Research must be actionable, relevant, timely, translated and transparent in its funding sources.
"Improved transparency of clinical research is a natural part of the larger sea change, where the buyer side of healthcare expects and needs transparency of provider performance," says Kip Piper, senior counselor at Fleishman-Hillard and president of Health Results Group, a Washington, D.C. consultancy.
"In physician and hospital reporting, the focus is on the value and the performance of the responsible decision makers, not the dollars they are paid," Piper says. "[Drug manufacturers] are following the same sensible approach for clinical research. Users of clinical research need to know who the sponsors are, but ultimately we must keep our eyes on the value studies offer. We need more published clinical research, not less."
"While we would not necessarily discount the results of industry-sponsored studies, it is helpful to know whether there has been industry funding in order to assess any bias in the study design or reporting of results. It is also useful to know whether clinicians who participated in the creation of guidelines or consensus statements have financial interests in the products they are promoting," Morphew says.
Piper adds that research must be actionable, decision-relevant, timely, translated, as well as widely disseminated.
"Transparency should be the same. Simply put, information decision makers need to make decisions, including assessing the value and relevance of published studies," he says.
TRUST DRIVES TRANSPARENCY
Disclosures by pharmaceutical manufacturers may be fueled by growing litigation and a wary public, says Jake Wengroff, spokesman for Frost & Sullivan, a growth consulting firm based in Mountain View, Calif.
"Rising healthcare costs in a recession have left most consumers with the sensation that the drug companies have lost their commitment to improving patient outcomes," Wengroff says. "These new disclosures will give patients a deeper understanding of how drugs are developed, encouraging patients to ask their doctors if the prescribed medication is absolutely necessary."
Perceptions about compensation to physicians and influence in the medical community are clearly barriers to trust, says Lilly spokeswoman Angela Sekston.
"We absolutely believe that championing these 'transparency firsts' will help build trust," she says. "With [our] physician registry in particular, we will be opening up for public viewing a part of business that some have been highly skeptical of."
Managed care executives may require greater disclosure, deeper than what the pharmaceutical companies plan to release to the public, says Wengroff.
"A managed care program may find itself with a public relations nightmare if it is later disclosed that it negotiated higher rates for particular drugs that earlier were shown to be well funded with payments to doctors and researchers," he says.
Hopefully, "the ultimate goal will be the adoption of consistent guidelines and reporting practices by all pharmaceutical manufacturers, regardless of their specialization or segment," says Robert Taketomo, PharmD, MBA, president and CEO of Ventegra in Glendale, Calif.