Clinical trials have been significantly affected by COVID-19. On one hand, there is a surge of activity related to treatment and vaccination options for this novel coronavirus, but on the other hand, existing clinical trials have been severely affected.
Short-term impacts have rendered CROs and sponsors needing to monitor data remotely in order to ensure patient safety and continued data analysis, whilst protocol amendments have been required to implement the necessary workarounds so that clinical trials could continue. Direct-to-patient (DTP) decentralized strategies have been an important part of the solution for ‘in-flight’ studies.
Regardless, we have still seen substantial recruitment delays and impact to the supply chain, with a significant number of studies being suspended. Over the coming months, sponsors and clinical research organisations (CROs) will focus on how they can safely re-start clinical trials. As we move beyond COVID-19 and ask patients to actively move back into their medical community, we need to put the patient back in the spotlight, and ensure that their experience is the best it can be, wherever they are located – cue data and technology solutions that can bridge a ‘virtual’ gap.
In this blog we discuss the patient-centric landscape and consider what the shift will be as the industry deals with the blows served by COVID-19.
Patient-centricity is an important concept in clinical trial design, capturing a sense of the burden of disease and the patient journey. This is a fundamental consideration when facing two big challenges in a clinical trial, patient recruitment and retention. Patient-centricity is no longer a nice-to-have, it is a critical element of protocol design. More notably though, COVID-19 has shone a spotlight on how slow we are to embrace technology in industry, despite the fact that progression is required in order to improve patient experience. It has taken a pandemic to shake things up enough for the industry to recognise the need for change. Simply put, embracing technology is our future.
Clinical trial design has evolved over time. Some readers may recall a time when all clinical trials used paper-based source data and case report forms. It is almost unthinkable to look back on a predominantly paper-based system now. Technology has become an essential need, as it transcends through many aspects of a trial, such as Electronic Patient Reported Outcome (ePRO) devices, eClinical Outcome Assessments (eCOA), and data analytics. These advancements not only make clinical trials run more efficiently (in most instances), but they also act to safeguard data integrity, alongside improved user experience.
Who is the user though? Quite simply, it is the patient. The person who needs the treatment. That’s the reason the industry exists. Perhaps we lose sight of this sometimes.
How COVID-19 put the patient back in to the spotlight.
One of the many things that COVID-19 has done is illustrate how important drug discovery is in order to protect the human race. Clinical trials usually make headline news when something goes wrong, but in this instance, everybody has been touched by the need for testing, treatment and prevention of this novel virus. We are all invested and waiting for answers.
Social distancing and isolation during COVID-19 have highlighted how vulnerable clinical trial patients can be and how committed they are to attend their protocol visits and complete trial assessments. Without each patient putting their time into these trials, the whole thing falls down. It has also highlighted how Life Science companies need to do more to make clinical trials accessible to the wider patient populations, especially when they are no longer able to move freely.
Where do we go from here?
In the short-term, regulatory authorities including the FDA and EMA have offered guidance on how to best manage clinical trials under these extraordinary circumstances, but beyond this is a deeper requirement to embrace direct-to-patient (DTP) approaches, together with virtual and hybrid clinical trial models.
As an example of patient-centricity opportunity, we can consider that historically, clinical trial data sharing has been held tightly in house, but there has been a shift to promote data sharing over recent years, since the International Committee of Medical Journal Editors (ICMJE) pushed for a greater degree of sharing. On an individual ‘researcher’ basis, it is understandable as to why data sharing is a difficult area to navigate, but patients are more motivated to engage in their treatment options than ever before, and significant engagement opportunities exist when patients can see that their data demonstrates real outcomes.
A Change for the better
Beyond this there are many opportunities to use progressive approaches and technologies in order to optimize a clinical trial, for example:
- Research nurse networks/concierge services that facilitate a DTP approach in a patient’s home setting.
- ePRO devices and wearables
- Integrated cloud-based data systems – analytics, signal detection and a risk-based quality management approach.
- Payment systems that decrease burden.
- Digitalised patient recruitment campaigns.
GDPR considerations and transparent collaboration with regulators is critical to ensure that overenthusiastic adoption of technology does not lead to a poorly designed/conducted trial. Understand the capabilities and limitations of each approach in order to provide justification for use and to build trust with the key stakeholders (including patients and regulatory bodies). With a well-considered, well-designed protocol, technological advances can offer significant benefit.
There is understandable concern horizontally across industries right now, that to promote one’s business capabilities off the back of COVID-19 is seen as exploitation for self-gain. It is an undeniably difficult area to navigate. Some companies are choosing to offer services to hospitals and health authorities at a discounted price, or even pro bono. Ultimately, this is an industry need; sponsors and CROs need to embrace technology for the future of life sciences. It is both unfortunate and regrettable that it has taken a pandemic to highlight this need.
One final thought, since the importance of a patient-centric approach has been recognised, the primary route to put the patient front-and-centre is to empower the sites. Site staff should be engaged, well-trained and fully able to make the clinical trial a positive experience for all involved.
Now is the time for purposeful and meaningful progress. Let’s put the patient back in the spotlight.