Dampening the enthusiasm

There were two lessons from last week's brouhaha over the data from a Phase II trial of Onyx Pharmaceuticals Inc.'s BAY 43-9006 in renal cell carcinoma. First, companies need to consider carefully whether and how additional data can be extracted from a trial once it is set. Second, trial investigators can be more enthusiastic about the interpretation of data than a set of independent eyes.

The trouble began when one piece of the final data was so different from the interim results that the company and partner Bayer AG said they wouldn't be able to submit the Phase II study for FDA approval, as they had previously hoped would be an option. Instead, a

Read the full 1136 word article

User Sign In

Article Purchase

This article may not be distributed to non-subscribers

PURCHASE THIS ARTICLE FOR LIMITED ONE-TIME DISTRIBUTION AND WEBSITE POSTING $995.00 USD

PURCHASE