Clinical Researcher—June 2022 (Volume 36, Issue 3)
PRESCRIPTIONS FOR BUSINESS
Bree Burks, RN, MSN
Clinical research sites are under more pressure than ever to move faster and be more efficient. Without the right digital tools, it is challenging to keep pace while maintaining quality. Labor-intensive processes, large volumes of paper documents, and ever-increasing operational costs can create a cumbersome approach to clinical research management.
Despite these operational inefficiencies, many sites are reluctant to explore new technologies since their biggest challenge is having too many systems with different processes and logins.{1} Sites use a mix of their own technology and sponsor applications, so staff often have to duplicate work or maintain complex integrations across two environments.
A digital clinical trial brings together study stakeholders, linking sponsors, sites, and patients for seamless information exchange. To advance toward this reality, site-centric technology is unified with sponsor systems for clinical operations, data management, and patient-facing applications. For example, an eRegulatory system (or electronic investigator site file [ISF]) that connects to the sponsor’s electronic trial master file (eTMF) can be used for all studies. This would help sites streamline site operations and decision-making, enable easy collaboration with sponsors, and deliver a better patient experience.
Moving beyond function-specific solutions can enable a more connected, digital clinical trial. Here are four ways this can streamline processes to boost efficiencies for sites.
1) Improve the Site and Sponsor Relationship
The transactional nature of clinical trials is slowing down processes. For example, 78% of sponsors and contract research organizations (CROs) still use e-mail to exchange information with sites during a trial.{2} The widespread use of e-mail makes it hard to keep track of activity and leads to multiple requests for information, missed messages, and duplication of effort. Add to that paper shipments, file shares, and portals, and the coordination of information exchange gets more complex.
Lorena Gomez, global head of study start-up, patient-reported outcome (PRO) management, and digital implementation at AbbVie, understands the challenges sites face working across studies with multiple systems. “Site personnel likely receive several requests from a sponsor asking for the same documents. That is not site-centric and leads to uploading multiple copies of the same documents into the electronic trial master file (eTMF),” she says. “A unified digital clinical trial platform can eliminate these manual, redundant requests, enabling more focused, meaningful conversations between sites and sponsors at the beginning of the study.”
A digital clinical trial that brings together site- and sponsor-owned systems can significantly reduce e-mail traffic since most requests can be digitally executed or automated. This improves communication across stakeholders and reduces frustrations with duplicate information requests or last-minute scrambles to search e-mails and find documents. When sites and sponsors work better together, communication is elevated beyond transactional requests, leading to a stronger relationship. Some sites are already experiencing time-saving benefits from a single system.
“Using a unified system helped us reduce e-mail communication significantly,” said Jim Sanders, president of ClinOhio Research Services, LLC. “During study start-up, we went from sending about 140 to 150 e-mails to the sponsor to only sending 30 to 35, improving our overall communication during the study.”
2) Optimize Site Operations
Digital clinical trials can simplify information sharing to improve site operations, free valuable time for site staff, and speed study start-up. This is critical to accelerating trials because 61% of trial lifecycle times are spent on early trial processes.{3}
For example, when a site receives a start-up package, documents are accepted and auto-filed within their eRegulatory system. Study teams can then route documents for training, collect signatures, and share completed documents with the sponsor seamlessly. With no additional work or custom integration, CVs, medical licenses, and certifications sync automatically to the sponsor’s eTMF.
Completing these tasks within a connected, site-centric system powers more intelligent reports that automate reconciliation and provide visibility into key metrics, like expiring documents, open tasks, and outstanding signatures. “Our eRegulatory app is much easier to use, allowing us to move faster, and the sponsors like it because they know they’ll have real-time information at their fingertips,” adds Sanders.
3) Standardize the Way Sites Work with Sponsors
The typical research site works with 12 different systems to collect clinical research data,{4} but this isn’t a sustainable way to work. Sites need ways to reduce multiple technology trainings, logins, and passwords to streamline processes during trials.
A site-centric system that connects to sponsors centralizes information for standardization across studies. Using a standard eRegulatory system to complete tasks and share documents reduces training and administrative burden. It also ensures the ISF is consistent across sites and studies.
Standardizing processes can reduce the time spent reviewing the ISF and reconciling documents, allowing study monitors to focus on value-add activities such as site processes and safety reviews.
4) Provide a Better Patient Experience
While COVID-19 accelerated the move to decentralized trials, it underscored the importance of the holistic patient experience. Digital clinical trials can significantly enhance the patient experience by improving the consent process and delivering greater convenience.
“The implementation of digital solutions will allow the industry to minimize the amount of time and commitment that patients have to spend in an office,” says Gomez. “That’s better for the patient, site, and sponsor.”
An end-to-end digital platform with connected applications allows for seamless, automated workflows. The sponsor can author a consent form, send it to the site, get it approved by the institutional review board, and signed by the patient in one activity flow. The benefits include a more informed and engaged patient throughout the trial, enhanced access to more diverse patient populations, better tracking of patient consent forms for sites, and greater visibility into the consent status for sponsors.
Enabling a More Connected, Digital Trial
The rapid shift to decentralized trials during COVID-19 highlighted the need for better management of documents and data through direct digital connections that link sponsors, sites, and patients. The industry is making progress in terms of moving toward digital clinical trials that enable seamless collaboration across stakeholders. This is good news for research site leaders since they will be able to reduce administrative burden and reap the efficiency and time-savings of unified, site-centric systems.
With fewer manual or redundant tasks and more automation, sites can improve operations, simplify their work with sponsors, and better care for patients. At the same time, sponsors can access information in real-time and have confidence documents are always current. A digital and connected study advances the industry, shifting processes from being paper-based and manual to digital and automated. As research sites capitalize on the efficiencies of unified systems, they play a critical role in accelerating clinical development for patients in need.
To learn more about this topic, visit the ACRP 2022 Online Conference Library and look for the sessions on “Working Better Together: How Technology Brings Sites and Sponsors Together” and “Embracing a New Technology Era in Clinical Trials: How Digital, Connected Trials Transform Site Operations.”
References
- Society for Clinical Research Sites. 2019. Impact Assessment of eClinical Technology and Industry Initiatives on Sites. https://myscrs.org/learning-campus/white-papers/
- Veeva Systems. 2020. Unified Clinical Operations Survey Report. https://www.veeva.com/resources/clinical-operations-survey-report-2020/
- Tufts Center for the Study of Drug Development Impact Report. 2018. https://csdd.tufts.edu/impact-reports
- BioSpace. 2016. New CenterWatch Inc. Study Finds That E-Clinical Technologies are Increasing Investigative Site Work Burden and Performance Inefficiencies. https://www.biospace.com/article/releases/new-centerwatch-inc-study-finds-that-e-clinical-technologies-are-increasing-investigative-site-work-burden-and-performance-inefficiencies-/
Bree Burks, RN, MSN, (bree.burks@veeva.com) is Vice President of Strategy, Site Solutions, Veeva Systems. She has more than 12 years of academic medical research experience supporting hundreds of trials spanning all translational stages in sponsor and site settings.
