This week is Clinical Trials Awareness Week — an event to recognize the importance of clinical trials, raise public awareness of clinical research and honor clinical research professionals and importantly, volunteer participants for their roles in helping to develop safe and effective medicines.
The biopharmaceutical industry sponsors thousands of clinical trials each year to assess the safety and efficacy of medicines, vaccines and other therapies. Instrumental to these carefully designed studies is patient participation. According to most recent data, industry-sponsored clinical trials engage over 920,000 volunteers yearly to assess effectiveness for devastating conditions, like Alzheimer’s disease, rare diseases and cancers.
During times of global public health emergencies, like the current COVID-19 pandemic, clinical researchers must work rapidly to test investigational medicines that can potentially treat patients and identify possible vaccine candidates that could prevent the disease. At the same time, clinical researchers also need to assure the safety of participants in ongoing clinical trials for other diseases. COVID-19 has led to unprecedented challenges in clinical research due to quarantines, study site closures and travel limitations. The biopharmaceutical industry is leveraging scientific advancements and is closely collaborating with U.S. and global health authorities in our quest to beat COVID- 19 and ensure clinical research continuity. Here is a closer look at four critical aspects of clinical trials.
Clinical Development Advances
Biopharmaceutical companies have been employing the latest scientific and technical advances to streamline the clinical research process and create efficiencies that improve participant experience. Given travel restrictions associated with the current pandemic, technical advances in clinical trial design and conduct have been essential to the continuity of existing trials. For example, adaptive trial designs and digital health technologies such as wearables, real-time monitors and digital diaries have enabled virtual site visits, monitoring, data capture and increased communication and patient connectivity by phone or video chat. This is commonly referred to as a form of telemedicine.
Rapid COVID-19 Response
As of May 14, 2020, there are 876 clinical trials underway for potential COVID-19 treatments and vaccines. Advances in clinical trial approaches have given biopharmaceutical researchers the ability to find creative solutions to move promising potential treatments and vaccines forward quickly, safely and efficiently. In doing so, many researchers are exploring ways to enhance efficiencies in the clinical trial process, such as by accelerating early phases of clinical research and completing some parts of the clinical trial simultaneously, using master protocols to evaluate multiple therapies in a single study and sharing data and study results to speed up clinical development. Biopharmaceutical companies are also collaborating with each other and U.S. and global public health authorities, including the U.S. Food and Drug Administration (FDA), the National Institutes of Health (NIH) and the Centers for Disease Control and Prevention (CDC), as well as the World Health Organization (WHO), among many others, to address this public health crisis.
Critical R&D Partnerships
Public-private partnerships are powering continuity in clinical research. These partnerships are critically important as academic medical centers and government institutions help run some clinical trial sites. A recently announced public-private partnership, Accelerating COVID-19 Therapeutic Interventions and Vaccines (ACTIV), is working to advance solutions for COVID-19 through streamlining clinical trials and coordinating with regulatory bodies. The partnership brings together more than a dozen leading biopharmaceutical companies, NIH, FDA, and other stakeholders, as coordinated by the Foundation for the NIH (FNIH), to advance the rapid work already underway. Public-private partnerships and close collaboration among stakeholders create the capability to respond quickly to the threats and innovate amid a global crisis.
Robust Patient Participation in Clinical Trials
While scientific innovations, biopharmaceutical companies’ efforts, and public-private partnerships are critically important to the continued advancement of clinical research, none of it would be possible without patient volunteers. The FDA is encouraging more patients to participate in clinical trials, especially people of different ages, races, ethnic groups and genders.
Clinical researchers and patient participants are the unsung heroes of medical advancements and we are proud to recognize their contributions. Read more about how clinical trials work here and how the biopharmaceutical industry is combatting the COVID-19 pandemic 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.