When it comes to scientific research one of the most important voices, that of the patient or patient advocate, has often been one of the hardest to hear. But that is changing and CIRM is not only helping lead the way but also helping shape how, when and where those voices are heard. (Our board member Jeff Sheehy has blogged about this effort.)
Traditionally patients, patient advocates or lay members of the public were brought into the development of new drugs or therapies or technology towards the end of the process. Even then there was often just one or two members of the public on a large scientific panel and their role was frequently limited to approving or rejecting a new product or therapy. This had the effect of ensuring that the group which had the most to gain from the research often had the least to say about it.
In recent decades patient activists – such as people with HIV/AIDS or breast cancer – have demanded a bigger role in research. When CIRM was created Proposition 71 specifically called for 10 of the 29 members of the governing board to be patient advocates. (A list of those members is available on our website.)
The idea was to have their voices heard earlier on in the debate when they could have a bigger say in shaping the direction the research takes, to put the patient at the center of the research, and to increase trust in the process.
But while few would argue that patients and the public don’t deserve a place at the table there are many questions about how big a role they should play, and how they should be chosen.
To try and answer some of those questions a two-day working group meeting was held in Washington DC earlier this year. Hosted by the Hastings Center, a bioethics research institute, the meeting brought together 20 representatives from the FDA, patient advocacy groups, industry and health policy scholars. CIRM’s Senior VP of R&D Ellen Feigal and board member Duane Roth were also part of the conversation.
There were a lot of issues to cover such as how to balance the need for more voices without creating a huge, unwieldy body; the need for those voices to be informed and able to add something to the discussion and not just defer to the scientific experts; the need to understand how representative a patient representative is and will they report back to their community; the need for scientists and industry to accept and appreciate the enhanced role of the public in the process.
While the workshop posed more questions than it provided answers the overall conclusion was that greater participation by the public in research was important. The attendees came up with a series of recommendations including encouraging the FDA to undertake a greater outreach to identify a broader range of stakeholders, to develop new mechanisms for public input, and to provide training to both scientists and the public on how to work together.
The workshop was an important step in the process. The next step is for Hastings to write a paper on the discussion and move the debate to a wider audience. That paper is expected to be available later this year.
Clearly there is a lot of work to be done to turn these ideas into reality, but the workshop showed the growing acceptance of the vital role of patients and the public in the scientific review process; that it is no longer enough just to give them a seat at the table, they also need to have a voice.