The clinical trials industry is under no illusion as to how difficult it is to recruit patients to studies and then to retain them throughout the trial. There are many perceived and real burdens patients bear when engaged in a clinical trial such as lost days from work for site visits, travel costs to get there and strain on patients and their caregivers to devote time and energy to participate.
Increasingly though, trial managers, CROs and sponsors are looking to reduce these burdens by being more patient-centric. By focusing on the patient experience, these burdens can be designed out of the study or, where that is not possible, be mitigated through technology and strategy.
Patient journey maps can be created through relatively few focused interviews with patients to ensure trial staff gather the most amount of data from the study population, explains senior management consultant Jeffrey S. Handen, Ph.D. The map requires staff to determine how patients regard their condition and how they define success, with endpoints translated into meaningful ways patients’ lives can change.
Additionally, maps will take into account what real-world implications trials impose on patients. Among others, burdens include how often patients are required to visit a trial site, whether it is easy to travel to the site, and how invasive the treatment is. Any assessment must also include what can be done to alleviate these burdens, including the use of digital tools and other technology-based solutions.
A patient-centric approach takes more than handing out one questionnaire. Alleviating some of the burdens patients face requires continuous consideration and dialogue throughout the trial, writes Nicki Norris, CEO at Symphony Clinical Research.
Patient-centricity should not just be an industry buzzword, she warns, but rather a process with clear actions that benefit patients. For example, in-home, alternate site or remote visits are effective means of engaging more patients and eliminating some of the stress of participating in trials.
These are increasingly important given that research, as it evolves to be more inclusive, will focus on patient populations that are old, frail or immobile. Catering to these vulnerable populations is vital.
Regarding patients in a different light can make the patient-centric approach easier. It is helpful for trial staff, during trial design, recruitment and operations, to think of patients as partners rather than subjects, says Dr. Andreas Koester, vice president and global head of Janssen Clinical Innovation.
He notes that while this is not a particularly novel philosophy or approach, it is an important guiding star. Patients want to be recognized; they want studies designed to suit their needs as employers, parents and spouses. Using technology, whether through virtual trials or tools for self-administering treatment medications, lighten the burdens patients face in clinical research. However, Koester writes that implementing technology requires a caveat: It should cater to patients’ preferences and provide a personal touch.
For instance, patients increasingly want access to their health data and lab results. Koester says a response to this is to share all that is shareable without compromising the study — and to do this as soon as and as regularly as possible.
There are very specific burdens certain patients face. When it comes to the burdens associated with comprehensive neuropsychological testing, such as patient fatigue from lengthy studies and rigorous data collection, director of digital neuroscience at Cambridge Cognition, Nathan Cashdollar, Ph.D., says virtual research can provide an alternative.
Benefits of this approach include more frequent but briefer patient assessments. This results in improved patient compliance and reduces their fatigue. Another obvious appeal of virtual research is the absence travel for patients and their caregivers. Also important is patients’ improved control of and access to their data and how it is being used for a more personalized treatment plan.
Having a “dress rehearsal” for clinical trials may seem unusual, but it’s effective. In fact, a clinical trial initiative has been underway in recent years doing just this, writes Megan Laker, customer engagement consultant at Eli Lilly. The clinical research teams meet with patients, study coordinators, nurses, and physicians to prepare for clinical trial protocol. Part of this approach is to encourage prospective patients to participate in trials by explaining the purposes and processes of the study.
It’s during these discussions that all involved, including patients, can offer their opinions on treatment doses, site visits and providing samples. Patients can explain their perceived burdens, which can be addressed to make the trial more patient-friendly. Changes implemented by Lilly include making medical packaging easier for patients to open, reducing the number of invasive procedures, and planning overnight hospital or hotel stays for long clinical trial visits for patients who travel long distances.
Before participating in a clinical trial, patients will have a vague idea some of the factors that could be perceived as burdens, such as absence from work, cost and time of travel, and accommodation for caregivers. However, many patients lack knowledge of what to expect, and that’s especially for those who have never have participated in a trial before.
Experts, therefore, need to be preemptively consulted about how to reduce patients’ burdens, says Rosamund Round, director of patient innovation at Parexel. Nurses are effective sources of information in this regard, especially those experienced at high-performing investigative sites. They will be able to answer important questions about the balance between study burdens and standard of care; how protocol can be changed to improve the patient experience; and the best information that can be shared with patients to make them feel more supported and empowered.
Round explains how a team of nurse specialists convinced trial managers to eliminate several planned patient questionnaires. They were too long and the nurses believed the patients would disengage with the material.
A successful trial requires more than recruiting patients: it requires patient retention. But when treatment and study protocol demands too much of patients, they will likely abandon the trial, warns Matthew McCarty, global head of patient engagement at outsourced clinical research provider, ICON.
This is particularly so when patients are required to perform tasks outside of their regular routine. Virtual trials are an effective means of overcoming some of the challenges. For instance, digital recruitment, remote consent and mobile data capture remove the need for study visits. Without the need to travel or time lost when on site, patients can more easily fit the study requirements into their daily routines.
However, even with virtual trials, which McCarty notes may not always be feasible or sufficient, patient care remains of paramount importance. A centralized investigator will be required to provide oversight and monitor safety plans. They will also be able to guide patients as to when they are better suited to contact their primary care physician (for health concerns) rather than pursue a direct-to-patient contact center (for data collection and study logistics, such as support with wearable devices or reimbursement).
The prevailing method in clinical research has been to consider researchers’ and clinicians’ perspectives rather than patients’ priorities and perceived burdens, says Susan Bartlett, professor of medicine at McGill University in Montreal. While a patient-centric approach is becoming increasingly the norm, many drug trials persist in disregarding patient-reported outcomes such as fatigue or gastrointestinal distress.
But these are the very issues that will plague patients and potentially cause them to drop out of trials. Bartlett conducted focus groups in the US, Canada and Australia for patients with inflammatory arthritis. These patients suffered from fatigue, diarrhea and gastrointestinal pain, citing the issues as persistent and disabling. Medical staff, however, considered these “nuisance side effects.”
Treatment seems of little help when patients feel incapacitated, which highlights just how important the patient perspective is.
Accurate measurement of patient burden requires a shift in thinking and practice. Rather than assess patient burden qualitatively, which is the current method, the team at Medidata argue that using data to determine quantitative values will provide greater insight. Some patient burdens, such as pain, anxiety, and harmful exposure, are not usually part of the protocol analysis into patients’ suffering.
Medidata uses a patient burden index, quantitative framework to measure patient burden for each procedure. So if a patient has to endure a procedure multiple times during the trial, researchers will measure the total PBI with relevant rankings and benchmark it against similar studies. By adding a quantitative element to the calculation, study designers will be able to understand the pain points of patients and how these impact the overall experience of a trial.
Where possible, removing the burdens faced by patients during clinical research is essential to ensure they have a positive experience. Of course, when burdens are an inevitable reality patients will bear, trial designers and managers should ensure there are support mechanisms in place to mitigate these stresses.
By putting patients first, recruitment and retention will improve leading to far greater chance of conducting a successful clinical trial.
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