A Global Pharmaceutical Company – Subject information and the informed consent procedure within clinical trials

Client challenge

An audit of the clinical trial ‘supply chain’ highlighted new areas of risk, particularly in relation to the conduct of trials and information provided to patients (‘subjects’). The client needed to ‘de-risk’ itself in this area, but in a way that put the subjects at the heart of the process, rather than the scientists and researchers.

The key to unlocking the issue in this project was to involve stakeholders from across the drug development and clinical trial “supply chain”, including members of clinical pharmacology teams at a leading pharmaceutical company, “investigators”, “key informants” such as ethics committee heads and opinion formers in the world of medicine and actual patients and volunteers who take part in clinical trials.

What did we do?

The process of “dialogue” took place over a 12 month period, with a key informant phase, followed by a problem definition phase, and culminating in an action planning phase to create the basis for action and a pilot phase to improving the way the client carries out and records the informed consent process.
 
Article 13 ran an initial participative audit of the clinical trial “supply chain” with members of the company’s clinical trials team and as a result the group were able to identify new and previously unmeasured areas of risk. The main risk or area of uncertainty identified was that of ‘understanding’. It was clear that a new approach was needed to check if the current regulation and legislation went far enough or if the client needed to take a leadership stance on this issue which was effectively one of ‘governance’. A process of dialogue and participative research was designed. This aimed to explore what the current industry issues were in informed consent. The initial phase consisting of key informant interviews and literature review highlighted that subject understanding was an area of concern.

The second phase of the process involved participative workshops with drug development teams, investigators, patients and volunteers. With each group, we explored their experience of the informed consent process and their needs and concerns. The findings of these workshops were fed back to the original team at the pharmaceutical company. They used the findings to formulate an action plan for the company and its sub-contractors on a new and enhanced process for conducting informed consent.

How did we break the cycle?

Participative workshops were the tool of choice, to enable the development of policy that put subjects at the heart of the process.

© Article 13 2005