3 steps to more connected clinical trials

Nothing is constant except change, and medtech’s no exception. Industry regulations such as EU MDR and IVDR continue to evolve, requiring data collection and analysis on a much larger scale. Therefore, more studies are needed with contract research organizations (CROs) and sites to capture the necessary data for new products and post-market performance.

Ongoing industry changes, paired with disruptions of COVID-19, have brought to light inefficiencies in how trials are run. Manual and paper-based processes increase the burden on patients and research sites and ultimately slow study execution. But positive change is happening, and more companies are accelerating transformation efforts and embracing digital clinical trials.

Here are three key steps you can take to unify study stakeholders in trials and help accelerate product delivery to patients.

1. Seamless information exchange with research sites

Most companies are still using manual approaches, with 78% reporting they use email, 40% use document shipment, and 38% use dedicated portals.¹ These traditional ways of collaborating increase administrative effort and lead to data silos across the trial ecosystem.

Bringing together clinical operations with site-facing solutions allows for real-time document management and greater visibility into study status. Automating information exchange across internal and external stakeholders can simplify usually manual processes such as safety letter distribution and study closeout transfers. Supporting a seamless flow of information makes clinical research collaboration easier and more effective.

This approach is essential because fewer sites run trials for medical devices than for pharmaceutical therapies. Adopting digital solutions can improve a site’s engagement and drive better patient adherence in studies.

2. Adopt decentralized approaches

Recruiting qualified patients for clinical trials is challenging, but it can be difficult to get patients to stay in a study until the end. Typically, nearly one-third drop out² due to travel requirements, multiple site visits, and time commitment. Each patient dropout in medtech studies is a significant hit on trial quality. Add the challenges of recruiting a diverse patient population, and losing a qualified patient hurts even more.

Decentralized approaches, which kept clinical trials on track during the COVID-19 pandemic, make it easier for patients to participate and stay in trials. During the past 18 months, the number of physicians using telehealth grew from 22% to 80%.³ Virtual visits and other digital solutions empower patients to complete study activities where they feel most comfortable and have more flexibility.

eConsent is also transforming a manual, paper-based method to simplify the process for patients and improve their comprehension of study protocols. Decentralized approaches break down the barriers of paper and location in studies, making participation easier for patients and expanding a study’s reach.

3. Bring clinical data management, operations together

Historically, clinical studies have not been agile. Even the slightest protocol change may delay trial database lock for weeks. Using disparate systems leads to process gaps, inefficiencies, and siloed data that slow trials and increase development costs. Bringing together clinical data management with clinical operations allows medical device and diagnostic companies to execute trials faster, from database build to study closeout, while maintaining compliance.

The industry is embracing this approach because regulations require an increasing amount of clinical data analysis and for a longer timeframe. Post-market clinical follow-up on devices such as hip implants and stents are lasting a decade after patients start using them.

Connecting data and operations eliminates transcription errors and duplicate data entry. The ability to access and share information across systems streamlines processes and increases efficiency for all teams involved. Medtech companies are taking action to put this into practice. Gala Therapeutics, a fast-growing company with an extensive portfolio of innovative pre-market products, is unifying clinical trials on a single cloud platform.

“Being able to run trials end-to-end on a connected system provides the visibility and control to speed our total product life cycle,” says James Stambaugh, senior vice president of clinical affairs and strategy at Gala Therapeutics.

Long-term digital strategy

Adopting new technologies in medtech has been challenging and has led to heavy reliance on manual and paper-based processes that can cause delays in critical areas such as trial master file (TMF) management. During the pandemic, medtech companies adopted new ways of working remotely to keep trials going, opening industry leaders’ eyes to what’s possible.

An effective digital strategy that spans the entire clinical trial ecosystem enables better collaboration with CROs and sites and helps maintain consistent inspection readiness. As conditions improve, start with clinical trial operations most reliant on paper and manual data entry, and pay close attention to how information is being shared.

Include the necessary technologies, partners, and resources in your digital strategy to meet the needs of research sites and patients. In addition, improvement efforts should consider the experience of everyone involved across the trial ecosystem to drive better collaboration across teams and increase process efficiency.

Digital technology is at the core of better clinical trials and closer connections among sponsors, CROs, and sites. As more medtech companies embrace new approaches to communication and document sharing and adopt more patient-centric practices, the future promises better patient experiences, reduced clinical trial attrition, and accelerated delivery of innovative products to market.

Veeva MedTech
https://www.veeva.com/products/ medical-devices/

About the author: Kevin Liang, Ph.D., is senior director of clinical strategy at Veeva MedTech. Liang leads the clinical initiatives for the group, working with internal teams and customers to develop best-in-class cloud-based solutions for medtech trials. He can be reached at kevin.liang@veeva.com.

1. Veeva Systems, Unified Clinical Operations Survey Report, 2020; 2. Clinical Leader, Considerations for Improving Patient Recruitment in Clinical Trials, 2012; 3. Beckett’s Hospital Review, Physician Telehealth Usage Increases 58% since 2019, Survey Finds, 2020