Trials and Tribulations: A Lesson in Data Communications

A company has invested people, money, resources and time into the development of a new medicine to treat a disease. So what’s the best news for patients, healthcare professionals and the company? It’s usually good news out of a clinical trial – especially when it is a Phase 2 or 3 study.

But the data isn’t always viewed positively by all stakeholders.

While the news may be focused on the positive when data is released, investors may not react favorably. There are numerous reasons why they may not view clinically positive data as good news for the company’s investment in a drug. The price tag to acquire or develop a medicine may be too high compared to the magnitude of benefit seen in the study. They may disagree with the data analysis based on the trial design. The data may not have met statistical significance or may show adverse events leaving unanswered questions. In the end, the results fell below expectations and projections. And when positive data are interpreted as neutral or negative by analysts and investors, there will likely be a drop in company stock price. In turn, this may shift the focus away from the data and towards questions about the investigation medicine, study, data analysis or the company itself.

The range of conversation can be a roller coaster of emotions for patients, caregivers, advocates and health care professionals, who filled with hope and encouraged by the seemingly positive results, are left with more questions than answers and are unsure who to trust.

Clinical trials are complicated, expensive and lengthy. Companies do their best to juggle innovation, patient needs, physician needs, regional needs, regulatory needs and timeliness. But with so many balls in the air, it’s easy for changes along the way—such as in enrollment criteria or endpoints— or for changes in the therapeutic landscape to confound the results of an ongoing trial. Morally speaking, as long as the data look promising the trial should go on for all parties involved, especially those enrolled in the study, but it can make the results more nuanced to communicate. It is essential that a positive view of the results be balanced with nuances or issues communicated clearly and transparently to all stakeholders.

A recent data presentation made headlines – first good, then bad.

Last week, a data presentation of a high profile investigational medicine resulted in news headlines across top tier journals. The company was focused on showcasing the positive side of the study results and, despite skepticism from some third party advocates and key opinion leaders, initial coverage was overwhelmingly favorable, showcasing the promise of the drug – even noting that the companies reached out to regulators for a potential speedy approval process!

But the larger healthcare community was skeptical and wanted to see more data from additional studies before making conclusions. Other investigational medicines in this class had fared poorly in clinical trials. And when investors noted issues with the patient selection in the clinical trial design, then had further questions about the usefulness or validity of the endpoints used, the company’s stock took a nosedive.

Investors’ critical view of the information lead to a multi-billion dollar drop overnight. And the very same outlets reporting on the data— including CNBC, CBS News, Forbes, and The Wall Street Journal —published new, negative pieces focused on the dramatic drop in stock price. Despite the initial headlines looking great, the immediate reversal was, in the end, not positive news for the company. Or healthcare professionals. Or patients.

As healthcare communications, we cannot change the data.

But we can be prepared to communicate it properly and effectively to all audiences, balancing the news while transparently informing the public.

Think holistically about every stakeholder. Investors are a key audience for data announcements – and while public relations professionals don’t directly influence or have relationships with them like investor relations professionals, considering investors is a necessary element for successful data communications.

Don’t hide questionable data or information. It won’t go unnoticed, so make sure you are leading conversations rather than reacting to them.

Make sure you look at the presentation data. The presentation always has details not disclosed in the abstract.

Carefully evaluate all data, even when it looks positive. Pay attention to the trial design, poke holes in the conclusions, and when possible compare the data to what is out there either competitively or historically. While it is not necessary to disclose details unrelated to the announcement being made, it’s important to understand the information inside and out to be prepared for any situation that could arise.

Be proactive in addressing any issues, both in materials and through preparing spokespeople. Clearly outline the issues along with the next steps the company plans on taking.

Companies balancing the needs of all stakeholders are sometimes in a difficult position when it comes to drug development and communications. I believe that approaching data communications with a complete understanding of each stakeholder and the desire to be transparent can not only help balance the news, but establish trust and credibility with those people who really matter the most – the patients.

This article was originally published on LinkedIn by Vanita Gupta, PhD, MBA, Medical Director.

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