Achieving the shared goal of bringing safe and effective new medicines to patients
Collaboration among all stakeholders needed to improve drug development and optimize expanded access
05.30.14 | By Sascha Haverfield, Ph.D.
Each patient facing a life-threatening disease lives with the hope that tomorrow will bring a new medicine to extend and improve his or her life. As a scientist, a new father, and as someone who lost a parent to stage IV lung cancer far too early in life, it is gut-wrenching to admit that modern drug development continues to be a highly challenging and far too often unsuccessful endeavor.
The drug development process is long, costly, and uncertain. It takes on average 10-15 years to develop a new, safe and effective medicine despite all of the scientific breakthroughs and discoveries of the past 30 years. This is largely due to our still incomplete understanding of human biology and the many, many complex factors that contribute to human disease.
So how can we achieve our shared goal of bringing innovative new medicines to patients as quickly as possible? Clinical trials are the best way to ensure that safe and effective medicines are available to patients in need. After all, successful completion of the clinical trials process is necessary to demonstrate that an investigational drug is safe and effective, which is required to obtain approval by the U.S. Food and Drug Administration (FDA) so that a new medicine can be made available to a broader patient population.
We can all understand that patients who face a serious or life-threatening disease want to pursue every possible treatment option. I can say with certainty that the biopharmaceutical industry is committed to helping patients and physicians understand and navigate the complex clinical trial process and the full range of treatment options - whether that be a clinical trial, an FDA approved medicine, or – when appropriate - expanded access to an investigational drug.
In order to achieve our shared goal of bringing safe and effective medicines to patients as quickly as possible, we all – patients, physicians, FDA, industry and academia - must come together to identify ways to improve clinical trials and drug development and to optimize the federal expanded access process.