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