The US Food and Drug Administration (FDA) has speeded up its review and approval of new drugs, but the complex nature of diseases for which new treatments are being developed is resulting in longer clinical development times, says the Tufts Center for the Study of Drug Development (CSDD) at Tufts University in Boston.
The average time for the FDA to approve new drugs declined to 1.1 years during 2005-7, but longer average clinical phase time means combined clinical and approval time continues to hover around eight years, the Center’s researchers report, pointing out that similar trends hold true for drug development elsewhere in the world.
The FDA recently reported that it approved 25 novel treatments last year, a considerable improvement on 2007’s total of 19 in 2007 and the highest number since 2004.
“Even though the total time to bring new drugs to market has remained essentially unchanged in recent years, drug developers are making progress,” said Tufts CSDD director Kenneth Kaitin. “Many factors are leading to longer clinical times, including a focus on complex diseases and more complicated development design protocols,” he added.
Drug companies have taken steps to speed clinical development, including improving project management, expanding use of partnerships and licensing arrangements, and increasing use of surrogate endpoints and adaptive clinical trials.
Nevertheless, “in drug development, the race - and rewards - go to the swiftest and most efficient drug sponsors, those that can deliver safe and effective new medicines in the shortest time,” said Dr Kaitin.
Even before the financial market downturn, nearly all public-traded drugmakers were under enormous pressure to bring new drugs to market faster and at less cost. That pressure has only increased, making the challenge to companies going forward “crystal clear” – align with the best people and employ the best technology behind the most promising new drug candidates, says the Tufts CSDD’s newly-published Outlook 2009 report.
Outlook 2009 also makes a number of other forecasts for near-term trends in the industry, including:
- drugmakers will continue to globalize their preclinical and clinical development activities in order to overcome local capacity constraints, speed up the up the time it takes to get their products to market and expand their presence in emerging markets;
- the FDA will still struggle to fulfil its mandate, hampered by problems including ongoing shortages of experienced personnel, especially among upper-level managerial staff, and with advisory committee vacancies depleted by new conflict of interests and public disclosure rules;
- the recent trend towards more candidates entering clinical trials each year enhances prospects for new monoclonal antibody (MAb) approvals. Currently, 22 MAbs are available in the USA and more than 200 are in the pipeline worldwide;
- US payers, including health insurance companies and managed care organizations, will increase their use of formulary management tools to contain costs, particularly with regard to specialty pharmaceuticals; and
- demand for services from contract research organizations (CROs) will increase more than 15% annually, as sponsors face capacity constraints and a rising volume of large, complex global clinical trials.
