The Ever-Changing Business Model of Clinical Trials

Where Are the Clinical Trials?

A decentralized clinical trial contains any virtual component that enables a trial to still operate, but just different from the standard brick-and-mortar site trial. A lot has been accomplished over the past two years since our industry experienced a major operational disruption due to COVID-19. The pandemic catalyzed the adoption of decentralized clinical trial components, especially with the necessary and increased adoption of remote and in-home care.

A single new model has not reached its moment where it’s now the standard, and in fact, quite the opposite. The business model is ever-changing due to the vast array of trial execution options. COVID-19, though not without significant operational disruption, has incited more patient and sponsor optionality than ever before. There is a full spectrum of models ranging from fully decentralized, fully centralized, to hybrid trials that bring optionality both to site and patients.

These decentralized component options that enable fully decentralized and hybrid trials will not go away, but rather; trial design options will increase. With the global pandemic still ongoing, Clinical Ink’s consensus is that many of the digital interventions will become permanent. For example, bring your own devices (BYOD) will increase, remote hybrid trials will increase, clinical operations will grow even more complex as a result, and much more.

So, what do all these options mean for clinical trial design? The team at Clinical Ink recently shared their insight to a group of clinical operations professionals at Halloran’s Clinical Operations Retreat for Executives (CORE) in Sonoma, California. Fresh from the event, here are a few lessons to share that illuminate the options and limitations of decentralized trials and ways to reach success.

Clinical Trial Optionality Is Here to Stay

The clinical trial options – fully decentralized, fully centralized, and hybrid – allow for a broad spectrum of decentralized and hybrid-trial designs. And that fully virtual model is slowly and gradually migrating from smaller early-phase and post-approval studies toward larger pivotal trials. But in the near term, many sponsors, investigators, and research-service providers expect virtual trials to remain limited to a narrow set of use cases, like a well-characterized drug with few adverse events.

While most clinical trials are not likely to be entirely virtual, they will use one or more decentralized components based on suitability for their endpoints, patient populations, and treatments. Through their observations, hybrid models will be increasing with the increase of decentralized components to support a trial’s operations.

Before the pandemic, an Industry Standard Research survey in December of 2019 found that 38 percent of pharma and contract-research organizations expected virtual trials to be a major component of their portfolios, and 48 percent expected to run a trial with most activities conducted in participants’ homes. When asked the same questions a year later, the responses were 100 percent and 89 percent, respectively.

Bring Your Own Device Studies – Key Risks and Lessons Learned

Clinical Ink recently worked with a company that launched a Phase III study on a sleep disorder enrolling seventy-five patients at fifty-six sites throughout the US and Europe. In that study, the patients needed 1-3 daily care clinical outcome diary entries for a three-month period. 90% of the patients in the sleep disorder trial brought their own device (BYOD), while 10% of the devices were provisioned to the patients. Some of those that brought their own device used older models and had poor battery life – a key problem that’s often overlooked. Looking at those diary entries, 92% of the patients were compliant with their data entries. As a result, BYOD increased compliance and patient engagement but did not solve for those inevitable BYOD glitches that will arise. Understanding the risks, like poor battery life, will help a sponsor plan ahead and mitigate data risk.

Clinical Ink also conducted a study that compared a BYOD to a provisioned device to the overall data that was captured. There was a high correlation between the different hardware, and the positive results were a direct outcome from having all the screens show the exact same data. In summary, if patients bring their own devices, the sponsor will need a plan in place on evaluating and monitoring those devices to ensure accurate and timely data. Perhaps the solution is a virtual patient concierge service to help with these issues. And, as a result, data retrieved from a BYOD or a provisioned device will likely lead to the same overall data as long as the exact same data is captured from device to device.

Zooming out for a moment, Clinical Ink launched a recent survey and found that 94% of people are willing to use their own phone for a study and the same amount of people know how to download a digital application on their phone. But to provide an effective and efficient experience for the patient bringing their own device, as a sponsor, you’ll need to keep it super simple – do not make the tool complex as patients need to be familiar with the technology in order to get the data and results the sponsor needs for the trial. Remember, whether patients are using a BYOD, a provisioned device, or both modes, ensure the screens capture the exact same data.

Up until recently, the industry has been unaware of the successful drug applications that use BYOD data, causing some concern that regulators will not accept the data. This year though, the industry’s largest BYOD study – for the Pfizer COVID-19 vaccine development – collected primary safety data using a reactogenicity diary completed by patients. This is a promising indicator for future research, and it underlines beliefs that data collected through BYOD can be just as robust and reliable as the data collected using provisioned devices.

The Vast Options Ahead of Us

Looking at the theme addressed in this article – execution optionality – it all comes down to flexible options for sites and patients. Moving away from the standard brick-and-mortar trial to a world with many more options that benefit both the site and the patient sounds ideal. But there are headaches when it comes to shifting to a new operational mode. We have so many more options to select. But as we’ve heard before, no two trials are the same. Every trial is different, meaning, not all decentralized components that work for one trial will work for another. And there will be limitations such as the ones discussed in this article. Knowing those limitations – and the perspectives of your patients – early in the planning phase is essential to leaning into new clinical trial models.

About Clinical Ink

Clinical Ink is a global technology company offering data certainty from source to submission through their Lunexis eSource clinical technology and configurable direct data capture, eCOA, ePRO+, and eConsent modules. Their suite of solutions for capturing and integrating electronic data from sites, clinicians, patients, and caregivers naturally enhances clinical trial workflows.

About Halloran and CORE

Halloran is a full-service boutique life science consulting firm with offerings across strategy and program leadership, regulatory, clinical, and quality practices. Halloran partners with the most cutting-edge life sciences companies to enrich their product development and business growth through their expansive industry knowledge. From early development to commercialization, their flexible and integrated services are tailored to providing the know-how and a team of cross-functional subject matter experts to propel organizations further. Because of their commitment to their clients and their patients, clients choose Halloran time and time again.

The Clinical Operations Retreat for Executives (CORE) was launched in 2004 –an invitation-only meeting that brings together an exclusive group of senior leaders in clinical development to discuss and debate the most pressing issues around the business of product development and building enduring companies in this space. This conference is a one-of-a-kind peer roundtable where executives learn from each other and share best practices. CORE is hosted by Halloran Consulting Group and founded by Laurie Halloran.