Research Does Not End at Medicines Approval

Research is a critical part of the development of new medicines, but it doesn’t stop once the medicine is approved by the U.S. Food and Drug Administration (FDA).  In fact, that’s when post-approval research and monitoring begin and they help all health care stakeholders, including physicians and patients, to better understand the full value of the medicine. Today, PhRMA released a new video about the importance of post-approval research, featuring Dr. Tim Garnett, Chief Medical Officer of Eli Lilly & Company.

Post-approval research utilizes data produced in the practice of medicine, including from patients, providers and payers. This information is known as real-world evidence (RWE) and it helps physicians, patients, payers, health authorities and biopharmaceutical companies better understand the medicine and its appropriate use. Assessment of RWE could lead to the discovery of new potential uses for the medicine and/or to a greater understanding of how the medicine can work with other therapies to deliver greater benefit to the patient.These findings can lead to expanded treatment options and mean greater hope for patients. For example, medicines initially developed for use in rheumatoid arthritis have been shown to also help treat other autoimmune conditions that share similar molecular pathways, including Crohn’s disease and ulcerative colitis. The same is true in cancer research. Oncology therapies often have clinical value in types of cancers distinct from the original indication(s) for which they are approved. Studies conducted and reported after the initial approval commonly explore additional indications and, in many instances, a therapy demonstrates significant clinical benefit in a different disease.

In addition to post-approval research, biopharmaceutical companies and the FDA have systems in place to ensure patient safety by monitoring medicines for adverse effects, as reported by patients, health care professionals, and others.

by: Andrew Powaleny