Clinical trials that stimulate widespread interest among key opinion leaders and clinical investigators can still fall with a dull thud in the marketplace. Global exposure at medical conventions and congresses is no guarantee that the product’s end-users will even recognise the brand name of the study drug, let alone now its clinical outcomes, warns a new report from US benchmarking specialists Best Practices, LLC.
Timing is crucial if pharmaceutical companies want to leverage their substantial investment in clinical trials to maximum effect in the marketplace, says the report, From Breakthrough to Blockbuster: Best Practices in Communicating Clinical Trial Results. Yet there is a danger of jumping in too soon with results that show a significant impact on the target disease.
With lead times for US FDA approval typically stretching to a year or longer, companies should beware of drawing attention to study outcomes too early, only to see awareness fade before the product reaches the market, the researchers note. “Worry about competitors stealing your thunder, but also worry about physicians forgetting what your trial is about,” said one executive interviewed for the report.
Companies should also be careful to segment the core physician audience for clinical trial results. The information needs of primary care physicians are shaped by their heavy patient load; hence they are more effectively served by sales representatives who can deliver soundbites and top-line data, the report notes. Specialists, on the other hand, tend to be data-driven and suspicious of marketing messages or media overload. They are better reached through key opinion leaders (KOLs) or medical liaison teams, who can build credibility through more detailed evaluation of outcomes.
Customised messages that recognise the varying information and timing needs of the managed care community can speed up formulary inclusion once a drug hits the market, the researchers add. Managed care executives are looking for insights such as detailed pricing data (including cost comparisons with existing treatments), the projected costs of drug monitoring or quality of life measurements.
At the very least, Best Practices recommends, health outcomes information should be ready at the time of launch. Ideally, though, companies should be aiming to help managed care organisations with formulary budget planning before a drug is launched. This is particularly important when the product is first in class and/or will have a dramatic impact on treatment standards.
Companies should beware of rushing in too early with trial results but, as far as planning communications strategies goes, the earlier the better. According to Gary Shaw, vice-president of research and advisory services for Best Practices, the most common barrier to effective communication of results is lack of co-ordination and planning. Companies should really start the planning process even before a clear picture emerges of the study outcomes, he said.
Some have found it productive to put together a core communications team at the preclinical stage, which then tracks progress throughout the development cycle. By the time the drug is in proof-of-concept trials, these teams are already talking about potential messaging. Moreover, Shaw pointed out, the more sophisticated companies have a better sense of shaping messages, rather than just “pumping out propaganda”. This calls for a “playbook kind of strategy”, with early brainstorming on the full set of messages that might be drawn from a particular trial, he commented.
The mounting pressure for full disclosure of clinical trial results can actually help pharmaceutical companies with their communications strategies, Shaw believes. While the audience for these results is becoming “much more suspicious and jaded”, tougher disclosure requirements increase the onus on companies to provide both the appearance and the reality of communicating objectively.
Best Practices’ researchers found a clear emphasis in communications planning on adherence to evidence-based medicine, Shaw said. Even the slightest distortion of study outcomes can trigger a “huge backlash”. It only takes a couple of KOLs “turning sour” on a new drug to jeopardise the whole timing and impact of a launch programme, he warned.