Patient Reported Opinions about Clinical Tolerability

PROACT gives patients a way to engage with the clinical trial they are on, enabling real-time decision making during the trial. It is an innovative mobile app giving patients ‘a voice’ in clinical trials.

Developed in consultation with patients, PROACT allows patients to record personal video, audio, or text messages in addition to their standard case record data. They can report how they are feeling and functioning while taking part in a clinical trial, including ‘real-life’ insights about how adverse events affect them. This is helping to transform the way that patient data in clinical trials is collected.

 

It gives physicians and scientists a much deeper and more meaningful insight into how an individual patient is tolerating a new drug. This rich seam of real-time information enables better-informed decision-making, as fast as possible, so that one of three crucial decisions can be taken:

  • The trial should be stopped
  • The trial can continue as planned
  • The trial design needs adapting to better suit the patient

Valuable patient insights

PROACT has already provided valuable patient insights that could otherwise have impacted on drug development. For example, a commonly reported rash associated with one investigational medicine which could have slowed drug development was rapidly shown to be tolerable and self-limiting thanks to patient reports via PROACT. In another video, a patient reported that a medicine tasted unpleasant, even though it was only in their mouth for a few seconds. The drug formulation team assessed this information, to consider that adding a flavouring might mean more patients stay on the treatment in the future.

Patient input via PROACT not only contributes to drug development, but also enables better compliance from patients likely to be taking the drug in the years ahead.