Before the global pandemic hit full force, the industry was already moving toward significant change in the conduct of clinical research. Common recruitment and retention challenges in traditional clinical trials were not going to disappear, and these issues were then exacerbated by the closure of sites to non-emergency cases. As an industry, we’ve needed to act quickly to modify our approach and fortunately, the solution was in plain sight. Decentralized clinical trials (DCT) had already begun to gain momentum, and the pandemic has dramatically accelerated their adoption. Enabling patients to participate in clinic trials from home is both incredibly important to maintain patient safety and data quality in ongoing trials and critical for many new trials as we plan for a second wave of COVID-19.
Researcher Turned Patient
Early on, as COVID-19 was just becoming a topic of serious concern, I was taken to hospital late at night by ambulance, which was scary for me and my family. As I awoke on the COVID ward, I could hear staff members talking, and they were scared, too. They were worried about how to use personal protective equipment, the interpretation of conflicting guidance, and if they were putting their own families at risk by being at work.
Only suspected COVID patients were being admitted to the hospital and there were security guards in place at the entrance. It struck me what a strange tone that set in a place fundamentally dedicated to caring for patients. In subsequent discussions with members of Parexel’s Patient Advisory Council, I’ve heard about the anxiety many patients with existing conditions experience when they need to attend at a hospital for standard treatment or a trial visit, not knowing what they will face there.
Rapidly Growing Acceptance
If I was passionate about decentralized clinical trials (DCTs) before, my own experience taught me that the ability to treat patients in the home is critical to ensuring that many receive the care they need. As the pandemic has accelerated adoption of DCTs, we are encouraged by the positive reaction from both patients and sites. With the world waiting and hoping for COVID-19 vaccines and treatments, enhanced patient awareness of clinical research might be mitigating the stigma. In one inspiring story, a whole family in the UK is participating in a vaccine study because of their commitment to helping others. I believe this will have a profound positive impact for the industry.
We have also observed a rapid increase in regulatory acceptance over the last few months. Some regulators had been reticent about telemedicine and e-consent, for instance, but that changed as they prioritized patient safety amidst the pandemic. It is unclear whether DCT guidance will remain post-pandemic, but I remain hopeful that the experience will make them more amenable in the long term. There is also greater site acceptance of DCTs as they have worked in different ways to support study participants. I was chatting recently with an investigator who remarked that if she had known how easy it was to make such positive human connections via telemedicine, she would have used it long ago.
Sponsors, as well, are looking to DCTs both for COVID-19 relief and as a longer-term solution. Some are trying it for the first time, others that had conducted DCT pilots are quickly scaling up, and some are striving to implement DCT for every study.
The Question of Study Suitability
The question, then, is how can you determine if a study is right for a DCT transition? Here are a few ways we have helped sponsors adapt to the current environment in order to keep studies on track.
In an ideal world, DCT services would enable all trials to run as planned through the pandemic. However, due to complex tests and procedures and challenges around patient safety, for some telemedicine alone has been implemented for investigators to maintain oversight of patient health in lieu of on-site visits. For lots of other studies, direct-to-patient drug shipments have been deployed, with medication delivered by specialist courier to the home.
Home nursing has also been used for tasks such as blood draws, urinalysis, vital signs, spirometry and electrocardiograms, enabling patients to participate whilst minimizing the infection risk of hospital visits. Other elements of patient apps besides telemedicine have also been useful, for example for patient diaries and ePRO completion. And, though newer, sensors are also useful for certain measures normally taken in the hospital. Whether used alone or in different combinations, each trial has been assessed individually and the most suitable combination for each situation developed to manage challenges in various countries around the world as required.
As well as the DCT elements themselves, working with strong partners has also been key to ensuring that we can effectively deploy at scale, maintain data quality, ensure data privacy and have effective integrations to enable accurate data analysis. Consideration of study milestones has also been important to ensure that there is sufficient time remaining on each trial to deploy the necessary services. For example, if there are only a few weeks left on a study, transition to DCT may not be the best option.
Strategies and Priorities
Many of the sponsors we work with have multiple trials ongoing and have appreciated the support we’ve given with prioritization. At Parexel Biotech, we have addressed this by triaging every study, weighing different considerations to determine the studies of greatest need, factoring in other issues such as home nursing availability and financial considerations when relevant. We could then move to finalizing the strategy and swiftly deploying the solution.
Let me conclude with another essential observation. In your overall assessment, consider these tactical aspects, but more important, whether a transition to DCT is what patients actually want. We learned early on in our DCT journey that patients can often surprise us with their preferences. For some indications, patients may still prefer site visits where possible, others are too anxious to leave the home, and sometimes you have a split. Providing choice is at the heart of our patient centric approach. And now, as we look to the future, we are seeing a huge increase in demand for DCTs. For many sponsors, this is a way to protect themselves against a potential second wave of COVID-19 and others have seen the value in the approach based on experience and are keen to continue. For optimal results, proactively planning of DCTs is highly recommended, and Parexel Biotech provides a consultancy service involving a pipeline review to help identify ideal target studies and put the necessary steps in place for success. This approach also enables early patient involvement in planning, so that their needs are truly being met, which in turn positively impacts patient recruitment and retention, which is the ultimate goal for us all.
Teaming Up with Parexel Biotech
As part of a world-leading CRO, Parexel Biotech offers the essential services required to support biotech companies in developing their important new therapies. Our lean operational structure and flexible processes enable biotechs to take advantage of comprehensive regulatory, commercialization and operational expertise developed over years of experience with leading biopharma companies. Your goal is to save lives. Our goal is to make that easier.