With the most comprehensive survey of clinical success rates across the drug industry to date1 suggesting productivity may be even lower than previous estimates, and other sources quoting failure rates at over 90% for Alzheimer’s drug trials, it is easy find fault with the current clinical trials model. Yet viewed from another angle, the approval rate for new molecular entities and drug applications filed with the FDA has remained fairly constant over the decade,2 so the industry must be doing something right.
The drugs being developed today are targeting many of the least understood, most difficult to treat diseases
The drugs being developed today are targeting many of the least understood, most difficult to treat diseases. Many such drugs are often aimed at older patients, already undergoing several treatment regimes for multiple and complex diseases – diabetes, heart disease, cancer and Alzheimer’s, making end points difficult to achieve.
Some industry estimates suggest that clinical trials account for 40% of overall drug research costs and those costs are rising. A report from market research company Visiongain predicts that the world market for pharma clinical trial services will be worth US$30.6bn in 2015.3 But with fewer blockbuster drugs likely in the future, and growing price pressure from payers, it is important that pharma companies become more efficient and increase the success rate of clinical trials.
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