1. The industry sponsor and the investigators should have a firm commitment
to thorough monitoring of the trial at every step.
2. All data collected in the trial should be open to scrutiny by both
the investigators and the industry sponsor.
3. Clinical investigators should have substantial input into the initial
analytic plan and also any subsequent amendments that occur during the
trial period.
4. When possible, statistical analysis of the data should be conducted
by an entity independent of the researchers and the sponsor. For trials
using interim analysis, use of an independent entity is particularly
important. Decisions to prematurely stop a trial should be based upon
predetermined criteria.
5. Consideration should be given to the use of an unbiased, blinded
“clinical evaluation committee” for trials that involve
assessment of potentially subjective endpoints.
6. The industry sponsors must share the results of all data analyses
with the principal investigators. Selective withholding or incomplete
reporting of data analyses to the principal investigators is unacceptable.
7. Trial results and data analysis should be shared with the principal
investigators as soon as they become available. Delays by the industry
sponsors for marketing or related purposes are unacceptable. (PDF)