While interest in decentralized clinical trials (DCTs) has been heating up lately, the reality is that DCTs have been on the back burner of most clinical research organizations (CROs) for years. Long before COVID-19, technology vendors were developing tools to streamline clinical trials, including electronic consent (eConsent) forms and other ways to electronically capture data. In these early days of DCT technology, the primary drivers were somewhat mundane: paper reduction and regulatory compliance.
Then COVID-19 struck. Suddenly, CROs and trial sponsors were sent scrambling to re-engineer clinical trial protocols to accommodate an overburdened healthcare system and an almost complete moratorium on non-essential medical visits. DCT components rapidly changed from “nice to have” to “need to have.”
To accommodate the new reality, the FDA provided guidance and loosened some reviews and approvals, so the sponsors could act quickly. Some CROs and sponsors initially turned to un-validated online collaboration tools to facilitate trial activities before taking the time to evaluate what could be done digitally and remotely.
Fast-forward a few years (gladly, you say) and the conversation around DCTs is shifting again. With the moratorium on in-person visits lifted and patients more comfortable leaving their homes, the healthcare industry is stepping back from the urgency of remote patient engagement and asking themselves which DCT processes are really the best path forward for clinical trials.
Over the last few years, DCT tools such as eConsent, electronic patient-reported outcomes (ePRO), and electronic clinical outcome assessments (eCOA) have become viable options for traditional and hybrid trials. While there are some challenges related to existing processes at some sites, there is value in having these DCT elements part of a unified system. This cuts down on the number of integrations and distinct systems to log into. Additionally, patients appreciate the convenience of performing tasks online and CROs appreciate the streamlined data collection process.
That said, there is less consensus around whether wearable devices and other newer technologies will gain the same kind of traction in clinical trials. In the case of wearables, for example, there is well-placed concern over quality of data. What happens if a six-year-old child picks up a medical device intended for their parent and corrupts the data collection? Or what about patients who don’t use the device correctly and take it off at night against clinical direction? These types of data quality issues can undermine the benefit of having vital signs and other health-related data streaming on a steady basis (as opposed to a monthly snapshot taken at the clinical site).
A broader question is the patient’s comfort level with digital technology. Older patients, for example, may prefer to have their vital signs recorded at the clinical site by a healthcare professional. Other patients may be averse to new technology but comfortable using an app on their phone to record vitals and notes. And then there’s the impact that DCT processes may have on the clinical staff supporting the trial. It’s reasonable to expect that some level of additional training will be required before staff can replace traditional data collection methods with software-based DCT solutions.
Adding to the confusion surrounding DCT best practices is the chorus of different voices within the clinical research trial ecosystem. Foremost perhaps are the trial sponsors themselves, who have a vested interest in accelerating trial processes, reducing costs and drawing from a wide pool of patients. For them, DCT technology is particularly attractive — so much so, in fact, that sometimes sponsors will recommend DCT methods even when they’re not the best solution to the problem.
Patient comfort and convenience is obviously critical to the success of clinical trials as well. Not every patient perceives comfort and convenience in the same way. For some, tele-visits will be far more convenient than site visits. However, for the treatment of serious or chronic diseases, patients may prefer to meet face-to-face with a healthcare professional to report any discomfort or unusual events. The objective is to provide flexibility for a broad patient population, so that the trial is as convenient and inclusive as possible.
Finally, some CROs have taken the step of hiring independent DCT consultants to help select which types of decentralized processes and tools are optimal for each trial. The risk here is that DCT expertise can quickly become outdated. DCT vendors are more likely to be on the cutting edge of new technology, but vendors also tend to tout their own solutions first — sometimes to the exclusion of other vendors, which can limit innovation and escalate costs.
Every trial is unique, yet reinventing the wheel each time is no way to get your trials moving. CROs need repeatable, reliable processes that mix and match the best of traditional and digital, centralized, and decentralized processes. Unified platforms that offer electronic data capture, eConsent and ePRO/eCOA can minimize complexity, greatly reduce the effort associated with protocol amendments and streamline the experience for site and participants.
DCT methods can also impact recruitment and retention. Offering patients the option of loading an ePRO or other data collection app on their phone, for example, may appeal to a wider population of patients. However, there may be subjects who prefer not to install an app on their phone for the trial. Having an option for web-based data entry or an available provisioned device meets the needs of more patients. Also, building trial protocols that support both remote patients who live more than 10 miles from a testing site (via decentralized electronic reporting) plus local patients (via site-based monitoring) could become a repeatable process for trials that require a broader pool of candidates.
When CROs and sponsors began implementing DCTs at the start of the pandemic, the first step was to identify what could be done remotely and what tools could be used to make it possible to continue trials. The next step was to implement tools that enabled more to be done remotely and also better addressed efficiency and compliance issues.
As we move to the next phase of the pandemic, we are similarly proceeding to the next stage of DCT adoption: What should be decentralized and how should it be done to maximize efficient collection of data from a variety of sources?
At Zelta, our goal is to support CROs as they seek the most appropriate solutions while providing technology that enables repeatable methods to conduct trials across a spectrum of diverse sites and include a diverse set of participants. Because at the end of the day, the best solution is the one that best fits everyone’s needs.
Decentralized clinical trials are becoming an industry norm. This ebook explores necessary consideration and unique challenges of designing a decentralized trial, including ways to maximize success, considerations for patient centricity and how to implement technology adaptions.
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