“Give the patient a voice when re-organising clinical regulatory practice,” DIA’s global and European directors urged.
Speaking to Outsourcing-Pharma at this year’s DIA (Drug Information Association) Euromeeting, European director Brigitte Franke-Bray and worldwide executive director Paul Pomerantz said the patient is fast becoming an equal stakeholder in the pharmaceutical business.
By listening to patient organisations, they said, the other silos can get a much needed fresh perspective on the decision making process. Franke-Bray said: “They (the regulators) have to come together. And I think they also have to give a voice to the patient, and we are now seeing that.”
She cited the DIA’s involvement in the recently launched consortium EUPATI (European Patients' Academy on Therapeutic Innovation) as an example of the kind of “new wave” forum the industry should work towards in the future.
The academy is aimed at educating patient representatives in the design of clinical trials and regulatory matters, as well as improving ties between the four major stakeholders: the regulators, industry, academia and now, the patient.
She said: “We have had a patient fellowship program since 2006 and a good relationship with patients through that program, but we have never really been exposed into direct discussions with patient organisations.
“By having come into this consortium it opened to the doors to hear a lot more and to hear a lot of different views that had been unknown to us before then. It’s a different angle and it has broadened our views again. We came down a level.”
Things to come
The DIA is now pushing for more measures which will help solidify patients as the fourth stakeholder.
Pomerantz said: “Patient organisations are very involved with DIA. Based on our patient fellowships in Europe, and our leadership in the EUPATI program we now have a fellowship in North America.”
Franke-Bray added that the association is also currently hoping to work with a new program similar to EUPATI, but focused on clinical research in India.
“Patient involvement is spreading even into India,” she said. “It’s much more difficult in a country likeIndiathanEurope, but it is happening. The patient everywhere wants more rights and power.”