Clinical Trials Modernization Initiative
Leveraging modern advancements in molecular biology and genomics, the Biotechnology Industry Organization’s (BIO) member companies have pioneered innovative and lifesaving treatments for patients worldwide. These therapeutic and diagnostic products are leading to significant improvements in the care of patients with serious diseases – in many cases providing the first approved treatment for a condition. However, despite significant investments in the discovery and development of modern therapies and treatments, recent reports have noted that the overall efficiency of pharmaceutical research and development (R&D) efforts has been declining steadily for more than 50 years. While many factors have combined to cause this overall decline, it is widely recognized that the increasing timelines and costs associated with clinical trials are key contributors to this problematic trend.
In an effort to bring innovative new medicines to patients more efficiently, while protecting and enhancing patient safety, BIO is developing an initiative to modernize clinical trials. The key goals of this initiative are:
- To identify the key issues driving increases in the cost and duration of clinical trials and prioritize the specific issues that are most important and impactful to BIO members;
- To coordinate and enhance ongoing efforts by external initiatives and public-private partnerships that are working to address priority issues; and
- To build support and advocate for specific, science-based policies to modernize the conduct of clinical trials.
Confronting the problem of increasing costs and durations of clinical trials in a meaningful way is a daunting task. BIO is committed to working with members and other stakeholders to create a prioritized, actionable list of issues to address, and then to reducing redundancies and inefficiencies by engaging and empowering partnership enterprises that are already making significant progress toward improving the conduct of clinical trials. More efficient clinical trials translate to reduced barriers to market for safe, innovative medicines, which is the ultimate goal of patients and manufacturers alike.