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GfK Healthcare | November 2010 | |
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REMS: Involving Marketing Research Companies to Ensure Best Practices and Greater Efficiencies  By Rony Ben-David, Vice PresidentIf there is a call by the Food and Drug Administration (FDA) for a REMS for one of your products, who do you trust to help in the process? While some might say a consultancy firm alone could handle every aspect of your submission, this article explores how integrating a marketing research agency into the process can bring greater efficiencies and help ensure the research is done correctly. In today’s reality, the FDA has the authority to require the submission and implementation of a Risk Evaluation and Mitigation Strategy (REMS) if it determines one is necessary to ensure that the benefits of certain drugs and biologics outweigh their risks. Even generic drugs may require a REMS submission. For new products, the REMS plan and materials are required at the time of New Drug Application submission. A timetable for assessment of the REMS itself must be incorporated at intervals of 18 months, three years and in the seventh year after the strategy is approved, or at another frequency specified in the strategy. A REMS may be mandated for any or all of the following elements:
It has been just over a year since a 36-page draft guidance document was issued by the FDA outlining the rationale and approach on designing and implementing REMS programs. It covers:
REMS – From regulatory protocols to refinement of communications The overall breadth of services needed to support implementation of a REMS program extends beyond the scope of “pure play” marketing research companies and may include, but is not necessarily limited to, the following areas:
Where best to leverage your marketing research partners Refining medical communications. Marketing research companies focus on helping clients refine their products’ positioning, messaging, sales tactics, pricing and all other types of communications – expertise that is critical to your REMS submission. This is done via qualitative and quantitative methods, alone or combined. The ideal way to ensure your initial communications materials are working as intended is to collaborate with a marketing research partner who will apply proven marketing research tools and methodologies to this objective. Through qualitative research, we can speak with respondents to uncover underlying issues or elements that need more clarity. Skilled interviewers probe beyond simplistic statements like “that paragraph is confusing/unclear” to find out not only what is ambiguous, but also to determine what can be done to make it more clear. Experienced interviewers are adept at employing a variety of research techniques that can uncover latent objections to the material. For example, some respondents may be reluctant to object to elements of a communication for fear of appearing uninformed or even because they may be uncomfortable criticizing materials that others have worked hard to develop. Solid and time-tested interviewing techniques will help overcome these situations. Determining the effectiveness of medical communications materials. A primary focus of marketing research agencies is testing the effectiveness of communications as micro as specific messages and tactics, or as macro as marketing campaigns and corporate strategies. Therefore, because ensuring the effectiveness of your medical communications materials is a required REMS component, a marketing research agency is a perfect fit for this objective. Such assessments typically necessitate quantitative research and require sample sizes that are sufficient to yield statistically reliable results. The primary information objective of this research is to assess respondents’ awareness and understanding of specific elements of the communications materials. For example: Are patients aware of possible serious side effects of the drug? Are pharmacists familiar with proper dispensing protocols? Do physicians understand the risks associated with prescribing the drug? Where the application of sound research practices is fundamental It is imperative that the REMS assessment survey be designed and administered properly to control for any bias and thus be able to withstand any challenges. A pure play marketing research agency is the go-to resource for ensuring a virtually “bias-free zone.” Controlling for sampling bias. Data collection must ensure a random selection of participants in the universe, and that an appropriate representation of the universe is able to respond. Your marketing research partner can offer unrivaled access to the requisite respondents, whether they are physicians, pharmacists, patients or other key publics, which is critical in your REMS assessment research. The data collection method must also be carefully considered. For example, if conducting a REMS assessment among patients for a drug that treats a condition prevalent among a lower socio-economic demographic, online data collection alone might not be sufficient because it may preclude participation by anyone who cannot easily access the Internet. An Interactive Voice Response (IVR) method may be a better option, as it will allow patients to call into a toll-free number and respond via an automated phone system. [An alternate method, Computer-Assisted Telephone Interviews (CATI), whereby an interviewer asks questions and enters in the respondent’s answers, makes it difficult to attest that the tone or inflection of each interviewer is consistent enough from interview-to-interview to make certain no bias exists.] Another option incorporates both online and IVR administration. When using this multimodal approach, proper measures must be taken to guarantee that online and IVR interviews are consistent with each other. Randomization of response options needs to be handled in a way that ensures there is no order bias between the two different methods. This segues nicely into the next vital consideration in designing a REMS assessment. Controlling for questionnaire bias. Applying sound marketing research practices in designing a survey is essential. Here’s another case where marketing research agencies prevail. Each question must be carefully crafted to ensure that it is not leading in any way to possibly give the FDA reason for challenge. For example, when asking about potential serious side effects of a drug, the response options should include the drug’s actual side effects and other plausible side effects not associated with the drug. Here too, it is imperative that response options are properly randomized to avoid order bias. The order of the questions in the survey itself must also be considered to make certain not only that earlier questions don’t bias later questions, but also that they do not give away the “correct” answers to succeeding survey questions. Although not specifically required in REMS assessments, companies should also consider informing respondents of certain incorrect responses. Let’s say a pharmacist gives an incorrect answer to a question regarding the maximum number of doses of a drug to be taken within a 24-hour period. At the end of the survey, respondents can be informed of the error/correct response, thereby making certain accurate information on product usage is understood going forward. It also allows important information to be further disseminated, which may even positively impact the results of future REMS assessments. A logical choice for your REMS research When the FDA first mandated REMS, pharma/biotech companies understandably sought out general experts, which were the consultants, to help the companies design the first programs and ensure alignment with FDA guidelines. Consultancies quickly packaged all REMS elements, offering the convenience of “one-stop shopping.” But as REMS requirements are becoming more standard occurrences, the marketplace can now focus on more efficient approaches by using marketing research agencies to do what they do best – providing knowledgeable and proper research design and data collection in a cost-effective and accurate manner. Perhaps marketing research agencies should team up with consultancies, allowing clients to make one call and still get all the efficiencies of one-stop shopping.  Want to learn more on this topic? Please contact:  |