A study by the Polish Myeloma Consortium (PMC) and the University of Chicago set new standards for blood cancer therapy, according to an acknowledgement at the American Society of Clinical Oncology (ASCO). The findings also underlined the importance of supporting noncommercial sponsors, according to contract research organization Clinscience, which managed the trial.
The ATLAS study compared two maintenance therapies in patients with multiple myeloma after receiving autologous stem cell transplant.
A total of 180 patients from Poland and the U.S. were enrolled in the study. The results—which were presented at the ASCO annual meeting in June—confirmed the advantage of the therapy proposed by the PMC of superior progression-free survival compared to the standard treatment, thus offering new perspectives to multiple myeloma patients.
Clinscience's contribution was to address specific trial challenges, notably PMC’s lack of experience as a trial sponsor. The CRO added that the noncommercial character of the trial added to the complexity.
Clinscience has been supporting non-commercial sponsors in the comprehensive organization and management of clinical trials for many years, by offering an end-to-end service.”
Alicja Mazurkiewicz, associate project director at Clinscience, explained that few of the trial sites in Poland had experience on noncommercial studies, which meant Clinscience had to help with issues like documentation preparation, study drug delivery and biological material logistics procedures.
"In 2016, when we started working on the project organization, non-commercial research in Poland accounted for only 3% of the total. It was numerous sites' first non-commercial study, so the contracting process required additional commitment and an individual approach to discussions with each one's executives,” Mazurkiewicz said.
“For the project, we created a dedicated model of a tripartite agreement. We met in person with representatives of the sites to clarify any doubts related to the non-commercial nature of the study,” she added. “As a result, the site contracting process has been efficient, with all sites selected for the study successfully initiated.”