By Jennie Sheridan
In the spring of 2020, sponsors and sites were forced to rapidly implement elements of virtual trials in order to continue their studies while maintaining COVID-19 safety protocols. They quickly adopted operational tools and innovations such as wearables, mobile nursing visits, and remote data collection. Now, the industry is taking stock of the pros and cons of such virtual tactics to determine the best steps forward for patients and sponsors alike.
As a result, the industry seems to be moving toward implementation of a hybrid model across studies instead of choosing either a traditional, fully in-person model or a fully virtual model. A hybrid approach allows sponsors to balance the operational aspects of a trial with thoughtful trial design that best meets the needs of patients. Sponsors can consider design factors such as the number of in-person treatment visits that may be needed, how much data collection can be fully automated, or what testing can be remote or digital so their trial can meet planned enrollment. By assessing these factors, their impact on patients, and the complexity of the protocol, sponsors can also design protocols to fit patient needs.
Hybrid trial recommendations that help reduce patient burden
Engaging with patients early in the study design process allows sponsors to better understand what would make a trial work best for patients, their caregivers, and their families. To get to that point, patient groups can help sponsors to identify barriers up front such as travel distance, length of study visits, and financial costs to patients to determine what aspects of the trial could be better designed to reduce patient burden.
For example, patients with rare or serious illnesses are often highly motivated to participate in trials, but they may have barriers to enrollment or continued study participation, so taking the time before a study to identify such barriers and create an appealing study design can help to ensure patient participation.
Now, let’s work through a handful of recommendations:
- Having nurses and phlebotomists conduct mobile visits at a patient’s home, or virtual visits, not only reduces patient travel and expenses but may alleviate other obstacles like childcare or lost wages.
- Planning study visits to include remote or virtual visits especially as the trial progresses can provide some relief for patients. This allows for relationships to develop between patients, caregivers, and study staff early on, and as comfort levels grow, visits can be conducted virtually or remotely as feasible, which in turn increases patient retention.
- Reducing required travel to sites allows for clinical trials to be more accessible to broader patient populations, which may facilitate the inclusion of traditionally underrepresented populations.
- Allowing patients to choose between remote or in-office visits when possible gives patients more control in their care.
Communication tools such as study websites or electronic reminders for completion of study assessments (e.g., electronic patient-reported outcomes or virtual visits) help ensure patients are not only completing their study assessments per protocol, but also engaging with the study and furthering the trial connection. At study completion, sponsors can simply thank patients for participating but may also consider disseminating the study results to all participants, which is a frequent gap for patients who complete a clinical trial. Understanding the patient experience before, during, and after trials can help to inform future trial designs.
Technology such as wearables allows for the collection of data in more natural settings (i.e., real-world data) and across a longer time frame than a traditional in-office assessment. This type of data collection provides a more comprehensive and longitudinal view of certain data points and may also provide access to data that may not have been easily collectable. For example, a study can collect daily sleep data using actigraphy, an endpoint that is related to patient quality of life and especially meaningful to patients.
Navigating the expected challenges
To effectively put patients at the center of trial design, some challenges remain to be addressed. No single technology or platform is used uniformly across all studies and sponsors, so study staff need time both to learn new technologies and to find time to use them, which can be challenging when sites are simultaneously running multiple studies. Integration of multiple vendors, such as home health nurses, requires additional oversight on behalf of the site to ensure proper execution of the protocol and seamless communication regarding care management. Training on new technology and hybrid tools will be key in successfully transitioning to a hybrid model, and as sites become more proficient with these tools, they can expand their capabilities to conduct more trials.
Additionally, study protocols have grown increasingly complicated over the last decade. As studies employ fewer in-person patient visits and collect more data remotely, sponsors may need to simplify protocols to collect the primary data needed to assess safety and/or efficacy and put training plans in place for data collection tools. Sponsors will need to focus on key endpoints and shift away from “nice to have” or exploratory data when designing protocols.
Tools and technologies that reduce the number of in-person study visits or assessments are thought to be a means to reduce patient burden, but there is still a need for in-person care, especially among patients with rare or more serious health conditions. Not all patient populations benefit from fewer in-person visits, so finding an appropriate balance is key to trial success. Trials that require more specialized treatment or testing may, for example, involve more in-person visits but allow for the use of a wearable wrist device to capture a patient’s activity and movement.
Some sponsors may worry that decreased in-person touchpoints between patients and study staff will negatively impact retention. The personal element, as previously mentioned, is important to many patients, so sponsors should consider a proper balance that keeps patients connected without feeling overburdened. Having a plan for ongoing patient communication and outreach should be top of mind for sponsors and sites alike.
Hybrid design brings value to all stakeholders
Reducing patient burden is expected to increase enrollment and retention, resulting in lower overall study costs. More importantly, designing studies to reach populations that are less involved in research may provide results that are more representative of all the patients who may eventually use the drug being studied. As a result, patients will have a more active role in their care and a better understanding of their condition.
But there is no cookie-cutter approach for successfully conducting clinical trials. All trials are unique, spanning study phases and a vast array of therapeutic areas. While it’s imperative to continue pushing these innovations and revised processes forward, we need thoughtful and well-designed trials to collect quality data and reduce patient burden, helping the industry continue toward increased patient centricity in clinical research.
Jennie Sheridan is a consultant with Halloran Consulting Group. She has more than 10 years of experience in clinical study management, clinical monitoring, and project management. She provides project management and clinical operations support within Halloran’s biotechnology and pharmaceutical practice areas, including leadership and conduct of clinical trials, CRO and vendor selection and management, and development of operational tools to enable efficient clinical trials.