From Clinical Strategy to Development: Navigating COVID-19 to Support the Next Generation of Patient-Focused Treatments
- The COVID-19 pandemic has imperiled clinical trials in many ways, one of which is disrupting a patient’s ability to have traditional in-person study visits, thereby potentially jeopardizing patient care and safety and the long-term viability of the study.
- Decentralized clinical trials (DCTs) leverage patient-centered technology and innovations to rethink and sustain critical research while boosting patient engagement, recruitment and retention, expediting time to market.
- Parexel Biotech is a pioneer in partnering with the industry to deliver decentralized trials and has the experience and data to guide emerging companies through the evolving pandemic from pre-IND to Post-Approval.
We interviewed Graciela Rácaro, Global Head of Operations at Parexel Biotech, an industry leader that specializes in making the clinical development journey more effortless for small and emerging biotech companies and keeping patient engagement central to delivery. Ms. Rácaro has more than 20 years of experience in the pharmaceutical and CRO industries and a highly successful track record of executing complex initiatives and leading global teams.
The COVID-19 pandemic has upended nearly every industry across the globe, including biopharma. What has been the most significant impact to the patient experience in a clinical trial?
The COVID-19 pandemic has certainly disrupted—or has had the potential to disrupt—business and project operations in a host of ways.
One of the major issues is site access. Despite more sites now being open, patients may have limited ability and inclination to visit in person and receive their treatments. This may put patients at risk of treatment interruption, and longer-term study impacts such as protocol deviations or trial discontinuations. Additionally, clinical trial patient recruitment and enrollment have faced some disruptions.
These challenges have required strategic rethinking around every element of the clinical trial experience from a patient perspective to ensure that critical and life-changing research can continue safely and effectively.
What strategies and practical approaches are you using to manage these operational challenges?
At Parexel Biotech, we’ve implemented a dedicated oversight group focused on assuring project continuity by identifying training and strategies to mitigate the risks and challenges associated with in-person site visits. And we help our partners do the same, using this pivotal time as an opportunity to drive toward a more patient-focused model.
The pandemic has reinforced the need for flexible, patient-centric innovations not only to improve the patient experience, but also to deal with the unforeseen. Where site access is restricted, data-driven remote patient monitoring strategies can be implemented to afford business continuity, subject safety, data integrity and study quality.
Where sites are open for patient visits, travel restrictions can impact patients’ ability or willingness to physically visit a site, necessitating a shift toward e-visits and video dosing regimens. The increasing frequency of such situations has accelerated the consideration and adoption of decentralized clinical trial approaches.
We’ve been a pioneer in decentralized trials and have implemented a range of technologies and patient-centric innovations that enable us to continue facilitating studies amidst changing conditions. For example, eConsent, wearables, telehealth and telemedicine are solutions that reduce the number of patient visits required to participate. Technology and tools such as video calls, patient mobile apps and digital health monitors are also increasingly integral.
We also work with study teams to consider each study and its specific challenges. DCTs require extra measures in supply chain management, for example.
Our supply chain optimization team helps customers that are conducting studies impacted by COVID-19, working alongside them every step of the way to ensure continuity of the supply chain, adjust recruitment expectations if recruitment is still open and determine the frequency of patient visits and site storage capacity. An interactive response technology system can help manage supply chain logistics, supporting site-to-site medication transfer, direct-to-patient shipments from supply depots, and more.
Decentralized clinical trials haven’t always been a preferred approach. Will we see more of them in the future?
Absolutely. One of the pandemic’s silver linings has been the industry’s increasing openness to new approaches, including decentralized trials. Through this model, we’ve been able to keep clinical research moving over the past year.
Parexel has conducted more than 110 DCTs, and we have experience in more than 200 studies with remote patient engagement strategies, such as patient recruitment and retention platforms, e-visits, video dosing regimens and patient insight projects. We’ve worked with over 300 patient apps. And most important of all, we keep talking with patients and have a Patient Advisory Council that helps add patient insight to clinical excellence.
We discovered there were some aspects of DCTs that patients were hesitant to embrace. For instance, some patients didn’t want anyone coming into their home and preferred to visit a nearby clinic or alternative site. This insight enabled us to build this option into the clinical trial, which really resonated with patients.
What are the advantages of expanding the use of DCTs? What are you doing to promote them?
DCTs represent an opportunity to rethink and refresh how research studies are designed and conducted, while keeping the patient at the heart of this emerging paradigm.
When you truly put a patient-centric design into a clinical trial, you have a study that’s compelling for patients and investigators alike. It’s one of the reasons we always recommend our partners start with the patient and keep them at the heart of everything they do, every step of the way. Improved patient recruitment—one of the challenges for clinical research—is probably the most significant ROI associated with this view. But patient retention and adherence are also strengthened by patient-centric innovations. And better retention results in a shorter time to market, bringing the therapy to more patients, faster. And that’s better for everyone, pandemic or not.
These benefits are why we’re involved in various efforts to expand access to clinical trials through DCTs. Parexel is a founding member of the Decentralized Trials & Research Alliance, a new partnership of 50 life sciences and healthcare organizations that will be looking at policies, research practices and digital health technologies in DCTs. We also have initiatives to offer fully virtual and hybrid trial designs, boost clinical trial diversity and educate patients and caregivers to promote awareness about clinical trials and build trust at the community level.
What does the future hold for clinical development operations? How long will the effects of COVID linger?
As a result of the pandemic, we expect to accelerate our current data-driven monitoring approach to a broader, end-to-end risk-based approach to trial planning and execution. This includes upfront planning for risks, leveraging innovative technologies to perform centralized monitoring with data surveillance, and implementing risk-based approaches to SDV and monitoring of sites.
I believe the changes over the past year will be lasting ones. Our responsibility to patients is not to take for granted these innovations we see in the pandemic response. Before COVID, many insurers, including Medicare, did not reimburse for telemedicine. Now they do, and they will likely continue to do so, spurring both increasing technological innovation and higher rates of adoption.
Moving forward, we want to see more consistent and meaningful patient involvement in every study, with the patient being a key stakeholder in planning and decision-making. We have a duty to patients to learn from this experience, continue to innovate, and ultimately deliver better healthcare in a changing world.
For more information, visit Parexel Biotech.