Tag Archives: PCORI

Patient Engagement in Drug Development: Myth or Reality?

HR-researcher_1Is the patient voice adequately represented in the drug development process? The situation has improved but the patient community is not yet recognized as a co-equal in drug development or regulatory review according to Marc Boutin, executive vice president and chief operating officer at the National Health Council, a panelist at a BIO International Convention session on Wednesday. “We scare you,” declares Boutin who says there is an adversarial connection between patients, regulators and industry but the relationship has evolved over the last decade. Patient advocates have developed strategies to amplify their voice and demand access, providing the data and evidence to help transform healthcare delivery.

A section in the 2012 FDA Safety and Innovation Act fosters participation of patient representatives in appropriate FDA meetings with medical product sponsors and investigators, and a new transparent framework to communicate FDA benefit-risk approval decisions to the public. From the patient perspective, “benefit-risk decisions are value judgments, they are not science,” says Boutin. He acknowledges that FDASIA meetings are a critical step but sophisticated patient engagement is still lacking. In-depth interviews, focus groups, crowd sourcing and other strategies should be part of the equation, he adds. Getting the patient perspective in benefit-risk could change the discussion dramatically and improve healthcare delivery, Boutin says. Ensure that clinical trials are designed appropriately for people with chronic conditions, for example, to understand the benefit-risk for a subset of the population. Continue reading →

A Weekly Advocacy Message from Mary Woolley: Uncertainty calls out for advocacy

Dear Research Advocate:

Budget Uncertainty Deepens
The House Appropriations Committee has postponed this week’s scheduled consideration of the Labor-Health and Human Services (Labor-H) funding measure. A New York Times article indicated that the bill protects NIH funding; but, given how low the overall spending number is for Labor-H, “protected” is most likely interpreted as the NIH being cut less than other agencies, themselves highly valued. The distance between the Senate (passed) and House (estimated) Labor-H appropriations — in excess of 20% — sets the stage for another continuing resolution (CR). What actually does happen next is uncertain, which is why advocacy is essential.

The Devil’s in the Details
There are so many health priorities on the line in the not-yet-official House Labor-H bill. Perennial threats are back on the table, including wholly unjustifiable underfunding of CDC, the elimination of AHRQ and PCORI, a prohibition on funding for health economics research at NIH, and more micromanagement of the NIH as well. If any or all of these issues strikes a chord with you, let us help you write a letter to your representative asking them to represent your views in Congress. Email info@researchamerica.org — one of us will get right back to you. Continue reading →