Accelerating Toward a New Era of Clinical Research
Contributed Commentary By Henry Levy
July 23, 2020 | There is industrywide urgency to initiate and expedite new trials as companies race to develop vaccines and treatments for COVID-19. At the same time, there is a need to keep existing trials on track to get medicines to patients. The pandemic, however, has caused significant disruption. Nearly 100 companies have reported disruption of their clinical trials and nearly 1,500 studies have been affected.
Amidst this urgency, companies are struggling to speed trials. Conducting a study today is no faster than it was a decade ago, averaging six to eight years to develop a new product. Paper-based documents and departmental silos are holding trials back. There’s tremendous innovation happening in the industry but using manual processes to get advanced therapies to market is like getting a Mars rocket ship to the launchpad with a horse and buggy.
The industry is rapidly modernizing its systems and processes to break down barriers and run faster studies. Sponsors, CROs, and sites are looking for simpler ways to share information and make it easier for patients to participate in new trials, from enrollment to treatment.
Organizations are adopting new virtual, remote, and digital ways of working to accelerate clinical research. Looking ahead, the modern trial of the future will reduce the patient burden, speed drug development, and improve how stakeholders work together during the course of a study.
Reduce Patient Burden with Virtual Visits and Remote Care
Trials place a heavy burden on patients. Some require 20 or more onsite visits to provide care or complete a check-up, a challenging request for patients who travel long distances to sites. For patients that endure severe illness and experience side effects, the extensive travel requirements are even more difficult. To alleviate the burden and improve participation in trials, the industry is digitizing processes to enable patient-centric methods.
Digital solutions enable sites to digitize patient information through remote data capture, patient adherence, eConsent, and more to reduce the patient burden when participating in trials. Solutions that support virtual visits allow patients to attend check-up appointments from the comfort of their own home. The digitization of processes also makes it easier for patients in more rural areas to participate in studies.
Patient-centric methods make direct-from-patient data more accessible. Device monitors and wearables like smartwatches make it easy for patients to share information on vitals, side effects, or symptom changes without seeing a doctor. With remote care, clinical trial information is made available to patients online, keeping them engaged and up to date on study progress.
The digitization of patient care is redefining the patient-centric clinical trial. Sites now have the digital infrastructure and processes to increase access, participation, engagement, and communication to improve overall patient satisfaction.
The Move to Digital to Speed Trials
Today, sites rely heavily on paper and manual processes that slow study execution. Data is captured on paper, manually entered into an EDC, and stored in paper format to maintain compliance. There is, however, change under way as the industry recognizes the benefits of digitizing.
In March of 2018, the FDA released ICH-E6(R2) updating their guidance and incorporating the technological advancements available to the industry. The guidance provides clinical sites with digital alternatives that can help to accelerate the research process.
eSource, an electronic source for capturing data, can significantly speed trials by digitizing a process that was manual and paper-based. It also can improve the experience for sites by prioritizing patient care over administrative tasks and information requests. Digital solutions like eSource enable sites to standardize processes and capabilities, improving study execution and inspection readiness.
As organizations continue their move to digital, advanced cloud-based solutions are driving improvements in collaboration by providing widespread access to data across study stakeholders. Research sites conducting study site monitoring, for example, benefit from remote access to clinical trial data. Instead of investing time and resources to send monitors onsite, monitors can access, review, and collaborate on content online easier and faster.
The reliance on paper in trials is quickly changing as the adoption of digital solutions grows. Without tedious paper-based processes, sites can speed trials by spending less time on administrative tasks and more on study execution.
Improve Collaboration with a Connected Clinical Trial Landscape
People working better together can be the key to running efficient trials. Independent teams manage patients, site operations, and pharmaceutical requirements. Aligning stakeholders on processes and collaboration builds efficiencies that ultimately speed studies.
A unified and connected clinical trial landscape across sponsors, CROs, and sites makes it easier to share information. Sponsors can gather feedback from sites on study feasibility quickly, spending less time coordinating surveys. They can also distribute safety letters faster to notify global sites and regulators of an adverse event and get real-time updates on patients from enrollment to treatment.
Real-time visibility into study progress, milestones, and metrics enable sponsors and CROs to make more informed decisions. For sites, streamlined collaboration frees up time that now can be allocated toward patients.
Connecting studies across stakeholders improves essential document exchange and collaboration, making trials more efficient and effective. The biggest benefit is the shift of focus from administrative tasks to patients and medicines. That is what delivers transformational performance in clinical trials.
A New Era of Modern Clinical Trials Will Accelerate Clinical Research
The industry is making it a priority to modernize trials with unified and connected digital solutions. Former FDA Commissioner Scott Gottlieb, M.D. outlined the opportunity in a 2019 statement:
“Modernizing clinical trials is an agency wide priority,” said Gottlieb. “Efforts to streamline medical product development can be frustrated by legacy business models that discourage collaboration and data sharing, and the adoption of disruptive technologies that make clinical research more effective.”
The emergence of COVID-19 accelerated the life sciences industry’s modernization efforts. Sponsors, CROs, and sites are moving fast to digitize processes to meet the requirements of the post-COVID operating model focused on speed, execution, and patient centricity. The ways of running studies in the past will evolve into a new digital, remote, and connected clinical trial that lifts the patient burden of participation, digitizes paper-based processes, improves collaboration among trial stakeholders, and accelerates clinical research.
Henry Levy is General Manager, Vault CDMS, site, and patient solutions at Veeva Systems. Henry has spent 25 years working to transform how the life sciences industry improves patient health. At Veeva, he is making it easier for sponsors, sites, and CROs to work together during clinical trials, as general manager of Vault CDMS, site, and patient solutions and representing Veeva as president of Align Biopharma and Align Clinical CRO. He can be reached at firstname.lastname@example.org.