Over the past 18 months, the COVID pandemic has made its impact on the industry and clinical trials, transforming the concept of decentralized clinical trials (DCTs). While DCTs were a part of the industry prior to the pandemic, the need for remote options has accelerated acceptance of these types of trials. 
 
With a DCT, the trial is designed around the patient. It may include elements such as data being collected away from the trial site through wearables or sensors, or a video or home visit replacing a site visit. This dramatically decreases the time and commitment needed for the patient to participate in clinical research, ultimately allowing more people to participate due to a lower barrier to access. Prior to the pandemic DCT uptake was slow but over the past year and a half this type of trial has made significant headway, revolutionizing the industry. 
 
Parexel, a global clinical research organization, was heavily involved with DCTs before the pandemic and is currently working on more than 160 DCTs. Contract Pharma spoke with Rosamund Round, leader of Parexel’s Patient Innovation Center, about this clinical trial transformation, additional challenges, and advancements being made with DCTs.

Contract Pharma: How has the industry transformed over the last 18 months?

Rosamund Round: Following the success of remote operations throughout the COVID-19 pandemic, adoption of DCTs has occurred at an incredible rate and has been fundamental to maintaining patient safety, trial continuity and data quality throughout the pandemic. What had been viewed largely as an innovation just a short time ago is now mainstream and will continue long after the COVID pandemic ends.

Parexel now includes DCT in 80% of phase II/III and 100% of phase IV proposals. We see DCT as the centerpiece of a new operating model and how we can best support patients in or near their home to improve trial access and experiences. 

Members of our Parexel Patient Advisory Council tell us that for many, DCTs have reduced the burden of trial participation. Sites are comfortable using telemedicine, which has become standard practice to communicate effectively with patients. Regulators have also swiftly evolved to provide clear guidance on DCTs.

CP: What considerations have gone into making this transformation possible? 

RR: The pandemic forced the industry to innovate. Often slow to deviate from traditional approaches, COVID accelerated the adoption of DCTs. At Parexel, we swiftly triaged all ongoing trials and converted them to DCTs as needed. We then created a clear process for incorporating DCTs into new trials, leveraging the expertise of our Patient Innovation Center and our large network of SMEs across the organization. This structure, along with regulatory expertise, patient focus, and strong relationships with a highly curated core group of vendor partners, enabled us to scale quickly. Parexel has been involved with DCTs since the first trial of its kind in 2011, so we fortunately had a wealth of experience to draw upon. 

CP: What are the additional challenges with DCTs and how can they be overcome?

RR: Some of the main challenges with DCTs are: 

• Ensuring that decentralization is considered from the very beginning, so that the trial is set up for success from the outset. Early engagement with sponsors helps address this and facilitates building study strategies together and incorporating patient feedback to ensure we can meet their needs.
• Bridging gaps in availability of some DCT services, particularly in Asia. At Parexel, our Patient Innovation Center staff and APAC DCT Taskforce are making local connections to ensure that patients have the opportunity to participate remotely, just as in other parts of the world. 
• Continuing to innovate, despite the speed with which progress has already been made. In some cases, it could be advancements that we can adopt from other industries. Micro sampling, partnering with pharmacy networks, new technology – they are evolving quickly and to provide the optimal patient experience we need to assess and adapt efficiently. 

CP: In what areas do you see advancements with DCTs

RR: In addition to the areas addressed in the last question, technology solutions are becoming more refined and in line with experience. A vast array of sensors are becoming available and, though adoption is currently relatively low, this is an area that holds great promise in reducing patient burden.  

The pandemic has highlighted disparities in research access and placed a strong focus on diversity in clinical trials and research presenting new opportunities to educate the public about clinical trials and their role in the development of new medications and treatments. Through our Discussions on Diversity research, a combination of qualitative and quantitative data sourced from respondents around the world, we identified critical barriers to achieving diversity in clinical trials while offering specific solutions to help ensure more equitable access for Black, Latinx, Asian and Indigenous communities. Ensuring that trial populations mirror those who will take the medication, is an important focus for the industry.

We see greater interest in methods for improving clinical trial participation for patients from underrepresented communities. Sometimes the disparity is socioeconomic in which case we can improve access by provisioning devices or data plans to reduce the practical and financial burden. We have also heard from members of the transgender community that overnight hospital stays can raise concerns or issues with how they may be treated by staff or other patients. With the ability to participate from home, this could be alleviated. 

Finally, supporting participants in their neighborhood and not necessarily in their home is a major advancement. Some people do not feel comfortable having medical professionals in their house for a variety of reasons. As an industry, we need to continue to look for ways to increase patient options that further enhance their access and experiences. When deployed thoughtfully, in partnership with both patients and sites, the full potential of DCTs can truly be realized. If the past year is anything to go by, I can’t wait to see where we are this time in 2022.
 
Read More: CRO Industry Update: Digital modernization, decentralized trials and advanced therapies drive outsourcing.

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Rosamund Round leads Parexel’s Patient Innovation Center and is focused on improving research access and experiences for patients and caregivers. This includes leadership of decentralized clinical trials services, activities to improve diversity in clinical research, and creation of other tools and services that reduce practical, financial and geographical barriers to participation in clinical trials. She has more than 15 years of leadership experience in patient engagement and innovation roles.