Rare disease clinical trials pose challenges above and beyond those encountered in trials involving more common conditions including: very few patients being available for clinical trials, those who are available are often geographically dispersed, lack of knowledge and data about a particular rare disease, the amount and quality of data generated by small-scale trials and the need for multi-site, multi-country trials requiring regulatory expertise in a number of regions. Cromos Pharma’s Head of Start-Up, Mikhail Kamkha, MD, MRQA outlines some of the specific considerations necessary to improve the chances for success in rare disease drug development:
Be where the patients are and expert study planning
Partnering with a CRO with a strong track record in innovative trial design, exceptional multi-country patient recruitment and proven regulatory expertise is vital.Cromos Pharma is an international CRO with 16 years of experience in managing all aspects of clinical trials across all phases in a wide range of therapeutic areas. Our team has managed several rare disease clinical trials and can provide your next study with the support and expertise to help ensure success.
Tuesday 1 December marked World AIDS Day 2020. Although throughout this year our focus has been on the coronavirus pandemic, World AIDS Day is an opportunity to reflect on another pandemic where a virus passed from animals to humans with devastating consequences. To date 77 million people worldwide have been infected with HIV. In spite of innovative new treatments 35 million people have died from the virus.
If you missed the live webinar “Where in the world should I locate my pivotal clinical trial?” you can now watch the recording by clicking here. The webinar hosted by the Society of Physician Entrepreneurs (SoPE) and Workforce Genetics features Cromos Pharma's CEO Vlad Bogin, M.D, FACP.