Independently reviewing clinical trial data

Challenge:

A small biopharmaceutical company asked us to provide an independent review of data from a recently completed clinical trial. We were to provide a summary report for the company’s management and board of directors.  Due to an upcoming board meeting, this request had a tight deadline of only six days from the initial transfer of data to submission of the final report.

Solution:

Our medical oncologist, who had more than 20 years’ of industry experience in clinical development, led the project.

Our report included analysis of:

• the study population, baseline characteristics and imbalance between treatment groups
• patient disposition by treatment group
• drug exposure, adverse events and safety in each treatment group
• primary and secondary efficacy endpoints
• performance of the control arm in various subgroups, and relative to historical data
• treatment effect in various subgroups, potential confounding variables and interpretation of Cox proportional hazard models

We also provided recommendations on:

• additional statistical analyses of the data set, new clinical studies that the company may want to consider
• potential next steps with the FDA and other health authorities
• potential implications for the company’s discovery platform

The report was prepared and sent to the company 24 hours before the deadline which allowed the company’s management team to review and send follow-up questions. We answered, including providing additional data analyses, within three hours, allowing the management team to have the information prior to its board meeting. The company’s board used this information to help them set direction for the company.