Clinical studies rely heavily on technology all along the pipeline—study design, patient recruitment, data collection, and more. However, the research industry, tending to be more cautious than other fields in many ways, does not always rapidly and warmly embrace new and emerging technologies.
If trial teams can deal with trepidation and other obstacles standing in the way of technology adoption, they can yield several benefits throughout the process. Outsourcing-Pharma recently connected with Melissa Easy, vice president of R&D technology solutions with IQVIA, for an in-depth look at some of the obstacles to technology adoption.
OSP: Over the years, how has the clinical research industry dealt with technology? In your view, do professionals in the field tend to be slower than other industries to adopt, more on the leading edge, or at the same pace?
ME: The clinical research industry has been slower to adopt technology solutions than others, like banking, real estate, or retail. Even today, in many studies, reams of paper are used to manage informed consent forms (ICFs), patient questionnaires, and more.
In many ways, that slower pace was intentional and set for good reason: We’re developing experimental medicines, vaccines, and devices where patient safety is of utmost importance. The industry is highly regulated, so new technologies should be thoroughly vetted to ensure data integrity and regulatory compliance before they are deployed.
That said, the time is now for our industry to embrace the digital revolution and deploy purpose-built clinical technologies to deliver safer, smarter, more efficient, patient-friendly trials. Personally, I started my career in clinical technology in 2009 when I founded DrugDev (now an IQVIA company). We focused on site- and sponsor-facing technology to improve the sites’ clinical trial experience and facilitate smarter trial design, country and site feasibility, site activation, investigator site payments, and more.
While patient-centered technologies were beginning to hit the market, it wasn’t until the COVID-19 pandemic that the industry began more widely adopting tools to reach patients outside of a clinic setting.
Today we’re rapidly deploying a truly exciting array of patient engagement technology solutions, which are more complex as they deal with clinical data collection. These include electronic consent (eConsent), electronic Clinical Outcomes Assessments (eCOA), connected devices/wearables, telehealth platforms, and more. At IQVIA, we have deployed these tools on hundreds of studies – from the simple to the complex, local to global – and are measuring promising outcomes.
OSP: Could you talk about some of the motivating factors behind tech acceleration?
ME: Let’s start with the pharma companies who sponsor clinical trials, as they are the ultimate decision-makers driving technology adoption. Their key motivators for driving tech adoption are to:
- Improve data quality to support better and faster decision-making
- Improve patient recruitment by making trial participation easier
- Drive operational efficiency across a trial lifecycle
And, as sponsors are capturing more data than ever before, with the right tech solutions, they can gather high-quality data and information that deliver actionable insights to drive smarter decision-making throughout the trial and generate operational efficiencies from trial planning and startup to closeout.
Site staff and principal investigators are critical to this equation because when you can make clinical operations easier for sites, the trial will run more smoothly and efficiently. Firstly, sites care about their patients and engaging them in a meaningful way. Site teams want to make sure the tech deployed in a study won’t increase the burden on their patients’ lives.
Secondly, sites want tools that help them with their day-to-day jobs, making things simpler with seamless integrations rather than having to navigate numerous systems or logins to get the job done. Finally, site teams care about regulatory compliance, so they know if their site is audited, they’ll be ready to participate.
Last, but certainly not least, are patients. While patients aren’t deciding which tech products will be deployed in a trial, they are often the ones interfacing with those technologies and, hopefully, reaping the benefits they offer.
In a recent IQVIA-conducted survey of more than 6,400 consumers in the US and Western Europe, all respondents noted that they expect flexibility and minimal disruption to their daily lives as a condition of trial participation. For example, 68% of respondents expect a trial to include decentralized options like telehealth when possible, and more than 50% said they were comfortable using email and messaging to participate in the trial.
OSP: Could you talk about some of the obstacles you typically see in clinical technology adoption?
ME: Perhaps not an obstacle, but a common misconception that can derail adoption is that tech solutions can fix any challenge. In fact, technology alone isn’t going to deliver the holy grail of faster, smarter, and more patient-centric clinical trials. The answer always involves a combination of experts, process, and technology.
If you have a bad process, tech alone won’t address the issues. Instead, it may make a bad process more frustrating. If technology developers do not consider the end user’s workflows, needs and motivations when you’re creating the software or application, adoption will be slow. It is important that there is a balance between all three and that teams are set up for success with comprehensive training. It is also key to never assume a solution is totally intuitive and seamless without proper training.
When teams have bad experiences with a product because implementation wasn’t properly mapped out, it can certainly hinder future adoption. But, when done right, you pave the way for progress and meaningful results.
OSP: Easing patient burden is one potential benefit of trial tech. Could you please talk about the potential benefits of current and emerging study technology tools that can help make patient participation more convenient/less stressful?
ME: There are so many ways that clinical trials technology solutions are better-supporting patients in their study experiences today.
For example, IQVIA Complete Consent offers a feature-rich, multimedia electronic consent experience for patients. ICFs are learning tools, and the goal is to fully inform patients of the risks and benefits of trial participation, but the traditional paper ICF can be incredibly overwhelming, full of medical and legal language that can be challenging to comprehend, especially in an often stressful healthcare setting.
