The pressures on the pharmaceutical industry look different than they did 10 years ago. AI is constantly being introduced in new areas and there are endless outside factors pushing you to get information faster – without compromising compliance. In this shifting landscape, to remain compliant and also think a little bit differently about surveys to not miss out on key insights.
Opportunities for Change
Within Your Organization
For many years, pharma companies have been largely risk-averse when it comes to survey design. There was a great deal of emphasis placed on the possibility that a response could generate an adverse event which comes with strict compliance reporting and follow-up to ensure patient safety. The result was to not ask key questions that provide great information to help guide patient care (even if the probability of an adverse report being generated was low). It’s time to be bold enough to think bigger.
As the demand for more information faster continues to ramp up, pharmaceutical organizations face the need to be more risk tolerant as opposed to risk averse. This approach means that rather than avoiding asking a valuable question altogether because of a small chance of a non-compliant answer, there is a plan in place to deal with it if it does.
Working with your internal teams, such as compliance and legal, to understand their tolerance for risk versus avoid risk completely allows safeguards to be put in place to ensure you aren’t missing out on key insights. This is an area where a strong research partner should be able to support you to find the right solution.
In this era of AI speed and information demand it’s essential to think a bit differently about the traditional guidelines without breaking any rules. Figure out what you can do to stay comfortable while not missing out on highly valuable data that allows you to bring drugs to market faster and make faster, better decisions with richer information.
With Your Research Partners
Communication is key when working with your research partners. Rather than simply asking your partner for sample or to program your survey, take the time to share what the goal of this research is. Before any work is underway, have a solid kick-off meeting and share exactly how the data will be used. Even if your organization has developed a risk tolerant approach there will be times, such as if your data is being published, where different types of approaches might be recommended. If, on the other hand, the goal of your survey is to gather a quick piece of information in order to make the next fastest, smartest business decision, there might be more flexibility on the types of questions your team is comfortable including.
This doesn’t have to be a major commitment that slows down your research process. Book a 15-minute alignment call or develop a standardized template for work you do on a frequent basis that just provides the key bullets of the project goals. These small steps ensure your partner understands the business need and how to support you in achieving the best possible outcome.
What Stays the Same
Despite the shifting approach to risk tolerance and partner communication, the fundamentals of compliance for pharma surveys stay the same. Both your organization and any research partners you work with should have a firm grasp on these areas.
PII Restrictions
Understand where there may be risks for PII being revealed and implementing processes to prevent this. Many digital research tools designed for healthcare have tools built-in to protect PII from being accidentally revealed. Your research partner should also be well-versed in how to handle anything that gets through to ensure you remain compliant and your project isn’t compromised.
Adverse Events
An adverse event in market research is any unintended or harmful experience reported by a participant related to a product, treatment, or intervention, and both you and your research partner should be deeply familiar with how to handle them. Your company should develop and provide annual training that is mandatory for anyone who works on your research projects, including external partners. Your research partner should be able to advise on when and how to design your surveys to mitigate the risk associated with them.
Fair Market Value Incentives
It is critical that you and any research partners understand Fair Market Value (FMV) incentives to remain compliant. These standards are part of industry regulations that help prevent any conflicts of interest or unethical deals while ensuring participants are fairly compensated for the services provided.
The Sunshine Act
To remain compliant, all pharma surveys going to physicians and other applicable HCPs must have a Sunshine Act disclosure before the main survey. This ensures participants understand that any earnings from market research will be reported and keeps the relationship transparent and ethical.
Conclusion
The goal of compliance rules still holds true: protect patient information, get them help right away if experiencing an AE, and maintaining clear boundaries with HCPs. None of that should change.
What should change is how much fear of a very unlikely possible outcome limits your ability to capture the rich data and information that is absolutely necessary today to make smarter business decisions.
Working with your internal teams to establish guidelines and thresholds for risk tolerance where appropriate is the critical first step. From there, communicating these standards and the goals of your surveys with your research partner is essential. Together, you can move faster and help more patients get the treatments they need.
