The U.S. FDA has implemented various programs that help to deliver safe and effective therapies to patients in need. These programs cover a broad spectrum of topics and provide additional pathways and/or support for innovative science. In this blog, we’ll discuss several important and well-known programs and their impact on research and development. Accelerated Approval
As long as their trials are well-designed and based on prior data, safeguard participants, and meet all current federal standards, drug developers have wide latitude in clinical trial design. Though clinical trials still largely follow traditional designs, some notable advances made over the last two decades are having a positive impact on drug development. Traditional Trial Design
What’s the background on eCRFs? Electronic case report forms (eCRFs) are used for gathering patient data during clinical trials. They play a crucial role in helping to assess the safety and efficacy of clinical products. For a study to be successful, data collected must be correct and complete. To be correct and complete, forms must be well planned
Marvin Direct empowers virtual interaction between investigators and their patients as personal contacts are still limited We are proud to announce the release of Marvin Direct, a GDPR-compliant video chat app to facilitate communication processes in times of COVID-19. As personal meetings between patients and their investigators at research sites and hospitals are
In the early 20th century, the scientific community advocated for the use of “well-controlled” therapeutic drug trials. These relied on laboratory analysis followed by clinical testing in animals and humans. But the development of these drug trials was helped along by some of the darkest episodes in the history of (bio-) pharmaceutical and medical research. Elixir Sulfanilamide and the
Change is the only constant in clinical research. New data sources, new data types, and new trial designs that open up new opportunities for data analysis are emerging. These changes reflect a movement in clinical research toward the development of more targeted therapies. As we embrace the concept of precision medicine, also referred to as individualized,
Clinical trials are crucial in advancing human health and the practice of medicine. From early drug discovery to late stage clinical studies and post approval, the clinical trial process continues to evolve. This evolution of clinical trials offers insight into current regulations, trial designs and practices in clinical research. Early Trials The first historically recognized
