The Background

A Phase II trial with a new oncology product had an unexpectedly fantastic result, years in advance of the Phase III studies reading out.

The project leaders wanted to use this Phase II trial as a pivotal study to submit an application for marketing approval, rather than waiting for the Phase III data. Combined with data from other studies including another Phase II trial, the results from this study were strong enough to support a marketing licence, which meant the product could be available for patients with cancer to benefit from within a few short months.

The Problem

Although this seemed like fantastic news, the clinical project team were faced with a dilemma: they were not prepared for a submission to regulatory agencies, as this involves analysis of data across the entire study project. The clinical project team had expected to wait until Phase III studies were completed before they needed to conduct such an integrated analysis. They did not have enough staff assigned to the project at that time to manage the huge workload associated with a submission, and finding suitable internal personnel to support them would risk a substantial delay.

The Solution

One of the elements Pharmora was asked to help with was signal evaluations. This meant summarising all available information surrounding specific new adverse events to help the client decide whether or not to add the event to their list of expected adverse drug reactions (ADRs). A batch of new safety signals arising from the integrated analysis of safety data across the project was outsourced to Pharmora and we were given the client’s templates.

Pharmora assigned a team of safety scientists and medics and began to prioritise the signals for review. The Pharmora team conducted literature searches and reviewed data from many sources to inform their summaries. Pharmora provided the populated templates for each signal to the client, highlighting key elements of the evaluation in the covering email to enable the client to prioritise those with the potential to become newly identified ADRs.

The Outcome

All signals were evaluated and returned to the client in plenty of time for them to compile the list of expected ADRs in the Company Core Data Sheet in addition to all the rest of the necessary documents. This led to a successful marketing approval, bringing another treatment for cancer to patients who will benefit from it.