The past 16 months have forced pharmaceutical companies to adapt their clinical trials to new ways of living and working. Social distancing protocols spurred by the pandemic led to 76% of more than 200 clinical trial sponsors conducting most or all of their patient monitoring remotely. This is a major increase from the 18% of clinical trials in the previous year according to Florence Healthcare’s 2021 State of the Industry Report.
As the global pharmaceutical lead on Salesforce’s Healthcare and Life Sciences Industry Advisory team, I participated in a roundtable discussion with executives from a number of pharmaceutical and contract research organizations (CRO) on how to move forward with clinical trials. There was consensus among the group that the pandemic accelerated decentralized trial strategies. These new approaches, coupled with emerging digital technologies, give the industry an opportunity to shape the future of clinical trials and, most importantly, the clinical trial participation experience.
In order to support the widest range of clinical trials, organizations should look to flexible technology platforms that offer a spectrum of tools and capabilities.
New initiatives are reshaping how clinical trials are being conducted. There’s a focus on increasing access to a broader, more diverse patient population. But at the same time, there’s a lack of clarity around the best way to approach virtual, hybrid, or decentralized clinical trials. Craig Lipset, co-chair at the Decentralized Trials & Research Alliance, stressed the need to adapt. “Best practices for decentralized trials are evolving rapidly as adoption and experiences are increasing across therapeutic areas around the world. No one can stay current and informed within a bubble — now more than ever the field demands collaborations and connections to sustain proper growth.”
Given the ongoing evolution of clinical trials, here’s how decentralized trials will shape pharma’s future.
1. Decentralized trials are viable
While sponsors and CROs have been talking about decentralized trials for years, many have questioned if they’re workable. Is the technology there? Will patients take part? The pandemic forced the industry to adopt digital and virtual elements to curb disruption in trials. To meet patient needs, new digital features like online enrollment, electronic consent, and more made their way into the mix. These pivots proved the viability of remote options. Some companies are making further progress by digitizing site and data management.
Only when companies accommodate individual needs can they increase patient enrollment and keep patients engaged throughout the course of the trial.
No guidelines for designing a decentralized trial exist — so much depends on the type of therapy. For example, a trial for a topical dermatological therapy can incorporate virtual engagement more easily than a study for a cancer drug. In order to support the widest range of clinical trials, organizations should look to flexible technology platforms that offer a spectrum of tools and capabilities such as electronic consent, self-reporting of data, centralized investigator site, supply chain management, and others.
2. Clinical trials need to prioritize choice
We need to partner with and focus on patients’ needs throughout the clinical trial design and trial process. What could make participating in a clinical trial less burdensome?
Every patient has different needs. To meet these needs, pharma and CROs are partnering with patients earlier on during the trial design and conducting more patient focus groups. They’ve found a wide range of preferences through their interviews. Some want to go to a clinic, some want an at-home visit, and some never want anyone visiting their home and would rather go to a third destination. Only when companies accommodate individual needs can they increase patient enrollment and keep patients engaged throughout the course of the trial.
Those who report their study offers childcare are more likely to report that the study exceeds their expectations (40%) compared to those who report that none of the listed convenience-enhancing solutions are used.
According to a 2019 study by the Center for Information and Study on Clinical Research Participation (CISCRP), top convenience-enhancing solutions include participation experience surveys (29%), text messaging (21%), electronic informed consent (15%), and smartphone apps (15%). And since 2017, the inclusion of these convenience tools has expanded. Use of smartphone apps grew from 10% in 2017 to 15% in 2019. Other areas of growth include wearable devices (5% increase in use since 2017), concierge services such as travel arrangements (4% increase), and text messaging (3% increase). Convenience-enhancing solutions may positively impact how a study meets a volunteer’s overall expectations. For example, those who report their study offers childcare are more likely to report that the study exceeds their expectations (40%) compared to those who report that none of the listed convenience-enhancing solutions are used during their study (14%).
3. Solutions for decentralized clinical trials are evolving
One clear starting point is to bring together patients and partners in a co-creation session around a particular trial. You can then use those insights to draft a protocol for decentralizing aspects of the trial — such as site visits — and establish goals around the study. Also consider putting together a governance committee or an internal consultancy. It will bring together cross-functional leaders who can provide their expertise along with assessing successes and challenges throughout the study.
While there are still a lot of questions about decentralized trials, it’s clear a patient-first, hybrid approach will prevail.
While there are still a lot of questions about decentralized trials, it’s clear a patient-first, hybrid approach will prevail. Providing many options to cater to a range of study participants ensures the study captures the breadth of the patient population it seeks without being limited by a patient’s location. Organizations can then partner with patients to determine what tools or processes they need during the trial. Implementing a secure, flexible platform that can support a wide variety of studies, as well as individual patients’ needs, will be key to successful trials moving forward.