By Anna Rose Welch, Director, Cell & Gene Collaborative
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When it comes to patient enrollment and retention, engagement is key. However, keeping a clinical trial moving forward smoothly and keeping patients happy is a daunting, but necessary task. Clinical Leader’s recruit experts provide some best practices that can be used to ensure prospective and enrolled patients and their caregivers remain informed and active participants in the clinical trial space.
AR Welch: What best practices should pharma be employing to effectively engage patients (and ensure they remain engaged) in the clinical space?
There are several strategies pharma can employ to effectively engage patients in clinical trials. A few key practices to consider include the following:
- Crowdsourcing of protocols: Conducted through face-to-face focus group meetings or online surveys, trial sponsors are able to obtain direct feedback from potential study subjects about overall study design and the requirements for participation. Incorporating this level of detail into the protocol design has the ability to positively affect enrollment and attrition rates, in turn closing the gap from clinical research to consumer market availability.
- Recognize that study volunteers are healthcare consumers: Volunteers have the same expectations anyone would have when it comes to selecting a service and/or product. Pharma needs to capitalize on the survey data from study participants when designing protocols and/or any support program. This data is powerful in understanding the motivations and barriers behind study participation.
- It’s also important for pharma to identify and work with all parties involved in a particular trial. People are social creatures by nature, and there are many influencers in an individual’s life. In the case of Alzheimer’s disease, late stage oncology, or a pediatric trial, the caregiver’s involvement is required. At this stage, it’s not just the study participant you have to evaluate, but also — and perhaps more importantly — the caregiver. Solutions need to focus on how to establish communication and maintain a relationship for all involved. — Dan McDonald, director, business development, DAC Patient Recruitment Services
In the post-enrollment context, it remains to be seen if true best practices have emerged yet in what is a relatively nascent patient engagement arena. There are many tactical practices that are just now gaining traction. For example, patient reminder and reimbursement platforms have emerged as standard engagement tools, but one could argue that there is not enough data yet to anoint these efforts as engagement best practices. However, sites will typically only deploy or support patient engagement tactics if the associated processes are not too burdensome to the site or patient. Sites also prefer to hold the patient relationship close to the vest, and therefore, should the sponsor choose to turn to supporting services to bolster engagement, these efforts should not break the intimate patient relationship the site has worked hard to establish. — Roger Smith, SVP, global clinical operations, Acurian
Anything pharma can do to promote transparency will be beneficial in engaging patients. Today, patients can take advantage of a number of patient advocacy and disease-specific websites, as well as numerous portals, such as clinicaltrials.gov, that identify potential clinical trials in a variety of therapeutic areas. However, these are inbound vehicles. Social media is the next frontier when it comes to reaching out to patients. In this context, we should always bear in mind there is the potential for patients on a study to communicate treatment effects or side effects, essentially unblinding a treatment and invalidating — at great expense — the results of a clinical study. Patients in general are getting smarter and increasingly utilizing resources such as the Internet. As a result, they can be aware of the various diagnostic criteria for diseases and effects of treatment and may easily surmise to which group they have been assigned. There is also the increased potential for “shopping” clinical trials or sites and thereby skewing results. — Marc Hoffman, MD, CMO, Theorem
Sponsors and government agencies should work together to increase awareness of clinical trial participation opportunities for highly prevalent and fast-track diseases. Spending on trial recruitment activities should be socially and economically weighted. This will ensure that trials for fast-track diseases and highly prevalent diseases that carry a heavy economic burden will be able to quickly increase patient awareness, motivation to learn, and response to a call-to-action. Additionally, effective patient and investigator site education at all points of contact throughout the engagement life cycle and through patient-centric media, including paper, mobile devices, and websites, can result in higher retention rates. — Kurt Mussina, VP and general manager, Frenova Renal Research
To read the first article in this “virtual” roundtable series, click here.