February 10, 2016
YPrime, Inc., a clinical trial software products and services company; ProPhase, LLC, a global provider of measurement expertise in clinical trials; and DupCheck, a global provider of duplicate enrollment checking across clinical trials and sponsors, have announced integration of DupCheck into a tablet-based platform for capturing clinical trial data with advanced data analytics to improve endpoints and study results. This seamless integration will provide an automatic check for duplicate or recent enrollment across studies, sponsors, and indications, without the need for entering data into multiple systems. This will improve the quality of studies while reducing site burden and study costs.
In their announcement, the chief executive officers of the aforementioned companies underscored the opportunities this partnership offers: by increasing the feasibility of universally-performing duplicate checking with no additional burden to research sites, the clinical trial process will be enhanced significantly.
“Enrollment of subjects in more than one study at a time, or during the washout period after a previous study, can lead to failed or negative studies, bias study results, and endanger the safety of study participants,” said Jonathan Rabinowitz, PhD, Founding Director at DupCheck.
The first clinical trial to use the integrated solution is scheduled to begin recruiting subjects next month.
“We are changing the science of clinical trial development by providing intuitive and insightful software that captures and uses traditional data more effectively by providing additional vital functionality like DupCheck,” said Shawn Blackburn, Chief Executive Officer at YPrime. Sofija Jovic, PhD, MBA, Chief Executive Officer at ProPhase noted that “the drug development process remains vulnerable to imperfect measurement of outcomes that inflate costs and create delays. This collaboration combines our company’s deep expertise in measurement science with YPrime clinical trial software and DupCheck functionality, to create digital platforms that provide sites and sponsors with access to real-time, actionable data to power better outcomes.”
“Our collaboration is designed to improve the safety and validity of clinical trials by including duplicate checking without burdening research sites. By integrating DupCheck functionality into a required system like IRT or ePRO, studies no longer have to enter data into yet another system. This reduces study costs and site burden. Duplicate enrollment is a universal exclusion criterion. It can result in misattributed safety signals, dangerous drug interactions, bias efficacy results, and reflects on quality of research subjects,” said Rabinowitz.
DupCheck is a web-based tool used globally to screen for duplicate patients in clinical trials across studies, sponsors and therapeutic areas. Duplicate enrollment harms both patients and studies. In many therapeutic areas even a small number of duplicate patients can lead to a negative or failed trial. In addition enrolling duplicate patients can result in a misattributed serious adverse event.
DupCheck is a tool developed as part of IMI/EFPIA NEWMEDS, an international consortium of scientists that has launched one of the largest ever research academic-industry collaboration projects. NEWMEDS brings together top scientists from academic institutions and nearly all major biopharmaceutical companies to develop new approaches for shorter and more efficient trials of new medications.
DupCheck provides sites and sponsors with real time information on attempted duplicate enrollment at time of screening. DupCheck can also screen for previous participation in a trial of investigational drug