Participant recruitment remains an ongoing barrier to the successful and timely management of clinical trials.
In recent years there has been a significant effort to streamline processes and utilize productive and cost-effective digital outreach techniques; it costs a lot of money each day a trial is extended due to recruitment goals not being met. It’s no wonder, then, why effective marketing techniques are increasingly deployed to ensure the successful recruitment of clinical trials.
But can marketing become too involved and have a perceived negative effect on the scientific integrity of clinical trials?
Madison Avenue advertising agencies are often contracted to develop corporate marketing strategies for pharmaceutical companies. These strategies often include product-launch activities, marketing tools and public relations campaigns. Because the planning of these activities takes place prior to a product launch, is it appropriate for the corporate marketing agency to be involved with the marketing of clinical trials? On the one hand, the agency likely has the market research to determine the best methods to reach the target demographic; on the other, there needs to be a distinct separation between marketing a product and marketing a clinical trial.
There are strict adherences that must be met when marketing a clinical trial. Materials and advertising for specific trials should be more about trial awareness than typical marketing material. In fact, the recruitment of subjects is the beginning of the informed-consent and subject-selection process, according to the FDA. Before any patient-facing materials about a specific clinical trial can be distributed, an independent review board must review the messaging for coerciveness, or wording that suggests a favorable outcome or other benefits not outlined in the informed-consent form.
Deemed unethical but not technically illegal is what is known in the industry as “seeding trials.” These are trials designed specifically for corporate marketing goals and containing little to no scientific purpose. In these situations, patients and the principal investigators are given exclusive free access to a medicine and the way to use it. What make these types of trials unethical are the undisclosed, hidden marketing objectives and the exploitation of study subjects for commercial purposes. In seeding trials, the principal investigators may be unintentionally providing a sponsor with more valuable information than the study subjects are receiving.
According to “Marketing and clinical trials: a case study,” a reference model was developed as a guide to ongoing assessments of the marketing capabilities of a clinical trial. The model defines the capabilities required for successful marketing of any clinical trial. It has four domains and 12 components and is illustrated here as a wheel. Although rooted primarily in marketing technique, the reference model can be applied to any recruitment campaign regardless if it is a small site-facilitated plan, a strategy developed by a CRO or PR firm, or one conceived by a large creative agency.
Marketing firms and medical researchers have two separate goals, and blending the two can be tricky. Medical research is altruistic, scientific and done to meet a medical need. Marketing is about profit and return on investment. The clinical trials industry can learn valuable lessons from the marketing sector, but in order to avoid any perception of deception, sponsors should clearly separate research contracts from marketing services for their products.
Ashley Tointon has more than 18 years of patient recruitment and project management experience supporting clinical trials and the pharmaceutical industry. Currently she provides recruitment expertise, strategy and leadership as Principal Consultant of Accelerate Clinical Enrollment LLC. Email comments and suggestions to firstname.lastname@example.org.
This article was reprinted from CWWeekly, a leading clinical research industry newsletter providing expanded analysis on breaking news, study leads, trial results and more. Subscribe »