Disclosing clinical trial data: public or private, the pressure is on
For every healthcare company, public or private, the anticipation of clinical trial data represents an important, high-pressure milestone in its communications planning. For a public company, there is an obligation to disclose data within a reasonable timeframe. For a private company, while there isn’t an obligation to shareholders, there is pressure from private investors, the medical community, advocates, and even patients.
Finding the right balance between the “duty to disclose” vs. “pressure to disclose” conundrum is not easy. Handled correctly, these milestones are a great way to raise visibility within the investment, clinical and scientific communities. If done wrong, the consequences may be severe.
Navigating the pressure
Public companies need to plan around specific events that are critical or material within their product’s clinical trial pathway. This includes trial design, patient enrollment, interim analysis, study completion and journal publication that is peer-reviewed or a presentation at a medical conference. And, if a company’s financial well-being depends on one product, then even relatively routine development milestones can be considered “material” by the Street and require disclosure.
Public companies have strict disclosure guidelines they must adhere to. Mistakes can lead to a true crisis that may result in stock downgrades, shareholders selling off their holdings, and a blow to the company reputation. Some situations even lead to Securities and Exchange Commission or Department of Justice investigations. Public companies should follow General Disclosure Guidelines to help their communicators disclose information in a timely, appropriate manner to avoid scrutiny. Some of these are elegant in their simplicity: have a data disclosure protocol in place, establish appropriate timelines, and most importantly, maintain transparency.
Private companies, although not answerable to shareholders, still must be responsible in disclosing data results as they are closely watched by regulatory bodies, physicians, patients, and advocates. In planning how best to release data, all areas of the company — from clinical to medical affairs to marketing and communications — need to identify what is the best-case scenario for announcing data. Is it a medical meeting and if so, which one? Is it a publication and how best to choose that publication? Is timing a factor in getting results out? If so, is an open access publication better? These are all questions that need to be discussed, analyzed, and answered ahead of receiving results. By answering these questions, a good/bad scenario planning begins to take shape.
Scenario planning
While no one can predict exactly when a trial will close and data analysis is complete, it is important to identify which medical conferences will be the best platform to present data. The questions will be: Can you get abstracts submitted in time? Is a late-breaking abstract submission an option? Is a smaller conference with less prestige, but a good chance of acceptance of an oral or poster presentation, a better more efficient place to disclose data? These are all important factors to consider when scenario planning.
Choosing publications can depend on not only what is good for the company, but what the Primary Investigator desires. Traditional peer-reviewed journals with high journal impact factors, (average number of times articles published in a particular journal in the past two years have been cited) are most sought after. However, there are a number of downsides to these traditional methods, including high cost for a multi-page report and publication delay due to limited publication and space. Publication can sometimes take close to two years, harming the ability to get data into the hands of clinicians to make important treatment decisions.
Scenarios beyond the traditional
Today, researchers and companies have more options. While social media sites may not be the best and most credible platforms, open access (OA) journals may be. If visibility, cost, prestige and speed are the four main factors in making the “where to publish” decision, OA is a formidable contender. Importantly, credible OA journals are still peer-reviewed and are given impact factors. In fact, some OA Journals, including Genome Biology, Molecular System Biology, and Molecular Cancer all have high impact factors and, in some cases, may rival the traditional journals. Thus, speedy publication in top OA journals can satisfy a number of needs by both industry and the research community.
Finally, communicators at healthcare companies need to be ready for any scenario that may come their way. How do you communicate positive data and ensure that interpretation of that data is clear and does not infringe on a claim? What happens if the data is a game-changer for disease treatment? How will you work with the FDA while satisfying disclosure needs for both the company and its stakeholders? There is also the other side of the coin. If the data does not meet its endpoints and the trial fails, how do you communicate to all stakeholders in a way that is responsible to stakeholders, and compassionate to patients? Full communication planning that covers all scenarios is key to being successful in disclosing data no matter what the trial results bring.
As you navigate the clinical trial pathway for your product, it is critical to have partners who have been on all sides of data results, and understand the best way to communicate to your stakeholders to ensure balance, compliance and productive discussion. For more guidance on communicating your trial results and overall communications strategy, visit https://icrinc.com/sectors/healthcare/.
ICR Westwicke is the largest healthcare focused investor relations firm in the country. We provide customized investor relations programs and independent capital markets advice to small and mid-cap healthcare companies.
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