This is part 1 of a 2 part series on patient centricity in clinical trials. You can read part 2 here.
Enrollment is the lifeblood of a clinical trial and is yet one of the most problematic issues. This blog explores the reasons why your patients may not enrolling and how they can be addressed.
Background
Most studies are initiated by a sponsor seeking out a clinical research organization (CRO) to handle recruitment. The CRO contacts potential study sites to ask if they may have patients who will qualify to be research subjects in the clinical trial. After that, there is sometimes little structured recruitment.
Typically, the CRO will reach out sites and ask them if they are treating patients who might qualify. In some cases, well-known or prestigious research sites (such as highly ranked university hospitals) may have qualifying patients. The sponsor would hope to get the more prestigious research sites on-board with the study. While they might have some patients who will qualify for the study, this recruitment model is not necessarily the best or only way to reach potential patients.
1. Define a recruitment strategy
Sponsor clinical trial departments and clinicians routinely see marketing as a four letter word. However, once clinical trial recruitment fails, sites often request Sponsors for money for ad-hoc marketing advertisements. These advertisement plans are neither consistent nor necessarily effective. It is important that companies have a cohesive and consistent marketing plan that work together and produce consistent and planned efforts.
2. Identify patients
Patients and caregivers routinely join patient support or advocacy groups to get information about their disease. These groups maintain a network of people with the disease state and help them stay informed and supported. Patient groups can help connect sponsors narrow down their recruitment efforts to patients with specific disease states. While direct patient outreach is allowed and benefits patients when done correctly, inappropriate methods can expose companies to significant liabilities (as seen here and here).
3. Maintain patient trust through the secure maintenance of information
For companies to begin engaging with patients, they must be prepared to maintain the security of patient information. Aside from the legal repercussions of improper disclosure of private health information, drug researchers are vying for patient trust. A patient may be reluctant to engage with organizations if they are not assured of the security of their information.
Distributed ledger technologies (DLTs) such as Blockchain, help facilitate the appropriate sharing of information. Through Blockchain, sensitive information is transparent to certain approved people but is secure and protected when distributed improperly. Because it is both transparent and secure, Blockchain ensures data integrity and privacy and can be used to help build transparency and trust with patients.
4. Spread awareness!
Spreading awareness of a clinical trial can take many forms:
Traditional Marketing
Sponsors or CROs can put ads in public places such as subways and billboards to spread awareness among a large and diverse group of people. Newspaper ads can also be used to connect with potential patients.
Digital Media
Depending on your target audience, social media ads such as Facebook or Instagram may also be useful.
In Person
Awareness campaigns can also target health care providers through their interactions with clinical research coordinators (CRCs). The CRC visiting the research sites can inform the physicians about other studies, or ask them to direct potentially eligible patients to them.
Considerations
As with anything in health care, regulatory concerns are paramount. Drug researchers must ensure that they have a solid understanding of what could go wrong when recruiting for a clinical trial via promotional activities. It is critical that the campaign for a clinical trial does not effectively advertise a drug for off-label (unapproved) uses. The FDA has levied multi-billion dollar fines on companies doing this type of promotion.
While it is understandable that many companies will be hesitant to pursue this type of recruitment strategy for fear of fines, there are ways to have FDA-compliant promotions for clinical trials.
This is part 1 of a 2 part series on patient centricity in clinical trials. You can read part 2 here.
If you have any other questions about how to find a marketer or want to review your current marketing practices, reach out to me on Twitter, LinkedIn, or send me a message here.
I also host a podcast called DarshanTalks, a show that discusses newsworthy FDA issues and how they apply to bringing a product to market – and keeping it there. From patient centricity in clinical trials to the government shutdown to CRISPR and bioethics to why big data is doomed to fail in healthcare, we’ve got quite the list of topics to review! Listen the podcast episode that inspired this post here or on Soundcloud.
