Currently, no one in particular is accountable for incorporating patient-centric approaches to clinical trials and there are a multitude of methods, technologies, and product-ized offerings all claiming to be the answer sponsor’s need to reach their patient-centered goals.
The truth? There is no one way to achieve patient-centricity.
Another truth: a clinical trial is only as patient-centric as designed–and all efforts must be balanced against the budget. So, what can sponsors do right now to ensure patient centricity is not just a goal but a compass which helps guide all efforts?
There are 5 critical areas where sponsors can make a significant impact on the burden of clinical trial participation for patients. And, that, at the end of the day, is true patient-centricity.
#1 Early Patient and Advocacy Interaction
Engaging with advocacy groups to better understand the patient population is a first step. But not all therapeutic areas have an advocacy group. While common for rare diseases, advocacy groups can’t be the only way sponsors gather information about patients and their challenges.
Focus groups made up of individuals from within the patient population and advocacy groups are a great way to not only gather general information but test potential protocol designs. Find out and understand early on the specific struggles that each patient population is tackling, and study execution becomes that much easier and more effective.
#2 Flexible Protocol Design
According to a national survey in 2017, nearly 20% of clinical trials that closed or terminated did so because they failed to enroll or retain enough patients. While there are several variables that contribute to these data, protocol design is a significant factor.
If a protocol is difficult, it can be hard to find patients willing to sacrifice their time and consistently make the effort to participate. Designing a protocol that balances the needs of the study with reasonable expectations for the patient is ideal but requires a willingness to be flexible about how the protocol is constructed.
Consider the schedule of assessments: How many touch points does an investigator need? How many really need to be face-to-face to effectively assess a patient’s condition versus what can be done with a home health care nurse or some technology-enabled communication with the investigator. Telemed visits, ePRO diaries, home health visits and wearables are all options that can and should be explored depending on the study and built into the study design at the onset.
Of course, all of this varies from therapeutic area to therapeutic area. A wound care study has completely different requirements than, say, an allergy study. But a willingness to get creative about protocol design can make it easier to enroll and retain more patients, increase the bandwidth of sites, and improve operational execution.
#3 Travel & Logistics Support
Participating in a clinical trial not only costs patients time and physical effort, but it usually requires money. Such a situation is problematic for study participants and sponsors alike. Stipends with reimbursements are critical advances sponsors made decades ago but still require patients to pay out of pocket for–and arrange–any transportation, flights, food, parking, hotel stays and more necessitated by the protocol. This can severely restrict the potential patient pool.
There are a range of solutions that could be implemented by sponsors. Reducing the number of site visits by optimizing protocol design with a home health visit component automatically reduces the logistical burden. But every clinical trial that includes even a single site visit could, at the most basic level, provide pre-paid cards to cover travel expenses.
At the other end of the spectrum, concierge service for clinical trial participation logistics is seeing a rise in popularity. Providing full-service travel logistics is often a must for studies involving incredibly rare disease patient populations but other studies could also benefit from such a service. As sponsors expand their patient-centric efforts, considering ways to centralize travel and logistics for all active clinical trials could yield unexpected improvements in recruitment and retention.
#4 Consistent Patient-Centered Communication & Education
Patient education must go deeper than disease state and communication can’t rest solely on sites. As clinical trials have gotten more complex and more disbursed, communication with patients has failed to evolve in lockstep.
Sponsors that can centralize and normalize the information that is being distributed to patients across a study will normalize the patient experience, as well, and create a more consistent single source of truth. Ideally, such an effort would include two-way communication. Rather than getting a site phone number, calling in, leaving a message and hearing back in 12-24 hours, a patient portal could give clinical trial participants the ability to leave a chat or text message, get appointment reminders, reschedule a visit and more–no matter where they’re located.
Additionally, providing simple context around the standard points of communications goes a long way to helping patients feel like active participants rather than test subjects. Instead of just stating how many vials of blood will be required, explain why they’re being drawn in the first place–what information are the investigators trying to gain by taking those samples.
#5 Patient Health Care Empowerment
A patient’s health care protocol doesn’t begin and end with the clinical trial. They are humans dealing with conditions that require care before, during, and after study participation. Bridging clinical data with routine patient data is a huge unmet need.
Take, for example, an oncology patient who is participating in a clinical trial in Texas but seeing an oncologist in Minnesota. Accessing personal clinical trial data could speed or simplify their ongoing treatment protocols, yet that data is often difficult to obtain. Making it easier for patients to have a complete overview of their information so they can manage their care going forward would be a huge leap forward for clinical trial patient centricity.
Patients also must often wait years to get the results of a clinical trial–and, even then, they need to search for it on clinicaltrails.gov themselves. In the same spirit as informed consent, sponsors can create a more empowered patient by creating and deploying a simple “trial outcomes” document that explains the success or failure of the drug, what that means for them, and thanking them for their participation.
Patient-Centered Goals and the Sponsor Burden
When you’re dealing with people’s wellbeing, failure is to be avoided at all costs which, understandably, drives the conservative approach to implementing new methods, processes and procedures within pharma clinical trials space. No one wants a redo.
With patients becoming harder and harder to recruit and retain, however, there comes a point when change is critical to survival. Familiar, standardized structures no longer deliver the speed and modicum of guaranteed “success” like they used to. If we really want to be patient centric as an industry, then we have to be willing to do the hard work and step outside of our comfort zone.
Innovations from simple to complex blue-sky have been piling up on the table for decades. Sponsors have “only” to reach out and select the ones that make the most sense for bringing their study and their patient population together in the best, most efficient way possible.