Incorporating Patient-Reported Data into the Pharma Sales Story

September 2010, Vol 1, No 4

Atlanta, GA—Offering practical advice about how and when to use patient-reported outcomes (PROs) to make supportable claims in the marketing of new drugs and products, a workshop directed mainly to new product developers at the International Society for Pharmacoeconomics and Outcomes Research meeting in Atlanta clarified some of the basic issues surrounding the use of this type of research instrument.

The workshop reviewed the labeling and approval histories of several products, including Advair (fluticasone propionate and salmeterol xinafoate; GlaxoSmith Kline) and the human growth hormone somatropin, to show how manufacturers make claims using PROs, as well as the different standards Germany, England, and the United States use to evaluate PROs. Attendees also heard the merits of a claim-centered approach to using PROs to support marketing claims.

A Useful By-Product

PROs are data gathered directly from patients as part of a clinical trial, usually in the form of a questionnaire. These are often the only instrument that measures patients’ feelings about, and overall satisfaction with, the therapy in a typical clinical trial. PROs provide valuable data for researchers and for marketing departments, sometimes serving as evidence to support claims that a drug was efficacious or superior to another product in the marketplace.

Warning that the US Food and Drug Administration (FDA) scrutinizes comparative claims carefully and is inclined to view them suspiciously, United BioSource Corporation (UBC) Senior Research Scientist Asha Hareendran, PhD, explained that all promotional claims “must be supported by substantial evidence or substantial clinical evidence,” and the evidence required for comparative claims, or claims of superiority, “would include adequate and well-controlled trials designed to establish superiority of one treatment over another.” This requirement shapes the way drug companies market their products, Dr Hareendran said, because if they want to make a comparative claim, they must use PROs from randomized controlled trials—a higher standard of evidence than is required for non-comparative claims. She suggested that drug developers can use less costly conjoint analysis studies to support non-comparative promotional claims.

Dr Hareendran showed several examples of patient satisfaction evidence included in product marketing materials for several inhaler products designed to treat chronic obstructive pulmonary disease and offered some guidance on choosing the appropriate PROs for promotional materials.

Begin at the End

“When you are aiming for a label ing claim, it’s not something that you can decide at the extremes,” Dr Hareendran said. “Most of my colleagues in the pharmaceutical industry would say, select the instrument based on the concept that you want to claim on, and then make sure all the properties on the instrument meet the requirements of the 2009 FDA guidelines.’”

Dr Hareendran’s colleague at UBC, William Lenderking, PhD, echoed her call for a strategic approach to supporting promotional claims. Dr Lenderking, senior research leader at UBC, outlined clear priorities for how drug companies should support an advertising claim with the appropriate PRO evidence: begin with a clear sense of the “claim” or “story” you want to tell.

“It’s just such a basic concept—you need to know where you are going,” Dr Lenderking said. “What do you want to see in the Wall Street Journal, or on the FDA’s label claim, or what are the conclusions you want in the NICE [National Institute for Health and Clinical Excellence] appraisal?” Think about that, he advised, and then “work backwards from there.”

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