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Comparative Clinical Effectiveness Research: Setting Priorities At The IOM

What would it be like to have most of healthcare’s key stakeholders in one room, and allow each of them to take turns at a podium in 3 minute intervals? It would be like the meeting I attended today at the Institute of Medicine.

The goal of this public forum was to allow all interested Americans to weigh in on prioritization rankings for comparative clinical effectiveness research (CCER). CCER, as you may recall from my recent blog post on the subject, is the government’s new initiative to try to establish “what works and what doesn’t” in medicine. Instead of answering the usual FDA question of “is this treatment safe and effective?” We will now be asking, “is this treatment more safe or more effective than the one(s) we already have?”

There are many different treatments we could study – but let’s face it, 1.1 billion isn’t a whole lot when you consider that some CCER studies (like the ALLHAT trial) cost upwards of 100 million a piece. So we have to think long and hard about where to channel our limited resources, and which treatments or practices we want to compare first.

The public forum attracted most of the usual suspects: professional societies, research organizations, industry stakeholders, health plans, and advocacy groups. But the imposed time limit forced them to really crystallize their views and agendas in a way I’d never seen before.

I “live-blogged” the event on Twitter today and if you’d like to see the detailed quotes from all the presenters, feel free to wade through the couple of hundred comments here.

For those of you more interested in the “big picture” I’ll summarize my take home points for you:

Almost everyone agreed that…

  1. The process for establishing research priorities should be transparent and inclusive of all opinions.
  2. More information is good, and that CCER is a valuable enterprise insofar as it provides greater insight into best practices for disease management.

Most agreed that…

  1. Preventive health research should be a priority – so that we can find out how to head off chronic disease earlier in life.
  2. CCER should be considered separately from cost effectiveness decisions.
  3. One size doesn’t fit all when it comes to patient needs and best disease treatments.
  4. Physicians should be included in the CCER research and clinical application of the findings.
  5. Research must include women and minorities.
  6. CCER should not just be about head-to-head drug studies, but about comparing care delivery models and studying approaches to patient behavior modification.
  7. CCER should build upon currently available data – and that all those who are collecting data should share it as much as possible.

Some agreed that…

  1. There is a lack of consistent methodology in conducting CCER.
  2. We need to be very careful in concluding cause and effects from CCER alone.

The best organized 3 minute presentations:

In my opinion, the industry folks had the best presentations, followed by a powerful and witty 3 minutes from the American Association for Dental Research. Who knew the dentists had such a great sense of humor? Here are the top 4 presentations:

#1. Teresa Lee, AdvaMed – best all around pitch. In three short minutes, Teresa persuasively argued for transparency in CCER priority-setting, presented her top disease research picks (including hospital acquired infections and chronic diseases like asthma, diabetes, and clinical depression), the importance of physicians and patients making shared decisions about care (rather than the government imposing it), and the need to distinguish CCER from cost effectiveness.

#2. Randy Burkholder, PhRMA – “Without physician input, the questions we pose via CCER will not be clinically relevant.”

#3. Ted Buckley, BIO – “What’s best for the average patient is not necessarily best for every specific patient.”

#4. Christopher Fox, American Association for Dental Research – he said that “his good oral hygiene made it possible for him to deliver his presentation today.”

Most innovative idea

Dr. Erick Turner of Oregon Health and Science University suggested that FDA trial data be used as the primary source of CCER-related data analysis rather than the published, peer-reviewed literature since journals engage in publication bias – they tend to publish positive studies only.

Most shocking moment

Merrill Goozner, from the Center for Science In The Public Interest, essentially told the public forum hosts that the event was a terrible idea. He suggested that industry stakeholders were inherently biased by profit motives and should therefore not be allowed to influence the IOM’s CCER priority list. The crowd squirmed in its seats. For me, Merrill’s suggestion was like saying that a plan to reform the auto industry should exclude car manufacturers because they have a profit motive. Sure profit is a part of it, but reform is just not going to happen without buy in and collaboration. As I’ve argued before – there’s no such thing as complete lack of bias on anyone’s part (patients, doctors, nurses, dentists, health plans, advocates, or industry). The best we can do is be transparent about our biases and include checks and balances along the way – such as inviting all of us biased folks to the table at once.

I’m glad that happened.

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2 Responses to “Comparative Clinical Effectiveness Research: Setting Priorities At The IOM”

  1. Alvaro says:

    Val, thank you for the excellent update. Ted Buckley's point is critical and often ignored.

  2. Alvaro says:

    Val, thank you for the excellent update. Ted Buckley's point is critical and often ignored.

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