The Cost of Clinical Trials

[RandyW]

The Cost of Clinical Trials

Robert Fee, Managing Editor

Twenty five billion dollars can buy an awful lot. With that much money, you can bail out the insurance companies from Hurricane Katrina-related claims, or perhaps, you could buy your own computer manufacturer. Or, you could fund nearly every clinical trial completed in the United States in 2006.

Clinical Trials in the News

• Gemin X begins recruiting patients for its phase I trial, Safety and Efficacy of Obatoclax Mesylate (GX15-070MS) for the Treatment of Hematological Malignancies.

• Johns Hopkins University announces plans to study the effects of several ocular drugs (Bromfenac, also called Xibrom; Nepafenac, also called Nevanac; Ketorolac tromethamine, also called Acular LS) for the treatment of swelling in the retina (the light-sensitive tissue in the back of the eye) called “macular edema” that occurs after cataract surgery.

• Pemetrexed, Gemcitabine, and Bevacizumab in Treating Patients With Stage IIIB or Stage IV Non-Small Cell Lung Cancer, a study conducted by the National Cancer Institute, is now looking for patients.

• Novartis is running a phase II trial testing the effectiveness of Cyclosporine A microemulsion for chronic plaque psoriasis.

• Bristol-Myers Squibb and Massachusetts General Hospital collaborate on a phase IV trial covering Aripiprazole treatment for generalized anxiety disorder and panic disorder.

• Roche and Kosan initiate phase II cancer development program with epothilone R1645.

• GlaxoSmithKline starts an international phase III trial of its investigational cancer treatment TYKERB (lapatinib) in squamous cell carcinoma of the head and neck.

• Pfizer is assessing the impact on glucose control by inhaled insulin in patients with type 2 diabetes who are not well controlled on two or more oral anti-diabetic agents in a phase III trial conducted with Sanofi-Aventis.

Clinical trials are, of course, necessary, but they come with a staggering price tag. On average, pharma companies are spending anywhere between $100 and $800 million per drug candidate. Given this climate, drug companies are looking for cost-saving measures. Sure, pharma companies bring in a lot of money, but they also have to spend a huge chunk of it, too.

CMSInfo, Chesam, UK, reports that national spending on clinical trials in the United States was nearly $24 billion in 2005. Results are forthcoming, but the research institute expects this number to rise to $25.6 billion in 2006 and $32.1 billion in 2011—growing at an average rate of 4.6% per year. The number of clinical trials performed in 2005 was 8,386. BCC Research, Wellesley, Mass., predicts this number will reach almost 10,000 by 2006. At a growth rate of 5.8%, the number of clinical trials performed in 2011 will reach more than 13,000. Research companies are predicting huge growth in this market, but it is clear that life science companies need to find a way to decrease these costs if the industry is to fund all those trials.

There are ways to save. Carol Rozwell’s, Gartner Inc., Stamford, Conn., report covering clinical data standards found that, “clinical data standards, such as those offered by the Clinical Interchange Standards Consortium (CDISC), can improve processes in a single clinical trial that result in an estimated eight-month cycle time reduction in study startup, study conduct, analysis, and reporting, which equates to a $9 million cost saving.” The study continues by predicting cost savings between $7.5 billion and $8.7 billion annually by 2010 if clinical data standards are used to improve clinical trial efficiency—a huge cost savings, and just one way to reduce a huge expense.

Rozwell contends that most biopharmaceutical companies are spending more money and taking more time to complete clinical research than is necessary and lack the performance metrics to evaluate R&D investments in clinical study.

“The greatest opportunity for improving overall clinical study performance,” writes Rozwell, “accrues when CDISC standards are used in study startup, because the value propagates throughout the other stages of development.”