The Aperio Blog

Demystifying the Decentralized Clinical Trial

Part 3: Three Steps to Figure out if You Can Go Virtual With Your Clinical Trial    

Cari KniolaDirector, Corporate Strategy
June 21, 2021

In Part 2 of Demystifying Decentralized Trials, we discussed some of the risks and benefits that go along with trial decentralization. In this article, we’ll talk about three steps you can take to determine if you can go virtual with your clinical trial.

 Step 1. Begin with the Patient in Mind

One of the main goals for trial decentralization is putting the patient first, so it only makes sense that you would begin evaluating decentralization trial with the patient in mind. While considerations of patient safety drove the decentralization of Covid-19 vaccine trials, continued patient convenience and access is an important consideration for future trials. The burden of participation in traditional trials is substantial. Travel to and from site visits and associated issues such as the need to arrange childcare discourage many potential trial subjects from enrolling in clinical trials or fulfilling study obligations, which increases timelines and drives up trial costs. The substitution of telehealth or home visits for office visits and data collection through wearable and mobile devices can greatly reduce the burden of study participation and thus promote efficiency.

To ensure that study planning is patient-centric, evaluating the schedule of events to assess what trial activities can be pushed out to patient homes is critical.  If barriers to decentralization are identified, rigorously investigate ways to overcome those barriers.  For example, if an assessment has not been validated for remote use, determine what would be involved in arranging such validation. Weigh the costs of such steps against the potential savings in subject recruitment and retention based on reducing the burden of study participation. Similarly, evaluate incremental costs of home nursing visits and wearable devices against potential savings in recruitment and retention costs.

Step 2. Right-Size Your Trial

Think of planning your decentralized clinical trial as an exercise in “right-sizing.” Trial planning should start with the goal of key activities being performed at or near the patient’s home, either physically or through the mediation of technology.   During your planning process, consider not only what has been possible in past trials in your indication, but also the potential for innovations that enable further decentralization.  If making a study activity virtual is not an option, consider amending the frequency to balance obtaining the required data points against patient burden.  Remember, the majority of trials are hybrid, with a combination of on-site and virtual components.  While there may be pressure for ‘more is better’, sometimes it just won’t be possible to decentralize some tasks.  What is important is that the trial is planned taking the possibility of decentralization into account and making the best decisions for both the study and the patient.

Step 3. Get Real – Be Both Aggressive and Pragmatic

As in any clinical development program, the goal remains conducting a trial that will advance development of the IP to the next phase. If history cannot provide a model for your trial, be prepared to make history. You can provide the model for others. However, it is not necessary to make history in every aspect of the trial. Wherever possible, identify approaches that have proven themselves, whether in trials and practices in your indication or in other contexts. Focus on identifying and evaluating opportunities for decentralization, then balance technological, economic, and regulatory considerations.

Input from companies offering decentralization services and technologies for clinical studies is incredibly valuable, but it’s also important to obtain guidance from those outside the technology circle.  Choose advisers and service providers who recognize that the overriding goal is not trial decentralization for its own sake, but putting patients’ safety and convenience first and conducting a successful, efficient clinical trial that advances your clinical development program.

Cari Kniola

Director, Corporate Strategy

Cari’s role in Corporate Strategy includes oversight of marketing and proposals, and working with the C-Suite in developing and executing strategic corporate development and growth.

Cari has over 22 years of clinical research experience in both pharmaceutical and medical device studies. During her career she has served in various roles, including study coordinator, field based CRA, clinical trial manager and eight years in project management. Her operations experience included roles with sites, sponsors and CROs, and she understands the challenges that each face. For the last two years, Cari’s role has focused on the corporate side of clinical research, using her operations experience and business acumen to drive proposals, marketing and corporate strategies.

When not planning Aperio’s next move, Cari spends her free time strolling on the Lake Michigan shoreline, hiking in the Indiana Dunes and fulfilling her obsession with LEGOs.

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