Improving the clinical trial process

That wouldn’t be a problem if it meant the industry was bringing record numbers of new drugs to market with speed.

By Editor on May 20, 2003

That wouldn'st be a problem if it meant the industry was bringing record numbers of new drugs to market with speed. However, the number of NMEs approved by the FDA has decreased from 35 in 1999 to 17 in 2002.

According to Datamonitor, among the various costs involved in pharmaceutical R&D, clinical trial expenditures represent the largest slice of the pie. In order to maintain productivity, companies must take measures in order to improve the efficiency and effectiveness of the clinical trial process to reduce R&D costs, Datamonitor advises.

There are two ways to approach cost cutting in the clinical trials process: cut actual expenditures and/or gain efficiencies in the process, allowing new drugs to reach the market faster. There's no magic pill for pharma's clinical trial ills, so addressing the problem of reducing costs and gaining efficiencies will require a variety of well-thought out approaches.

Pharmaceutical companies will need to reduce drug development costs by adopting different time and money-saving technologies as well as better practices, Datamonitor contends. Moreover, companies can improve the chances of FDA approval for drugs in their existing pipeline by enhancing the clinical trial process.

Let's face it, it's a tough balancing act between reducing costs and maintaining, or better yet improving, the quality of clinical trials. The featured case study in today's eyeforpharma Briefing on Novartis's use of e-patient diaries from CRF Box in a large, multi-national clinical trial demonstrates a slight direct cost savings, but more importantly a gain in efficiency and quality of data collection. Granted, it's just one example of improving the clinical trial process but it's certainly a good one.

In addition, to help you further investigate innovative ways to improve the clinical trial process, we'sre spotlighting a white paper, Unifying Clinical Informatics Applications, from Phase Forward and insight on utilizing Web-conferencing for investigator meetings from ePharmaLearning.