What Sponsors and CROs Are Demanding from Decentralized Clinical Trials
One top clinical research organization (CRO) says that around 70% of all the clinical trials they conduct involve at least one aspect of a decentralized clinical trial (DCT). And that number may be conservative given that the COVID-19 pandemic has highlighted—and in many cases, necessitated—elements of DCTs and their benefits for conducting clinical trials for both CROs and sponsors.
Decentralized clinical trials can include one or more of the following patient engagement components: eConsent, electronic patient reported outcomes (ePRO), telemedicine, wearable sensors to gather data from a patient, and delivery of study medication, devices, or other supplies directly to patients through a randomization and trial supply management system (RTSM).
No matter what elements are used in a clinical trial, DCTs often incorporate novel technologies to drive better patient engagement, increase patient access to clinical trials, and ensure patient safety, according to Michael Tucker, Senior Product Solutions Specialist at Medidata Solutions.
“By giving a patient options on how they want to participate—whether at a trial site or remotely—a study team can improve the success of patients complying with the protocol and make it more convenient for them to participate in your clinical trial,” he says. “There are multiple definitions of what DCTs are, which can often be confusing when you are discussing DCTs.”
Many times, sponsors are looking for an education on what DCTs actually encompass in practice, and providing them with real use cases helps to clarify what they are looking for.
“When a CRO or sponsor wants to start working with DCTs, typically one of the first questions they ask is: ‘what can a company offer from a technology perspective to support the protocol,’” says Hugh Caplan, Sales Solution Specialist for Medidata mHealth products, virtual platform, and DCT platforms.
In addition, tech vendors should not only have the technology, but they should also be familiar with the regulatory landscape in which the technology is deployed. For example, Caplan says that a sponsor may want to deploy eConsent in countries they will conduct trials in, but it is up to a company like Medidata to know which ones will accept electronic signatures and which ones won’t. When it comes to ePRO, sponsors and CROs also need to know country-specific regulations, such as how questions are worded and the impact of screen sizes on questions, as well as ensuring data and information from patient diaries are entered correctly.
Tucker says that a difference between CROs and sponsors is that while the CRO is often just looking for part of a technology platform to support their operational services on a study, a sponsor may be looking for the whole solution. “Our role is to look at their protocol and determine the level of virtualization and decentralization that is appropriate, as well as advise the client or partner on ways they can streamline their study to be more patient-centric. Most often, there is some level of hybridization that can be applied between running a traditional site-based clinical trial and a fully decentralized clinical trial that will serve the needs of both the patient and the sponsor. We call this, ‘turning the trial dial’ to tune up the trial with the right amount of virtualization.”
Tucker adds that while many sponsors and CROs are familiar with the elements of DCTs, they are less familiar with the rules and regulations surrounding them. Adhering to them is critical to the success of a trial. As an example, he cites remote eConsent and ePRO as potential challenges since many regulatory authorities want confirmation that the person who is signing a consent form or logging in data is actually the person enrolled in the trial. This requires a methodology for ID verification to be supported in your solution.
“You need to have verifications tied in at the beginning with electronic informed consent, through ePRO to capture data from patients, such as a diary or a questionnaire,” he says. “Appropriate security and verification methods need to be built in for data integrity, which may include edit checks to ensure you are not making mistakes.”
Medidata offers a suite of tools, including myMedidata eConsent, myMedidata eCOA, Rave RTSM, Rave EDC, Remote SourceReview, Targeted Source Document Verification, and others to seamlessly support DCTs. Just as important as collecting data is performing analytics on it. Medidata has that covered too.
“Once the data goes into Medidata Clinical Cloud, then you’ve got the [artificial intelligence] that analyzes the data in real-time,” Caplan notes. “That’s then sent out to the study teams. We are engaged in not only the collection of data, but consuming the data as well. That distinguishes us.”
Both Tucker and Caplan agree that the COVID-19 pandemic was a watershed moment for further adoption of DCTs in the industry.
“When COVID hit, everybody started asking for what we had been proselytizing for the longest time,” says Tucker. “The biggest requests that came in were for telemedicine and remote consent.”
DCTs often include sponsor-facing technologies to streamline the management and oversight of the trial. In response to demands from CROs and sponsors, as well as in light of new guidance and regulations, Medidata launched a new product during the pandemic: Remote Source Review, which gives monitors the ability to look at trial documents remotely.
“We introduced [this product] based on technology that we already had in-house that allowed sites to scan and upload these documents into a system and then have the monitor complete a secure review remotely,” Tucker says. “Now the site and the monitor could look at these documents remotely together and have queries back and forth. That made a big impact on our clients during the pandemic.”
Another change made during COVID was a modification to the RTSM that allowed trial drugs and supplies to be shipped directly from a depot to a patient. This technology is now incorporated into the myMedidata platform so patients can track the shipments and the sponsor or CRO can confirm they have been received.
Telemedicine capabilities were also improved, giving sponsors the option to have secure, one-on-one conversations with patients. “We’ve now standardized that and built it into our myMedidata platform and have allowed patients to initiate a conversation—even during the consent process,” Tucker says.
The research industry continues to change and adapt to address the way people become accustomed to sharing information. With the proclivity for using mobile technologies to conduct everyday business transactions like banking, messaging, making purchases, and scheduling events, patients have developed a comfort with technology and an expectation that these same types of tools can be used to participate in a clinical trial. CROs and sponsors are responding and looking to industry partners like Medidata to lead the way in delivering dependable solutions that address patient expectations and comply with changing industry regulations.