Protocol First has received a funding commitment from The Leukemia & Lymphoma Society (LLS) to help advance the Beat AML Master Clinical Trial (Beat AML), which seeks to evaluate several new targeted therapies for acute myeloid leukemia (AML) in older patients.
Historically, the standard treatment for AML has been intensive chemotherapy, which can be difficult to tolerate for patients who are age 60 and older.
To address this unmet urgent medical need, the LLS is conducting the Phase 1b/2 Beat AML trial (NCT03013998), which uses genetic screening technology to identify the genetic mutations or markers that may be driving AML in individual patients.
Depending on their cancer’s genetic profile, patients are matched to the most promising targeted investigational therapy, or combination treatment. If an individual does not have a genetic marker that matches a specific treatment, that patient will receive a broad-acting therapy.
The mode and length of treatment will depend on the therapy assigned to each person.
One of the trial’s main goals is to evaluate the patients’ clinical response rates to their assigned therapy, which is defined as either a complete or partial response. A complete response occurs when the leukemia is put in full remission, with bone marrow and blood cell counts returning to normal.
The trial is enrolling up to 2,000 AML patients, 6o years old or older, across multiple centers in the U.S. More location and contact information and can be found here.
Protocol First holds an eClinical platform that allows Beat AML staff to access information and record trial data. The company also developed an application, called Clinical Pipe, that ensures the real-time transfer of electronic health records from participants in the Beat AML trial into a research database, also called an electronic data capture system.
These technology solutions are cloud-based. They have allowed most of the clinical trial’s activities to be performed online for nearly four years.
“We have been working with the Protocol First team since we launched our Beat AML Master Clinical Trial program in 2016,” Amy Burd, PhD, LLS vice president of research strategy and the organization’s lead for the Beat AML initiative, said in a press release.
“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,” Burd said.
Protocol First’s tools also allow for trial sponsors to verify clinical trial data from multiple centers without being on-site. The researchers said Clinical Pipe has helped decrease errors and reduce the amount of time needed to enter data manually. That has enabled the prioritization of higher value-added tasks in the trial.
“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.
“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 added.