Stretching the Clinical Dollar

It seems that we are being bombarded with messages lamenting the economic downturn and the corresponding needs of virtually every industry to “trim costs” or “preserve capital.” As the access to funding has become increasingly difficult, the intensity of Clinical Operations and Board Room discussions of “stretching” the research and development budget has intensified.

The facts and challenges are staggering – developing a drug from bench to market can cost upwards of a billion dollars; hospitals, physicians and patients rely on the research dollars provided by pharmaceutical companies, in terms of direct payment and “free” patient care to make budget ends meet; regulatory hurdles continue to rise with each new “Vioxx” as the FDA seeks more safety data generated over longer periods of time; the cost to send clinical staff to more remote clinical sites rises astronomically.

With this backdrop, is it even feasible to discuss “stretching” the clinical dollar?

It seems a daunting task – and there is no Sunday circular from which to clip coupons to help save an extra 15% on data management costs. So what can our industry do?

With all challenges come huge opportunities. A greater level of scrutiny on spending in clinical trials is an excellent reason to take steps to ensure we are doing the right study. A few cost saving steps that come to mind are: ensuring the data collection process is streamlined to maximize monitoring visits thereby limiting travel and personnel costs; or ensuring that contracts are negotiated with providers (CROs, labs, etc) with enough detail to limit out of scope charges and changes. As an industry we like to think that more data is better, but more data usually equates to greater cost. Perhaps we should consider building mechanisms for more thorough analysis of data we collect in the clinic so that additional studies are not necessary. (As more studies = more money spent).

Bottom line: we need more disciplined practices in clinical development and decision making to stretch the clinical dollars further.