Streamlining Clinical Trial Strategies
Clinical development strategy experts today face the challenge of shortage of patients for their clinical trials. There is a growing trend of this problem in the industry forcing biotech companies to re-think their strategies for the clinical trials.
Research indicates that the primary reason for this challenge is that many biotech companies today follow the strategy of selecting diseases for trials based on current clinical trends - diseases that are popular. That makes a lot of biotech companies competing for the same pool of patients with the same disease.
Another factor playing an important role in this problem is the increasing stringency of the FDA. String rules from FDA mandating more specific patient populations for more refined end points, decreases the patient pool for every clinical trial. The criteria patients must meet for trials have reached the point that it is impossible to find a significant number of patients at a moderate number of sites. Exacerbating the problem is that the limited number of patients who possess the necessary attributes is spread across the numerous companies conducting similar studies.
How can we solve this problem? We believe that the evaluation of the product's mechanism of action and product strengths must direct the medical, clinical, regulatory and marketing experts to focus on the appropriate target disease and patient population to develop a successful development strategy with realistic timelines and budgets. The development of a successful strategy is a complex balance of key elements which must integrate
- Medicine: Disease and patient variabilities; knowledge of the product efficacy and safety potentials
- Regulatory: Requirements according to the therapeutic areas and the regulatory authorities
- Market: Presense of competitive treatments; history and characteristics of competitive treatments.