This week is Clinical Trials Awareness Week — an annual event to recognize the important role clinical trials play in helping develop safe and effective medicines.
As the biopharmaceutical industry innovates and introduces cutting edge treatments and cures, clinical trials are changing too, which is good news for patients. New approaches to designing clinical trials can not only streamline the drug development process, but can also increase patient involvement in the research and development process, enhance awareness and improve participation.
Active participation from patients in the full spectrum of clinical trial development and design can yield important insights on disease burden and inform the development of novel clinical endpoints. One way researchers are collaborating with patients and patient advocacy groups is the identification of patient-focused study endpoints and design features. Advancements in technology are also enabling new drug development tools such as biosensors, electronic patient diaries and apps to help make participation more convenient, while allowing patients to contribute information directly.
Advances in clinical study design are also impacting the research and development lifecycle and facilitating earlier access to new and potential treatment options for patients. Complex clinical trial designs enable studies to evolve as more information is gathered, creating efficiencies that can streamline drug development time. Similarly, expanded clinical data analysis techniques can help monitor patients’ responses to treatments and make clinical development programs more efficient.
Additionally, new highly targeted treatment approaches such as cell and gene therapies are able to target diseases that previously had few treatment options. Clinical studies with these types of treatments use novel study designs to identify the right patients for treatment and increase the “signal to noise” ratio.
The biopharmaceutical industry is responsible for the vast majority of clinical research, accounting for nearly 90 percent of all spending on clinical trials of medicines and devices. However, we know that we can’t do it alone. We are thankful for the participation of patients in clinical trials and are committed to leveraging innovations to ensure patients involved in clinical research feel represented and supported.
Learn more about current innovative clinical trials here.
Richard Moscicki, M.D. Dr. Moscicki serves as executive vice president, Science and Regulatory Advocacy and chief medical officer at PhRMA. He joined the organization in 2017 after serving as the Deputy Center Director for Science Operations for the U.S. Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) since 2013. While at FDA, Dr. Moscicki brought executive direction of Center operations and leadership in overseeing the development, implementation, and direction of CDER’s programs. Previous positions include serving as Chief Medical Officer at Genzyme Corporation from 1992 to 2011, where he was responsible for worldwide global regulatory and pharmacovigilance matters, as well as all aspects of clinical research and medical affairs for the company. He served as the senior vice president and head of Clinical Development at Sanofi-Genzyme from 2011-2013.