Decentralized Trials: Opening New Opportunities in Clinical Research

COVID-19 has shifted the clinical trial industry towards decentralization. Many companies and investigators are realizing the benefits of implementing decentralized clinical trial approaches, as they can collect high-quality data more efficiently, and the approach is widening the ability for researchers to collect different types of data that could be more competitive than traditional data collection methodologies. In this interview, Rasmus Hogreffe, former Head of Virtual Trials at LEO Innovation Lab, and current VP of Decentralized Trial Innovation at Medable, and Morten Kirkegaard, Head of Clinical Operations and Co-founder at REDO-neurosystems, will discuss their experiences with decentralized trials.

Moe Alsumidaie: Why is it important to transition into decentralized trials now?

Rasmus Hogreffe: The decentralized trial approach is hugely advantageous, as it enables us to increase data quality in our electrophysiologic clinical trials. This approach is in line with real-world settings, as we are capturing patient data where they are in their environment, without the interruption to their lives or the added stress of coming to the clinic, which introduces factors of variability and induces a bias in our clinical observations.

In a traditional clinical trial, there is an average of 20 visits where the participants need to be transported to the site to collect a blood sample, take an ECG, and measure various vital signs. Imagine if we could do, all or some of this, from the participants’ homes, using clinically validated devices.

Everything has been put on pause with COVID-19, and we are carefully assessing how to manage chronically ill patients to ensure patient safety, due to their increased risk of infection from COVID. We must consider the risk of a pandemic going forward because when conducting a traditional clinical trial, this current situation is critical to both patients and the produced data.

MA: Will clinical trials become entirely decentralized in the future?

Morten Kirkegaard: My vision is to bring the choice back to the participant. Some participants see great value with face to face contact with health care professionals, whereas many participants don’t have the time to take part in clinical trials. I envision that 90-95% of all clinical trials will be in a hybrid design in the future, including a combination of virtual or decentralized visits, home visits, and site visits. This will enable us to collect better data while reducing subject burden.

MA: What impact will decentralization have on the clinical trials industry?

Rasmus: I predict that decentralized trials will create an explosion of new studies, as decentralized clinical trial technologies will expand access to many smaller biopharmaceutical companies and investigators who today are unable to afford to conduct research using the traditional method. Data shows that we could expect to see a threefold increase in the number of clinical trials over the next ten years. In parallel with this growth, we will also experience a deficit in health care professionals involved in clinical research.

Morten: In my case, I am the lead principal investigator at my institution, and we do not have the funding necessary to outsource clinical trials. We are now evaluating moving forward with wearable devices in a practical approach instead of the traditional method, and that will allow me to improve research conduct efficiency, as I don’t have to be with the patient during study visits physically. Since our decentralized trial design is entirely automated, all we need to do is consent the subject, ship the device to subjects with an app containing instructions on study procedures, and we can monitor all the data from a central position.

One major challenge we face is a lack of clarity from regulatory agencies; in Denmark, for instance, the regulatory agency does not act in an advisory role. The agency supplies guidelines that investigators have to adhere to but does not advise on one’s mistakes. It would be helpful to have a standardized template from regulatory agencies to streamline processes and procedures that are accepted by these agencies. Patients are now getting used to having their entire lives virtualized, and it is time for regulatory agencies to modernize the standardization of decentralized clinical trial conduct.

Rasmus: Exactly. Remember, we are all focusing on the same mission - We want to develop better treatments faster for patients suffering from a disease. The pandemic has encouraged the biopharmaceutical industry and regulatory agencies to rapidly and radically rethink the traditional drug development process. As the saying goes, hard times bring on the most significant innovations, including the way we think, design, and conduct clinical trials.

MA: What will happen to companies who don’t innovate and don’t move into decentralized trials?

Rasmus: The same thing that happened to Blockbuster; they didn’t innovate and went bankrupt from surging online demand gobbled up by Netflix. That is a clear example of a company that did not follow the market and missed out on digital transformation. We have also seen the destruction of many companies through the introduction of digitalization; Airbnb is disrupting the hotel industry, and Uber is shaking the taxi industry. The biopharmaceutical industry isn’t going to be any different and should use digital and technology, where it makes sense.

Specifically,thebiopharmaceutical industry needs to think about being more cost and time-efficient in R&D. There is a definite advantage to adopting the decentralized approach. Companies who stick to the traditional way of conducting clinical studies will not have the same access to the type of data collected by digital solutions. That data will be the competitive advantage that will get a medical product approved by regulatory agencies, as well as gain payer coverage adoption.

MA: How has COVID-19 shifted the clinical trials industry?

Morten: For us, the pandemic and its impact on patient fear, as well as government shutdowns, was not something that any of us were expecting. As a start-up biopharmaceutical enterprise, we are still in the developmental phase of our medical products, and our timelines are critical. Right as we were planning to launch our study, COVID hit, and that caused significant delays. The pandemic forced us to think about decentralization strategies when designing new clinical trials, and the opportunities decentralization opens for us. While the pandemic harmed us, our new strategy moving towards decentralization is a win, as we thought about collecting data that we believe will make us more competitive, all while protecting subjects and site staff from pandemic related infections.

Rasmus: From the COVID-19 pandemic, we have learned that we are agile. We can use digital tools to run decentralized clinical trials. Post-COVID, I do believe that we will see a significant shift in adopting the decentralized approach. The pandemic has moved the authorities, Sponsors, and healthcare professionals to think in a decentralized manner, and scepticism about the approach has been erased. That is a big plus for innovation in the industry. While it, unfortunately, took a virus to start this dialogue, it is known that every crisis creates opportunities for growth and adaptation.

Moe Alsumidaie, MBA, MSF, is a thought leader and expert in the application of business analytics toward clinical trials, and Editorial Advisory Board member for and regular contributor to Applied Clinical Trials.