Private stakeholders representing a variety of interests brought a common message to the Federal Coordinating Council for Comparative Effectiveness Research's first public meeting: we want more involvement.

That message was a recurring theme throughout the first "listening session" hosted by the council on April 14 to solicit stakeholder input on comparative effectiveness research and the council's activities.

The council was formed as part of the American Recovery and Reinvestment Act and will, among other duties, report to Congress by July 30 a plan on how the $1.1 billion set aside for comparative effectiveness research in ARRA will be spent (¹ Also see "Where’s The Comparative Effectiveness Money Going? Plan Is Due July 30" - Pink Sheet, 23 February, 2009., p. 5).

Right out of the gate, the first of more than 30 speakers selected to offer opinions to the council pushed for more involvement from outside of the federal government.

Hazel Moran, representing the patient advocacy group Mental Health America, recommended that the government "create a national citizens' advisory board to help HHS better understand the perspectives and values of the general public when designing and disseminating CER."

She added that there should be an "explicit channel for patients to advise HHS on CER. FDA's patient representative program is an excellent model for this kind of participation. They train patients to be effective advisors and then include them on advisory boards."

John Lewis, VP of public affairs at the Association of Clinical Research Organizations, followed with his take on the need for broader participation in shaping the direction of comparative effectiveness research.

"Because expertise on CER resides in both public and private entities, every effort should be made to encourage public/private collaboration in the design, conduct, analysis and reporting of CER. We believe such collaboration should extend to include research sponsors, patients, providers and other stakeholders," Lewis said. "We realize that the composition of this council was established by legislation and did not provide for the inclusion of industry representation. Nevertheless, we urge the council to seek the required expertise to carry out this research, whether in private, government or academic settings."

Pharmaceutical Research and Manufacturers of America Assistant VP of Policy Randy Burkholder also asked "that the coordinating council would consider approaches to governance that incorporate all stakeholders from the health care community. This broad stakeholder representation, combined with open and transparent procedures, will help insure that research is centered on the needs of patients," while at the same time preventing any one interest from dominating or wielding a disproportionate amount of influence over research.

The desire by stakeholders to have direct involvement rather than just offering comments at public forums ultimately will provide support for Senate Finance Committee Chairman Max Baucus, D-Mont., who has not yet abandoned his vision for a public-private partnership to guide comparative effectiveness research. Last year, Baucus, along with Senate Budget Committee Chairman Kent Conrad, D-N.D., introduced a bill that would create such a public-private entity. A similar bill is expected to be introduced this year (² Also see "Baucus to Proceed With Public/Private Comparative Effectiveness Vision" - Pink Sheet, 2 March, 2009., p. 3).

Following the meeting, Agency for Healthcare Research and Quality Administrator Carolyn Clancy noted the importance of stakeholder participation.

"Let me just say that at AHRQ, we have found involvement of all stakeholders to be essential and really a tremendous boon to the work that we do, and I am confident that the council will be exploring all opportunities for as much input and engagement as possible," she said.

To that end, the council is planning to convene two more listening sessions in May. The second one will be held in Washington, D.C., and the third will take the council on the road, but a location has not been determined. The input will be a part of the process to help set the comparative effectiveness research agenda.

Clancy, who led the listening session, likely will have the most influence, along with Office of Management and Budget Special Advisor Ezekiel Emanuel, over how the $1.1 billion in research funding allocations will be spent. AHRQ has direct control over $400 million of the ARRA funds for CER, and she is the lone agency head currently on the panel, although the legislation does state that the head of HHS will serve as the panel's chairman (³ Also see "AHRQ’s Clancy, OMB’s Emanuel Key Figures On Comparative Research Cmte." - Pink Sheet, 23 March, 2009., p. 26). However, the process to confirm current HHS Secretary-designate Kathleen Sebelius is ongoing.

Disparities Also Highlighted

Another area that received attention during the session was the need for comparative effectiveness research not to seek a "one-size-fits-all" answer to a question of what intervention works best when treating a given condition.

A few speakers reminded the council that research needs to step away from the strict patient selectivity employed in trials to determine safety and efficacy in FDA approval, which does not necessarily translate into real-world usage.

Myrl Weinberg, CEO of the National Health Council, noted that her organization "believes comparative effectiveness research must address the needs and life circumstances of individual patients. Guided by the principles of evidence-based medicine ... CER must integrate clinical expertise with the best evidence and individual patient's predicaments, rights, preferences, and support them making the very best health care decisions."

Another way that disparities could be addressed would be through suggestions raised by Amy Miller, public policy director for the Personalized Medicine Coalition.

"As you consider priorities for comparative effectiveness research, we urge you to incorporate personalized medicine concepts and technologies throughout the effort," Miller told the council.

She added that researchers should get a genetic sequence for every research participant participating in comparative drug research.

"Individual variation and drug metabolism and sensitivity for over 30 classes of therapeutics have been identified by researchers," Miller said. "Based on the groundbreaking mapping of the human genome, we can now indicate if a drug is going to work for an individual based on genotype in some cases."

A Chance To Address Conflict Of Interest

With many stakeholders looking for ways to get a seat at the head table to make sure their point of view is heard, Consumers Union Senior Health Policy Analyst Steven Findlay called on the council to use this opportunity to address conflict of interest.

"We think that the CER program created by ARRA presents a unique opportunity for HHS, NIH, AHRQ and other federal agencies to develop a strong and clear policy on conflict of interest in biomedical research and publishing," Findlay said. "We have been inching our way in recent years toward more transparency in disclosure of conflicts. We view this CER initiative as an important opportunity to make a leap in this area."

Findlay said one of the goals of comparative effectiveness research should be a push toward making it free of all conflicts of interest.

"As a start, it should strongly favor researchers and institutions that are devoted to doing this research in the public interest and who have no current conflicts," he said. "After all, the very reason the CER program was created is that so much industry-funded research fails to adequately answer the critical questions that can help doctors and patients make treatment decisions."

He acknowledged that this would take time and offered a suggestion on the first step that should be taken: "We urge you to require from the outset 100 percent disclosure and transparency of all conflicts from both researchers and institutions."

- Gregory Twachtman (g.twachtman@elsevier.com)

Stakeholders Want More Say In Federal Comparative Effectiveness Effort

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