…Because subject enrollment is the biggest challenge in meeting your clinical trial timeline. If this is a recurring problem across multiple trials within your organization, it’s time to assess your clinical marketing approach. Although there can be a variety of factors that lend to low enrollment, one issue tends to surface regularly… why would a patient want to participate in a study for which there is already a “proven” therapy available?

Clinical marketing is an excellent way to inform and prepare both investigators and patients about the aspects of a clinical study, and helps to reach untapped sources of patients. The FDA has strict guidelines regarding claims and the promotion of a product that has not received clearance… an important fact to remember. However, there are several ways to help your sites and investigators address the issue of similar therapies and “proven products”.

There are many ways to reach new and novel customer areas, and also build confidence with your investigators and their current population base. Here are a couple of basic ideas: First, consider a patient brochure. A simple pamphlet can explain the generalities of your therapy or treatment with illustrations. Including a brief exposure to what may be available as an alternative is a great idea. This makes the treatment tangible to the prospective patient, instead of just a thought process. Also, tools that help your physician explain the process to their patient can be invaluable. Finally, consider tools that remind the patient of any follow-up requirements. This is not only best for the patient, but ensures necessary endpoints are met.

Have you budgeted for clinical marketing in your study plan? Why not? Encouraging patient participation and investigator confidence will work to ease your clinical trial process.

When a sponsor chooses to outsource an entire trial to a single CRO, I often wonder what will happen if the CRO doesn’t live up to expectations.

If all the knowledge of the study resides in one external team, there’s little room for error. Maybe the sponsor will replace the CRO the next time around. That leaves little recourse for the current study and its immediate challenges.

I’m a big proponent of the alternative best-of-breed approach. Imagine cherry-picking a team of experts. If one party underperforms, replacements can be found without overhauling the rest of the team and sacrificing the study as a whole. It’s a strategy gaining popularity because it’s self-regulating. Autonomy and interdependence raise the performance bar for everyone involved.

Dyad is a consulting firm focused on all phases and aspects of clinical trials. Dyad is not a CRO although some of the services do overlap services offered by most CRO’s. We’re in “the business of clinical trials”, meaning we keep the business dimension in mind as we solve or improve the clinical process.

By adopting a client centric point of view, Dyad has a unique approach to improving clinical trial results through greater efficiency and improved time to submittal. For instance, consider our data management services.  The mechanics of applying technology in the handling of CRF’s or eCRF’s is secondary to the value of the analysis and the client/site management that happens throughout the data collection phase of the trial.