A multimedia consent experience can better appeal to learners of all types (e.g., visual, auditory, experiential) and can ensure that patients feel fully informed when they make their decision to enroll or not enroll or to continue in a study when the almost inevitable protocol amendments occur and everyone must be re-consented.
Additionally, wearables and eCOAs are key examples. Wearable devices can offer less invasive alternatives to gathering critical trial data in real-time. This not only reduces the number of times a patient has to visit a site for the investigative team to gather data, but it also drives efficiency across the study lifecycle because we’re gathering more continuous, clean, and immediately usable data to meet endpoints sooner.
Similarly, eCOAs are questionnaires or diaries that patients can complete outside of a clinic at their own convenience when the information is fresh in their mind, rather than having to drive to a research site to then answer questions about how they felt a week or 10 days prior which can be challenging and frustrating.
OSP: Then, could you tell us some of the ways in which technology can possibly add to patient burden?
ME: We, as an industry, are asking more of our patients than ever before. While some tech solutions, like a wearable device that collects activity or biometric data, could reduce the number of times a trial participant has to visit a research site, anytime someone picks up a new tool, there will be a learning curve. Trial participants need to learn how to use the device or tool and how to meet the protocol requirements, such as ensuring they are entering information or sending data at specified times.
Another important consideration sponsors should keep in mind when assessing the right tech solutions for their trials is how patients’ daily lives and physical conditions are impacted by their disease. Some diseases hinder patients’ mobility, sight, or other functions, making tool accessibility for all critical. Offering “bring your own device,” or “BYOD” options to allow patients to engage in the trial using their own devices has proven to be a successful approach as the participants already know and are comfortable with their own tablets, phones, or laptops.
OSP: Please talk a bit about the regulatory issues around the adoption and integration of technology—how can it help, and what are some of the important things to keep in mind?
ME: As more and more sponsors consider building their own, purchasing, or licensing technology products to run decentralized trials or enhance traditional site-based trials, both the tech products and the manner in which they are operated and configured should be carefully aligned with applicable laws. Those could include, but aren’t limited to, the requirements of the International Council for Harmonization Good Clinical Practice (GCP) guidelines, local privacy laws/regulations, and clinical trial regulations.
It’s critical that sponsors get this right because the stakes are high. For example, handling personal data of participants living within the member states of the European Union in a way that doesn’t meet the General Data Protection Regulation, or GDPR, standards could result in penalties ranging from warnings to fines, loss of reputation, and damage to business relationships. Failure to conduct the trial in accordance with GCP and/or clinical trial regulations could result in data produced that is not adequate to support new drug, vaccine, or device applications to regulatory authorities.
The good news is, the industry is much farther along in evolving our approaches to meet these complex global regulatory requirements than we were even two years ago. At IQVIA, we consider it important to bring our experience as both an industry-leading CRO and a technology solutions provider to the table as we work with sponsors to build and execute compliant plans to integrate technology into their trials so that they can focus on reaping the benefits that these tech solutions offer.
OSP: Could you please talk about some of the products and services companies like yours can provide to help ease the implementation and integration of tech?
ME: Even if you have the best product in the world, you can fall totally flat if you don’t know how to operationalize it. The breadth of IQVIA clinical technology products (e.g., IQVIA Complete Consent, IQVIA eCOA, Investigator Site Portal, eTMF, Clinical Trial Payments) has been deployed in hundreds of studies over the years. And, when it comes to decentralized clinical trials, IQVIA has more than 90 studies underway, across more than 40 countries and 30 therapeutic indications.
Aiming to set customers up for successful results, we take the learnings from every product deployment and every trial to further our expert knowledge and tested approaches. For example, our regulatory database helps sponsors navigate a complex ecosystem of laws and guidances at the global, regional, country, and local levels to ensure compliance and data privacy. Our experts assess sponsors’ protocols early in the planning process to determine which products and services could add the most value to their unique study.
IQVIA’s global network of Prime Sites is trained and resourced to quickly deploy our technology solutions, which gives sponsors electing to leverage those sites the confidence that they don’t have to overcome an adoption barrier.
Finally, recognizing that sponsors may want to work within their systems and processes, most of IQVIA’s clinical technology solutions are designed to be configurable and interoperable with a sponsor’s current technical ecosystem. We believe that flexibility and integrations are important so that sponsors can focus on choosing the right solutions for their protocol rather than worrying about whether they will work with their existing systems.
OSP: Is there anything you’d like to add?
ME: I think it’s important not to lose sight of the progress we’ve made on driving smart, effective innovation in clinical trials. The world is digitally enabled, and patients are living in this digital world as are the teams of clinical professionals carrying out clinical trials.
As our stakeholders increasingly open up to technology solutions that make their trial experience better, we, as an industry, can focus on delivering important medicines, vaccines, and devices to patients faster. Maintaining our momentum to evolve and improve the way clinical trials run using purpose-built clinical technology products will be critical as we look ahead.