The success of most pharmaceutical products and medical devices is in part based on the expertise of learned physicians in designing and conducting clinical trials, interpretation of data from these trials, and eventually in educating healthcare providers. Historically, these esteemed physicians are the most recognized names at the highest-ranked medical schools and affiliated teaching hospitals. More recently, a new trend has begun to emerge: the rise and expansion of private research centers that are quickly rivaling their traditional academic counterparts. This phenomenon is a consequence of two significant developments over the past few decades.
Since the 1980s, industry funding for biomedical research by pharmaceutical and medical device manufacturers has surpassed the investment by the federal government. PhRMA estimates that member companies in 2011 invested $50 billion in the discovery and development of drugs. This amount, even without counting the investment by medical device manufacturers, is significantly higher than the $31 billion spent by the National Institutes of Health.
A second development is an increase in media and legislative scrutiny of relationships between industry and physicians. Many media stories brought questionable interactions into the spotlight, and legislators at state and federal levels began to put rules in place to increase transparency and minimize perceived undue influence of industry on healthcare providers. As the industry developed guidelines for interactions with healthcare providers, academic institutions began implementing their own rules limiting interactions.
The dwindling federal research dollars and ever stricter institutional rules are beginning to drive some investigators to switch their affiliations to private health organizations or start their own research centers. Early indications are that the quality of research at these nontraditional research centers is likely to be as good as that performed at major medical centers. In fact, a 2012 article by researchers from Harvard Medical School reported that “academic and nonacademic sites are equally effective in their ability to identify and retain appropriate study participants.” If the current trends continue, we can expect more industry-funded clinical research to be conducted at these private research facilities.
Many of the physicians at these centers are already well-known in their respective therapeutic areas due to their prior research and publications. Their personal reputations may translate into their new centers’ prestige, as they continue their contributions through congress presentations and peer-reviewed publications. In time, younger researchers from these centers may indeed grow into future thought leaders, just as those from academic research centers have done historically.
Emergence of these potential new “centers of excellence” presents opportunities and challenges for the manufacturers and for communication agencies. As the nonacademic research centers are managed by investigators who have expertise and interest in working with industry in various capacities as investigators, advisors, and educators, they may be more open to collaboration than the experts at academic institutions. They will also continue to maintain high ethical standards to protect their own reputations among their peers. However, there may be a need for the industry to educate them regarding the latest guidelines issued by PhRMA or AdvaMed, and the constantly evolving regulations at the federal and state levels, since these centers may lack the compliance infrastructure of the major academic centers. As communicators who facilitate interactions among industry, researchers, practitioners, and patients, it behooves us to keep an eye on this trend to better serve our clients.
CONTINUE THE CONVERSATION:
Questions? Comments? You can contact the author directly at blog@ochww.com.
Please allow 24 hours for response.
