CRCs Share Perspectives, Advice on Trial Processes, DCT Strains
Screening, initial appointment logistics and first visits are the most frustrating trial processes for site staff, according to a new study on the burdens of critical processes and decentralized trial (DCT) methodologies that interviewed a select group of CRCs about their perspectives.
Trial technology platform provider ClinOne set out to measure the levels of frustration fundamental trial processes and DCT methodologies place on trial participants and sites, gathering insight from eight CRCs that together encompassed a broad range of therapeutic areas, including oncology, cardiology and rheumatology, at rural and urban sites of varying sizes.
The CRCs ranked trial processes and DCT approaches on a scale of one (least frustrating) to five (most frustrating) for site staff and participants and provided valuable insights on potential solutions.
For site staff, the patient screening process, rated a 3.00 on average, was the most frustrating of the five fundamental processes examined, followed by initial logistics (2.75), first patient visits (2.75), compensation (2.00) and labs (1.88), according to the study.
Elaborating on screening, the CRCs explained that many of their trials have numerous tests that must be completed within two to four weeks and require expedient scheduling. One CRC described the process as inflexible and challenging logistically for both sites and patients. For participants, screening ranked 2.63 on the frustration scale for the simple fact that they were raring to start the trial treatment; CRCs reported that patients felt frustrated by any process impediment during a trial.
On first visits, which were considered less frustrating for patients (2.38) than for site staff, the interviews revealed that lengthy, dense consent and prescreening documents were particularly aggravating for patients, as were first visits at which there were struggles to operate electronic patient-reported outcome (ePRO) devices or infusion nurses were unavailable.
To overcome this frustration, the CRCs suggested technologies could be used to provide participants with the ability to understand the protocol, investigational drug and study logistics in greater detail.
“Augmenting manual screening and scheduling technologies with visual aids, such as a study portal displaying relevant information, may help participants consume study activity information more easily,” ClinOne’s report reads.
In addition, the CRCs noted that information provided through very long consent documents is especially challenging for patients to digest and suggested employing supplementary learning resources “that give participants summarized, smaller amounts of information ahead of consenting so they [are] better prepared to absorb information once the formal consenting process begins.”
ClinOne found greater adoption of departments and schedulers specifically delegated with handling first visit activities and labs have been successful in addressing many historical site staff issues. Additionally, easy access to medical monitors, clinical research assistants and physicians on call are helpful, logistics-wise, for modern trials, the report reads.
The CRCs interviewed indicated the most frustrating components for patients are labs, diaries/ePROs/sensors, scheduling and first informed consent, with labs far and away the most aggravating, with a rating of 4.33.
In particular, the interviewees felt it especially important for coordinators to be on the ball when it comes to reminding patients of their lab appointments; frustration mounts when patients aren’t reminded of a lab and end up missing it, the paper notes. In addition, the CRCs cited difficulties in establishing efficiencies for labs due to their manual nature.
Diaries, ePROs and sensors were also a source of serious frustration for patients, rating 3.38 on the scale. The CRCs raised a number of considerations:
- Malfunctioning devices are a common occurrence;
- Patients sometimes forget to bring the device to their site visit;
- Some patients find it challenging to remain compliant with electronic devices;
- Some forget how to use the device; and
- Some participants do not have the dexterity to hold thin devices.
For first informed consent, which rated 2.75 on the patient stress scale, the CRCs suggested the process would be smoother with electronic consent (eConsent) applications but acknowledged this may not be the best approach for all patients, as many older participants were uncomfortable consenting electronically. Recent data from Memorial Sloan Kettering Cancer Center support the greater use of eConsent (CenterWatch Weekly, April 10).
Scheduling, which also scored 2.75 on the rating scale, was a notable pain point as well. For example, it can be difficult to book time slots with doctors for patients who require labs 90 minutes before their appointments. Combining therapies added to patient frustration in this area.
The CRCs recommended developing organizational templates capable of managing study expectations and logistics, citing difficulty in managing participant-specific activities, lab requirements and timing across multiple trials, especially when sites were forced to interpret the protocols themselves. Sponsors could provide resources that make the protocol clearer and more manageable for site staff and even patients, they suggested.
“Materials that explicitly and sufficiently detail activities at given time points, anchored to pertinent dates, would help reduce errors caused when interpreting unclear protocol descriptions,” the report said.
The CRCs also recommended sharing patient-friendly versions of organizational and informational materials to help communicate timelines, expectations and what would occur during lab visits. “CRCs saw the potential for educational material to minimize fatigue-driven disengagement they observed in participants overloaded with information.”
All in all, what should research professionals and sponsors take away from the findings of the study? Lead study author Allison Barnard, ClinOne’s product owner of site and patient adaptive experiences, tells CenterWatch Weekly that the results shed light on the most urgent site strains present in today’s clinical research landscape. While the rapid adoption of technology has introduced a number of new problems, technology can also help remedy them, she says.
“Based on our findings, the most pressing unmet needs for easing site burden are creating formal feedback mechanisms capturing site experience and feasibility observations and bootstrapping them into future study designs, and creating platforms that unify disparate technologies, ultimately decreasing the amount of technologies sites and patients are juggling,” Barnard said.
Access the report https://bit.ly/416BAZ4.
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