Protocol First’s technology currently is being used in the Leukemia and Lymphoma Society’s (LLS) Beat AML Master Clinical Trial. The collaborative study reaches across different academic centers with simultaneous testing of several novel targeted therapies for older patients diagnosed with acute myeloid leukemia (AML).
Technology offersings from Protocol First offerings include its eProtocol, Source Upload, and Electronic Data Capture system (within one eClinical platform, “P1”), as well as its Electronic Health Records (EHR)-to-Electronic Data Capture (EDC) application, Clinical Pipe. Because the technologies are cloud based, most Beat AML trial activities can be performed remotely via the internet.
Supporting therapies
Amy Burd, vice president of research strategy for LLS and lead for the Beat AML initiative, said Protocol First has helped the organization pursue therapies for leukemia and lymphoma.
“The company’s platform has contributed enormously to the success of this complex trial by helping us efficiently transfer information in real-time between the research centers and our electronic data capture systems. Since 2016, the trial has been able to transfer data directly from patients’ health records into the data capture systems using Protocol First’s Clinical Pipe application, thereby saving precious time for our research and operations staff,” Burd said.
Additionally, Burd explained, the funding LLS committed to Protocol First will lead to benefits beyond the Beat AML project.
“This funding will benefit both LLS and Protocol First as well as the broader industry-sponsored research community that is desperately looking for ways to re-start trials impeded by the COVID-19 crisis,” she said.
Verifying data
According to Protocol First, the technologies have been used for four years on the Beat AML trial, and they offer an optimal solution for trials in the face of shelter-in-place orders that can make it difficult for sponsors to verify multi-center clinical trial data onsite.
In addition to empowering remote access via Source Upload, the Clinical Pipe application is designed minimize errors and reduce the time site staff spend are required to spend performing manual data entry, leaving them to attend to higher-priority work.
Hugh Levaux, founder and CEO of Protocol First, said the effect of COVID-19 on the industry has also affected the company’s business.
“With the impact of COVID-19 on collecting critical trial data, our business is accelerating substantially. LLS funding has come at the right time to provide us the financial capacity needed to rise to greater heights,” Levaux said. “We have been proud to partner with the Beat AML team and greatly appreciate the continued confidence LLS has in us with this funding.”
