The human condition – PharmaTimes
How do we make rare disease clinical trials more human?
The clinical research industry is increasingly prioritising diversity in clinical trials, though it has been a slow process over decades of regulatory guidance, with the latest from the FDA in April 2022.
Despite the increased attention from regulators, diverse patient populations are still underrepresented in rare disease clinical trials – to the detriment of the patients and the research. For many rare disease patients, clinical trials are their only access to potentially meaningful therapies because only about 5% of the known rare diseases have approved treatments.
Broadly speaking, rare disease clinical research faces compounding barriers to achieving diversity in trials. We map these systemic barriers across four key levels: disease strategy, protocol, trial site and always the most critical level – the patient. There are various steps that sponsors, CROs, sites and patient advocacy organisations can take to drive progress toward representative trial populations.
Check out the rest of this feature here
Source link
#human #condition #PharmaTimes