way for precision medicine, where therapies are tailored to a patient's unique biological characteristics.
Oncology, which leverages advancements in genomics and molecular diagnostics to develop therapies that target specific genetic mutations, cellular pathways, and tumor microenvironments, has been at the center of precision medicine. It's worth noting that clinical trials, especially in this field, have shown increased success rates thanks to the integration of biomarkers and companion diagnostics.
Dr. Cripps acknowledges that the progress is immense, but accompanying it are new complexities. She states that precision medicine requires better collaboration among stakeholders (from pharmaceutical companies to regulators) and input from patients so that trial designs align with their needs and preferences. Dr. Cripps, therefore, made it her goal to champion patient-centric trials that prioritize transparent communication, simplify participation processes, and design endpoints that reflect outcomes meaningful to patients.
The seasoned medical oncologist combines her extensive experience and dedication to improving patient care to make an impact. As the owner of Oncology Consulting, LLC, she expands access to essential programs for oncology practices and clinicians. Her consulting projects are grounded in patient-centric principles, addressing the challenges oncology practices face in delivering value-based care, precision medicine, and supportive programs for patients.
This work aligns with Dr. Cripps' role as Medical Director at Parexel, one of the largest global clinical research organizations (CROs). Parexel has received the prestigious Society for Clinical Research Sites (SCRS) Eagle Award for two consecutive years. This accolade recognizes organizations advancing clinical research through exceptional site partnerships. Moreover, the company was named "Top CRO to Work With" by investigative sites worldwide in the 2023 WCG CenterWatch Global Site Relationship Benchmark Survey, reflecting its reputation for building trust, collaboration, and innovation in clinical research.
Dr. Cripps joined the globally renowned organization because of its "With Heart™" philosophy, which captures Parexel's commitment to excellence and employing a patient-first approach. "We recognize that patients are not just participants in trials. They're our partners. Their experiences and perspectives inform our research's design and execution," she remarks. These words ring true, given that the company assists in the design of clinical trials that give patients a voice, treat them with dignity, and prioritize their needs.
The experienced medical oncologist stresses that oncology patients, who usually face emotional, physical, and financial burdens, deserve trials that are as accessible and non-invasive as possible. She has witnessed firsthand the evolution of the clinical trial landscape. For instance, more organizations are enhancing their efforts in patient engagement and support. They're introducing personalized patient support programs (e.g., telehealth services, home healthcare visits, etc.), partnering with patient advocacy groups, and establishing patient advisory boards.
"Many clinical trial patients travel long distances, and so rather than making them travel back and forth for visits, telehealth enables them to stay where they are, allowing experts to serve them in their home or local community," she shares. Dr. Cripps has also seen the simplification of the informed consent process, guaranteeing that patients and their families fully understand the implications and benefits of their participation. In addition, regulatory bodies have concentrated their efforts on expediting the approval of drugs, making the clinical trial process more comprehensive for stakeholders. These are only a few of the many changes in the landscape.
Dr. Amy Cripps looks forward to seeing technological advancements further enhance patient-centric clinical trials. She highlights the growing role of telehealth, social media, and other outlets in increasing patient access and awareness. Moreover, the medical oncologist is optimistic about the potential for innovative trial designs, including decentralized clinical trials, where trials are brought to patients rather than requiring them to travel to sites. This model is not yet widely available, but she believes it holds immense promise for expanding access and reducing barriers.
