The Next Big Step Toward a Collaborative Clinical Trial Ecosystem: Three Perspectives

Highlights from Veeva's Innovation Theater presentation at #DIA 2020. Veeva's Jason Methia is joined by Garrick Myers, Vertex Pharmaceuticals, Inc., and Rachel Sheppard, University of Louisville in a lively and informative discussion about opportunities to streamline information sharing for faster trials and improving the site and patient experience

Industry Challenge
Jason Methia, Veeva Systems

Modernizing clinical trials is an industry-wide priority, yet efforts to do so have been hindered by disconnected systems and processes that slow study execution and make information-sharing difficult and cumbersome.

A prevailing industry challenge is that information sharing remains largely manual, transacted via email, paper shipments, and investigator portals. Each of these involves low-value, high-volume manual effort to send, receive, ship, upload, and download materials between systems, creating inefficiencies and administrative burden. One research center reports that 70% of coordinator time is spent responding to redundant emails and queries rather than interacting with patients.

Another ongoing challenge is the substantial burden placed on patients to participate in trials. Trials are difficult to find and join, and once enrolled, patients must often travel long distances to participate. Engagement with the research team is typically one-sided, oriented to the needs of the trial rather than patient ease and convenience.

The emergence of COVID-19 created an urgency to keep existing trials going, expediate new trials for the virus, while continuing to deliver a safe environment for patients, healthcare workers, and clinical researchers.

Several new Veeva applications will help the industry break down barriers in running clinical trials. With Veeva SiteVault, Veeva Vault Site Connect and MyVeeva for Clinical Trials, sponsors and sites can work better together and make it easier for patients to participate:

• Veeva SiteVault Free is a free eRegulatory solution for clinical research sites. It replaces manual and paper-based regulatory processes by providing a modern cloud application to manage investigator site files in compliance with 21 CFR Part 11 and HIPAA requirements. With SiteVault Free, all sites have access to advanced technology that helps them run their operations
• Veeva Vault Site Connect connects sponsors using Veeva Vault Clinical applications with sites using Veeva SiteVault (a compliant eISF application used by sites for source document management and remote monitoring) to automate the flow shared information associated with clinical trial collaboration and removing mundane activities from trial execution.
• MyVeeva for Clinical Trials is a free application for clinical research sites and patients with capabilities for virtual visits, patient adherence, ePRO, eConsent, eSource, and an easy-to-use multichannel patient portal. The new application will make it easier for sites to deliver a patient-centric and paperless clinical trial experience.

Together, these new applications will make clinical trials more efficient and collaborative. From enabling sites to run their operations, to speeding of flow of information between sponsors and sites, and better connecting patients to the sites running a study, we are bringing everyone together to drive greater efficiency in trials and accelerate the industry's move toward patient-centric healthcare.

Sponsor Insights
Garrick Myers, Vertex Pharmaceuticals, Inc.

Improving collaboration and automating high-volume, low-value interactions - these are challenges I've been passionate about solving for years. If anything, they've gotten worse during the past decade, probably because they were not the focus of industry efforts. In my view, the current environment creates an urgent opportunity for all of us to put our energy towards meeting these challenges.

Clinical trials have three primary stakeholders, the sponsors, the sites, and the patients. Together, they are the trifecta that makes the world of clinical trials go round. Optimization strategies also come in a set of three. The first has to do with offering more choices to patients and sites. The second relates to simplifying operations to go faster. And the third concerns the concept of lean innovation, like the Six Sigma models used in manufacturing. Let's explore each of these strategies separately:

Designing for choice. Trials should be virtualized to offer patients and sites more choices. Trials can go fully or semi-virtual, with a combination of traditional and virtual visits. For this to happen, key enabling technologies need to be deployed, such as ePRO, eConsent, telemedicine, and wearables. Several questions need resolution: How much of this is feasible, in what timeframe, and whether these innovations can be introduced without further burdening sites and patients.

Simplify to accelerate. The essence of this principle is doing more with less, that is, finding ways to reduce the complexity of technology architecture. Single points of data capture must be identified so that high-volume, low-value tasks are performed just once, after which data can be accessed by everyone. In this way, all stakeholders' time gets liberated for more productive and valuable work.

Finding your waste. Daily workflows proceed at a rapid pace. But to improve operations, it's necessary to occasionally pause, step back, and take the time to understand how you're actually doing the work. Map out technology interactions and data flows to pinpoint redundant tasks and manual procedures that can be automated and simplified. This is an iterative exercise we've run through several times, and on each occasion, it has paid dividends.

A Clinical Research Site Outlook
Rachel Sheppard, University of Louisville

The COVID pandemic has had a major impact on our site. All non-essential research had to be halted. No external visitors were allowed, preventing monitors from coming to campus. Non-essential participant visits were also precluded.

Technology was central to our ability to keep things moving forward. While we were far from fully prepared for the pandemic, the transition to remote work was smoother than expected, aided by the many tools we had readily at our disposal. As we progress toward resuming clinical operations, several considerations need to be taken into account.

Barriers to technology adoption. When it comes to new purchases, we are constrained by limited financial resources and a lengthy and convoluted vetting process. Also, as a state entity caring for patients, we're bound by rules, regulations, and practices that impact many facets of technology such as IT security and data ownership. The upshot is that sites need to proceed selectively in terms of technology adoption and speed.

A patient-centric approach. One of our main priorities is making trials more efficient and convenient for participants. Solutions such as electronic consent, telemedicine, and local labs have enabled us to begin recruiting remotely. However, many patients don't have a smartphone or computer at home to use for trial participation. Some have visual and hearing impairments that limit their ability to use technology. In more than a few cases, a solution is too complex to learn on their own and requires a good deal of coaching. All these concerns must be factored into choices of new technology to roll out.

Sponsor/site collaboration. Technology decisions are usually driven by sponsors and their business requirements; the industry responds accordingly. But ultimately, technology solutions must fit and integrate with our needs too. When various sponsors use many different technologies, this creates problems for sites. Site coordinators are already challenged with administering a daily load of numerous active clinical trials. Having to learn tens of different systems - and track which ones go with which projects - escalates complexity to the point where it can become unmanageable.

Some of these barriers have been overcome as the COVID crisis puts a premium on rapid adaptation to change. Effective collaboration has increased, sites are gaining more of a say in technology choices, and sponsors are acquiring better knowledge and appreciation of our needs than in the past.

Summary

As we've seen, sponsors, sites, and patients each have important issues, concerns, and imperatives. But all agree on the common goal of moving forward quickly to modernize clinical trials. The industry needs to take a fresh approach to how technology is deployed, how stakeholders collaborate, and how administrative tasks can be simplified and automated. Building on the experience gained during COVID-19, we can and should begin designing studies for choice, with careful attention given to the needs of patients and sites

Interested in learning more? Watch the webinar replay.