Saturday, May 23, 2009

All professionals have conflicts of interest. The real issue is whether these will lead, or have led, to bias, and if this bias will affect the study design, conduct of the study, data analysis or interpretation of the data.

Seeking to find people without a conflict of interest is foolish. It is more critical to assess their degree of bias, based on past publications, speeches and other information. Even having a pet theory to support often leads to bias in viewing scientific proposals or publications from others.

Data analysis and interpretation of data are two separate processes, even if they are conducted 30 milliseconds apart by a single person. Data analysis and statistical interpretation, however, is usually conducted by a statistician and clinical data interpretation by a scientist or clinician.

A clinician is the only one to determine clinical significance, while a statistician determines statistical significance. Of course, a clinician who is trained in statistics can also conduct statistical analyses and interpretations.

Friday, May 15, 2009

Sunset clauses for all discovery projects are a useful means to ensure the company reviews progress on each project to confirm that it should be continued. These reviews may occur every two years or at other pre-assigned times.

Are your company's public statements being followied in practice? If not, try to reconcile the two or it is likely to negatively affect staff morale.

Using higher medical and scientific standards than required often trumps the competition, as they will be trying to take some shortcuts,or follow a traditional development pathway; and; the FDA and/or other regulatory agencies will observe your standards as being improvements, and will raise the bar for marketing approval. Your competitors will be required to use the same standards you have employed and thus be set back in their work.

Wednesday, May 6, 2009

To read without reflecting is like eating without digesting. Edmund Burke (UK politician)

Obstacles are those frightful things you see when you take your eyes off your goal. Henry Ford (founder, Ford Motor Co.)

The sign of a good intellect is the ability to keep two contradictory ideas or thoughts in your mind at the same time.

It makes no sense to leave potential problems outside your plans if they have a reasonable likelihood of occurring.