Clinical Researcher—June 2023 (Volume 37, Issue 3)
SITES & SPONSORS
Marc Crawford, MBA
Decentralized clinical trials (DCTs) are an effective means of reaching more diverse patient populations, overcoming geographic barriers to participation, and reducing day-to-day workload for trial investigators. However, DCTs also pose unique challenges because the critical elements of the trial, from administering treatment to recording and verifying data, no longer take place under the watchful eye of the investigator.
An article posted by the Association of Clinical Research Professionals notes, “The popularity of DCTs is making oversight of investigators more critical. As trial operations spread and become more remote, the role of the investigator as a center of gravity becomes increasingly vital.” It’s also increasingly vital, then, that the investigator at the center is correctly trained and prepared for all the specific elements of the DCT.
In the case of DCTs, investigator training takes place as investigators continue to join the trial, spreading training out over time rather than accomplishing it all at once, as in centralized studies. Today’s technology provides study sponsors the opportunity to hold in-person, virtual, or hybrid investigator meetings, depending on what works best for them. Regardless of the type of meeting, though, it’s important that all investigators receive clear and consistent training to ensure all sites adhere to the trial protocol.
Planning and Training for Success
The best DCT investigator meeting will have many similarities to the best centralized trial investigator meeting. Sponsors should begin by planning the meeting with the end in mind; that is, prioritize what they need investigators to thoroughly understand by the time the meeting ends and design the content around that. Consider the aspects of the DCT that will be new to investigators accustomed to centralized trials. Be proactive about challenges they may encounter and recommend courses of action. Once clear and carefully considered content has been established, add elements to the meeting that will engage the investigators in ways that not only keep them aware, but reinforce the information being presented.
Because there is a lot of important information being delivered in a text-heavy format, it’s helpful if the sponsor visually calls out the most critical details. For example, try to differentiate high-priority presentation slides from those of a lower priority. This could be through something as simple as placing an icon on the slide and telling investigators this is how they’ll know this is a slide to save or make notes on, if the technology allows, or to simply make notes about it, if not.
Since the clinical sites will rely on patients and caregivers for administration and data collection throughout the trial, their ability to clearly convey the elements of the study protocol to this group greatly impacts the trial’s potential for success. Trials with reduced clinic visits will rely on educational materials delivered to participants electronically. Sponsors should consider including materials in the investigator training that they can then share with the participants.
Is there a potential for a patient’s response to a treatment to be confused with another side effect or symptom? Could the wrong data be collected from a device if the settings are wrong? If there are mission-critical pieces of information that must be provided to the participants, sponsors must make sure to call these out during training and, if possible, provide investigators with background on how important they are up front. Consistent sharing of information in this way, from study sponsor to investigator to participant, helps maintain trial consistency. For investigators’ convenience, provide a digital toolkit alongside the meeting presentation that they can share with patients and caregivers later.
As with any meeting, investigator or otherwise, knowledge retention is increased by engaging participants. There are many tools to make sure the audience stays alert and engaged with the speakers and the content, including gamification, polling, and even the ability to just ask questions when they arise rather than waiting until the end. More than just “stay awake” tools, these can be effective at gathering information that can be used both in real time and in post-meeting assessment, as well as providing the trial sponsor with the ability to conduct dynamic follow up based on individual site needs.
Polling conducted at the beginning of the training, for example, can gather demographic data about the investigators taking part so presenters know whether they are working with a fairly novice crowd, a group of experienced researchers, or a mix. Polling at the end can determine how well the attendees learned the most important information—and do so before anyone leaves the room. If the results show a significant portion of the investigators are missing a key detail, presenters can redirect their focus to that topic before convening. By keeping investigators engaged, sponsors can gain motivated study sites, provide the necessary training, and uncover any gaps that need to be addressed for a lower risk, efficient clinical trial.
The greatest advantage of polling, however, isn’t simple engagement; the game-changer comes from crafting more significant polling questions. For investigator meetings, case-based scenarios that are relevant to the study provide more value to investigators than simple “do you know…” questions. For example, create a case with statistics around a patient. Then ask, “Would this patient be relevant to your study?” By doing so, sponsors can provide real-world perspectives on what types of patients to enroll and which wouldn’t be a fit. Make case-based questions complex and as realistic to the study as possible so decisions must be carefully considered before answering. In a DCT, investigators likely won’t have the experienced clinical staff of the onsite study center to rely on, so homing in on real scenarios that may occur can speed up their ability to make decisions during the study.
As important as it is to keep the investigators engaged, it’s also critical to gather actionable insights that will help make the meetings consistent—and better—over time. Since investigators are coming into the DCT at different times, sponsors will have the opportunity to present many investigator meetings. Through engagement and analytics tools, they should be gathering information as to not only who attended (the demographics mentioned earlier), but what types of questions were asked most frequently and about which pieces of content; what polling questions were answered incorrectly by the greatest percentage of participants; and what insights or suggestions might have been received through open-ended comments that would help make the next investigator meeting more impactful.
Partnering Up Wisely
When choosing a technology partner, sponsors should look beyond the moments they’ll actively be presenting and engaging with investigators during the meeting. Instead, look for a partner who can both engage in the moment and gather the insights needed for looking at a single meeting or a series of meetings related to the same study in order to make strategic changes. Sponsors should also ask for detailed post-meeting reporting that will guide them to specific people or sites who may need additional training to be successful. The technology and expertise to do this exists, so take advantage of it to provide better training that predicts and overcomes some of the challenges investigators might encounter in a DCT.
Most importantly, because decentralized trials are just that, study sponsors need to make sure there is significant and clear communication with the investigators and their sites, and that they do what they can to facilitate clear and accurate communication between sites and the participants. A well-planned and highly engaging investigator training is a critical first step.
Marc Crawford, MBA, is CEO of Array, a private company based in Denver, Colo., and focused on providing content engagement technology and services designed specifically for virtual, in-person, and hybrid life sciences events.