2月 4, 2021 By Jason Mieding (5 minute read)
As COVID-19 continues to change how we do business in the biopharmaceutical industry, it’s important to not lose sight of why we do what we do: improving and saving patient lives. The fabric of how we interact with patients is changing, and many functions—such as clinical trials—can no longer depend on traditional, in-person interactions. Whether you’re a large or small biopharma company, if there is one trend that should have you rethinking how you approach clinical trials, it is the shift to patient-centricity.
The trend of patient-centricity isn’t just a shift for clinical trials either—it’s a fundamental change to the entire life science industry. Patient-centricity is a total mindset change, and can mean different things to different people, making it sometimes important to outline and define what patient-centricity is not.
According to an article by Deloitte—Striving to become more patient-centric in life sciences—there isn’t “one standard definition of patient-centricity.” And while companies may even call “patient-centricity” other things—such as: patient engagement, patient-focused, etc.—most industry leaders tend to agree what isn’t patient-centric. According to these leaders, patient-centricity is not:
While it’s important for biopharma companies to form positive alliances and partnerships with other organizations, this alone does not make a company necessarily patient-centric. Becoming a patient-centric company should be an inward, cultural change at all levels of operation, and should evolve a company’s “processes, methodologies, and metrics to drive change.”
Patient—i.e., “subject”—input, for clinical studies is critical, however, it shouldn’t be your entire strategy. Yes, the subject/administer relationship does help make clinical trials more patient-friendly, can quicken enrollment, and get drugs to market faster, but this doesn’t make your clinical trials necessarily patient-centric. According to a Patient Engagement Leader from the Deloitte article, engaging with “patients about clinical trials is not patient-centric if you are just doing the study you want, looking at what you think is important. It’s not interviewing patients to check a box, or cherry-pick what you want to hear, or confirm your bias.”
If there is one thing we should take away from disruptive events such as COVID-19, it is that sometimes, we must go back to square one. That square one is putting the patient experience first. So, every aspect of how we interact with patients should be challenged and it’s important for biopharma companies to be agile and reassess how they conduct clinical trials, in various iterations.
“Patient-centricity is a mindset and behavioral change—it should drive your processes and systems in such a way that improving the patient experience is at the center of everything you do.”
Like many industries, COVID-19 has changed things, and most of these changes are likely here to stay post-pandemic. COVID-19 has revealed that many traditional means of conducting business, can and will be challenged. The reality checks this pandemic has presented us, leaves biopharma and life science companies no choice but to reevaluate how they conduct clinical trials and maintain patient-centricity. Because no matter how challenging this feat may be, there may be benefits—for all parties—to changing up traditional means of conducting clinical trials.
To the forefront of making clinical trials more patient-centric, come decentralized clinical trials. Decentralized trials allow patients to engage with their trials at home for most—if not all—of the study, so it’s no surprise that decentralized trials are one of the hottest topics in the biopharma industry. Although decentralized trials aren’t a new concept, they’ve garnered new respect from the industry for exceeding expectations.
When COVID-19 shutdowns threatened drug development programs, nearly three out of four biopharma companies modified traditional protocols to adopt some form of decentralized studies. To the industry’s relief, decentralized trials prevented clinical trials from grinding to a halt by bringing study drugs and care directly to patients in their homes.
Furthermore, it turns out that decentralized trials have also been making it easier for sponsors and clinical sites to recruit patients to participate in studies, and for patients to remain enrolled in studies until they conclude. This is welcome news for drug makers, considering that 85 percent of trials fail to recruit and retain enough patients to meet enrollment timelines, and 19 percent of registered trials are terminated because they fail to enroll enough patients.
It’s logical that making it easier and less time consuming for patients to enroll and remain enrolled in trials would have a positive impact. One in three patients who enters a clinical trial drops out before the study concludes, citing the burden of time and travel to a clinical site.
By enabling patients to participate in clinical trials from their homes and requiring few or no site visits, decentralized clinical trials decrease the burden of participation for patients and their caregivers. The result:
In a year that has been dominated by COVID-19, biopharma companies are characterizing decentralized studies as the silver lining. Having gained a foothold in the industry, these trials are here to stay. More than 90 percent of respondents in an industry survey anticipate increased long-term adoption of decentralized studies.
While biopharma companies can set up their own decentralized clinical trials, this process could take a company up to one and half years to get off the ground—depending on the scale. Industry leading CDMOs can help alleviate the complexities of dispensing Investigational Medicinal Products (IMPs) by centralizing control and simplifying supply chain planning by providing both large and small biopharma companies with a holistic, Pharmacy-to-Patient, and Depot-to-Patient solution. This type of robust and flexible solution can not only ensure drugs are delivered to patients on time, but further ensure waste is reduced and storage space at clinical sites is minimized.
An experienced CDMO, with the right expertise in decentralized clinical trials, can reduce your study’s start-up time to only a few months and should be able to provide tangible evidence of their capabilities. This type of partnership will ultimately allow you to focus on improving your IMP so you can better develop your life-improving and life-saving product, quicker.
To find out more about the positive impact of decentralized trials and how we’re partnering with sponsors to execute them, please download our eBook entitled “No Place Like Home: How to Make Decentralized Trials a Win for Patients, Sponsors, and Investigators.”