Clinical Research at a Crossroads
Efforts to improve the efficiency and safety of the clinical trials process have been underway across multiple sectors of the clinical trials enterprise for several years.
These have included international and regional initiatives by regulatory bodies and other organizations to harmonize operating policies and procedures for ethics committees; guidance for data monitoring committees; national regulatory frameworks; electronic case report forms; standards for electronic data capture; clinical trial agreements; and training and education of research teams, to name a few.
Financial Costs are burgeoning. Of the $70 billion the industry spends every year, 30% is wasted through inefficiency and redundancy–every year over $20 billion is squandered, while the cost of bringing a new drug to market soars, current estimates ranging from $1.5-$5.5 billion.
Despite improvement efforts, dysfunctions remain and are evident in the dismal annual statistics regarding costs, time, inefficiencies, waste, fraud and ethical lapses:
- Delays are costly. Time to market for a new drug is now averaging 12 years, ranging from 10-15 years and less than 20% of trials are actually completed on time.
- Failure is common: only one in 5,000 compounds tested will be approved as a new drug; 95% of promising new entities entering clinical trials fail to prove both safe and effective.
- Waste and inefficiency is pandemic: only 1 in 3 sites will enroll more than 1 or 2 patient-subjects, and 10% will enroll none at all. Over 2/3 of sites will only conduct one trial and then, due to costs, lack of training, inadequate access to trials, etc., will leave the clinical trial enterprise, never to do another trial despite all of the time, money and energy invested.
- Fraud is all too common: as a result of repeated scandals, ethical lapses, drug recalls due to suppressed negative trial data, exploitation of vulnerable populations andscandals involvingdata-fabrication and illegal marketing practices, the public’s confidence in the pharmaceutical industry hovers above rock-bottom, around a mere 11%.
- Greed is widely presumed to be the primary driver of the industry. While companies pursue “me-too” and “life-style” drugs, neglected diseases languish and 80% of the world’s population lacks access to needed medicines.