Medical Review of Clinical Trial Data: preparing for interim analysis

The Problem

A Phase III oncology blinded randomized controlled trial was heading towards an interim analysis when the study team realized they needed support to check the data for accuracy ahead of the database lock (DBL).

High Potential

This interim analysis had been incorporated into the study design at a time when the potential benefits of the product were not specifically known, but since then, data from other studies had been received. This showed that the results from this trial had the potential to demonstrate a significant difference between treatment arms, even at this stage in the study.

The final analysis was not due for another year and the trial was still recruiting, with many patients in the active treatment phase. This was a very busy time for the study team with lots of ongoing data entry and queries from the CRO and investigator sites.

New Pressure

The pressure on the medical team suddenly increased when they were told that there was the potential to result in submission of a marketing approval application if statistical significance were observed at this data maturity. This meant that they needed to prepare for this interim database lock as if this were a final analysis. Data quality was therefore a critical factor, as there would be no opportunity to make corrections, added to the fact that the data needed to be entered accurately to facilitate a robust analysis.

Request to Pharmora

The team reached out to Pharmora to ask if we could support the review of almost 250 subjects with 5 weeks to go before an increasingly impossible DBL date.

The Solution

Pharmora provided a team of medical scientists to support the client’s medical team with data review. As time was of the essence, Pharmora assigned scientists who had relevant experience with the type of study and the specific client so that they could get very quickly up to speed with the new project.

The Pharmora scientists performed a detailed medical evaluation of the individual data points to identify any inconsistencies for the subjects assigned to them. The Pharmora scientists supported each other, drawing on expertise from within the organization for any learning points to avoid using up the client’s time while they got up to speed.

Pharmora raised suitable queries, utilizing the client’s database, following them up by email with the local CRO staff or investigator sites directly where applicable. Pharmora also helped in many other ways as requested by the client’s medical team during this period. Any potential issues were communicated immediately to the client’s medical team, giving them full visibility of the ongoing data reviews while allowing them to focus on their other tasks.

The Outcome

Due to the support from Pharmora the DBL for this interim analysis was delivered on time, with a high level of accuracy in the data, and the result was positive!