It’s not surprising that modern medicine is vastly different, and much improved, from even 15 years ago. The progress in treating many types of cancers and more effective HIV therapies are just two examples. Use of stems cells, improved tissue engineering, and many other discoveries are poised to continue this improvement. What is surprising to most, is the time it takes to develop a treatment. This process can take as long as 20 years, with many failures along the way. Developing any new treatment has to clear more hurdles now than ever before, such as outperforming existing treatments and increased FDA scrutiny.
Our lab’s work focuses on healing severe bone fractures. Despite many advances, complications and failed healing remains a large problem for orthopaedic patients – an issue that will only grow as our population ages. Therefore it is important for researchers understand what it takes to develop an idea into a treatment. An ideal treatment would work better than existing ones, with fewer side effects. Efficacy and severe side effects have, in fact, plagued orthopaedics for many years. The type of intervention being studied also matters immensely because of the differences in FDA regulations. For example, removing and replacing a patient’s own cells during the same surgery receives very little scrutiny. However, taking those same cells and expanding their numbers, then putting them back in the same patient (days/weeks later), is scrutinized much more closely. Finally, commercialization of a therapy is also vital because large and expensive clinical trials are often required for new therapies. Creating new therapies is expensive and therefore, often times requires the financial backing of investors.
While ideas generated in research labs serve as the seed corn for new medicines, the path is very difficult. Researchers who have an understanding of the many potential pitfalls are better prepared for success in translating their basic discoveries into better patient lives. We hope we are successful at translating our bone healing work into the clinic!
Written by Paul Childress
The views expressed in this content represent the perspective and opinions of the author and may or may not represent the position of Indiana University School of Medicine.