High-tech tools have long been a part of the clinical trial landscape. However, when the wrong tools are used (or not used properly), patient engagement might suffer.
Meerim Almazbek, senior solutions director of community planning and optimization and global team lead for Within3, spoke with Outsourcing-Pharma about the points in studies at which communication gaps and similar problems occur, and how intelligent use of the right tech tools can make a difference.
OSP: Could you talk about some of the ways in which engagement, at various levels, is challenging or disconnected in clinical trial settings?
MA: As trials increasingly operate on a global framework and trial sites are dispersed across continents, the level of engagement requires changes. From sponsors and CROs to physicians and patients, all stakeholders need to be engaged equally. In this type of engagement, variables such as various time zones, different protocol versions, and different regulations can all impact the communication within the trial.
If these variables are not correctly considered, and all participants aren’t communicating effectively, then engagement can drop off, mistakes are made, and ultimately, impacts patients and product efficacy.
OSP: What are some of the ways sites and sponsors use technology to help solve such issues—and do such solutions sometimes create new issues?
MA: As companies like Within3 made significant advancements in the clinical trial space, new problems arose. We now view technology like EDC (Electronic Data Capture), RTMS (Randomization Trial Management Systems), and IRT (Interactive Response Technology) as standard, but to implement these changes on such a wide level isn’t easy.
With our insights management platform, for instance, the widespread proliferation of DCTs (decentralized trials) throughout the last few years means that compliance is a major issue. For clients, our inbuilt compliance systems are capable of navigating regulation in a range of countries and are a massive advantage.
OSP: Similarly, how might new engagement technology miss the mark, or fail to deliver for staff/patients?
MA: Because of the pace of change over the last few years, it’s important to have patients and users in mind with each development. At Within3, we bring the users along the journey with us. For users that are new to this technology, this means proper adoption mechanisms, but it also needs a user-friendly system.
Design-led thinking lets the user know we developed the platform with them in mind. And when it’s not done, complicated features often get in the way and can alienate key demographics. That’s why our product is cloud-based, accessible from any device, and with no need to download an app.
OSP: Can you share in a nutshell how Within3 helps organizations streamline their virtual engagement and communication?
MA: Within3 has been in the life science industry for more than a decade. We started because we saw the existing model of multi-stakeholder engagement and communication was holding the pharmaceutical industry back, and we wanted to change it.
Our mission to improve the efficiency of the life science sector led us to develop a virtual engagement platform. This product provides over-time engagement which fits the busy schedules of decision-makers and simplifies global collaboration. But now, we’re tackling bigger challenges as well.
This year, we launched the first-ever Insights Management Platform. It combines three critical technologies to not just better connect Key Opinion Leaders, but also help select the best ones to talk to and discover better insights using AI-powered Natural Language Processing from what they say.
For us, the challenge to the life science industry isn’t just about communication, but it’s about the complete process of gathering insights, and actioning them bringing the most value and ROI.
OSP: How might a clinical organization best determine where engagement disconnects occur? Can you audit the digital infrastructure, talk directly with the people on the ground, check in with patients, a bit of a combo?
MA: The key to identifying disconnects in the engagement process is communication with those involved in the trial. Gathering early insights into the trial process from all stakeholders, including Sponsors, CROs, Principal investigators, researchers, and patients, can help you understand the process from their perspective. This, in turn, can help you troubleshoot.
For example, if these conversations reveal a problem in Phase I trials, a company can then process these and make the relevant adjustments for Phase II. If a patient is considering dropping out because their travel time to the trial site is too high, or there is low uptake because emails have been going into junk folders, then you can identify these problems and fix them.
OSP: What questions might you ask a trial team to determine which areas might be improved?
MA: Across most trials, we see some common issues that appear frequently. These impact patient recruitment, retention, communication, and more. To tackle these, trial teams should ask themselves:
- Are the current channels of communication working in your trial?
- What is your role in the trial?
- What are some barriers or obstacles to your day-to-day trial activity?
- How does the uptake in technology differ on location and what do you think is behind this?
By approaching these questions with a critical eye, trial teams can then begin to develop solutions to problems they may not have known were even present.
OSP: Could you please talk about some of the ways the rise of decentralized clinical trials has changed the way site personnel engage with patients and even each other?
MA: Due to the prominence of the fee-for-service model in the US and Europe, the patient has never really been at the heart of the system. Decentralized trials are changing this and making companies operate with a patient-focused mindset. COVID-19 revealed both that life science stakeholders prefer to be engaged in a hybrid model and that it gets better results. It showed us that virtual platforms aren’t markedly different, but instead, they enhance interactions that have traditionally been face to face.
Ultimately, DCTs engage the patient on their terms. It removes barriers with travel and data reporting and has opened the door for more accessible, simple, and reliable healthcare.
OSP: Related to the previous question, you mention how the rise of DCTs has impacted and continues to influence management culture—could you talk about what we’re seeing there, and how that might in turn impact engagement?
MA: The important thing to understand and implement with the rise of DCTs is advocacy for a new way of working and a strong strategic plan in place for change management. The best thing leadership teams can do is be flexible to change, listen and action the communication challenges employees and patients alike are voicing and avoid trickling fear into the rest of the organization when it comes to a new way of working in this digital era. When we have these teams who are open to change, and they instill positivity, it has a more effective impact on the rollout of technology, ultimately creating more value, buy-in, and long-term adoption for the users.
Within this, we’re seeing the best management teams approach change with an open mind. A lot of companies are now sticking to the current model of DCT, and the solution isn’t to resist it and to tie yourself to outdated processes but to move forward and embrace the change.