inVentiv Clinical Trial Recruitment Solutions (iCTRS), an inVentiv Health company helping the biopharmaceutical sector reduce time to the start of clinical trials, has announced that the process innovations offered by its partnership with ViS could cut in half the time required to conduct feasibility studies.
The most recent report issued by the Tufts Center for the Study of Drug Development (Tufts CSDD) said the drug development model had not fundamentally changed in years, and the future success of pharmaceutical companies will depend in part on their ability to adopt greater efficiencies and best practices.
One area ripe for improvement is clinical site feasibility in planning for a trial. Even though the selection of sites capable of enrolling patients is a critical step to ensuring the smooth operation of a clinical trial, site selection is fraught with inefficiencies. An estimated $10 billion a year is wasted because of poor site selection.
The use of technology is critical to process improvement in feasibility. To demonstrate the potential for savings, iCTRS took data from 100 feasibility studies conducted by inVentiv and analyzed the time required to perform each of the individual tasks involved in such studies. The company then looked at how much time the application of ViS technology could save for each task. Cumulatively, the efficiencies offered by ViS cut the total feasibility study hours by 54%, while delivering better quality. Additional time savings potentially could be realized by applying other technologies in the iCTRS portfolio.
ViS Research, creator of a comprehensive online feasibility platform, gives trial planners better, real-time data for the efficient evaluations of locations, sites, investigators and networks for possible inclusion in clinical trials. The ViS global map of clinical research infrastructure, assembled over a decade of research, includes detailed and vetted information on more than 400,000 disease-specific centers.
Research centers and investigators can efficiently share their capabilities by uploading a profile on the digital platform where the information can be stored and updated regularly, eliminating redundant paper questionnaires. Up until now, many investigators chose to not participate in feasibility because it was so difficult. Instead of answering the same questions multiple times, investigators can now build upon the existing profile and focus on answering protocol-specific questions that will help differentiate their site from another site being considered.
For trial sponsors, the ViS profile provides answers to 85% of the routine questions they normally ask. Sponsors can review the profiles and use the platform to contact investigators and gather additional information. High-quality analytics and visualization tools allow sponsors to quickly and easily compare sites and feasibility data for accelerated selection of sites that are properly equipped, staffed and ready to be activated for study participation.
"At the end of the day, this is all about doing feasibility studies better, faster and getting drugs and devices into quality clinical trials at an accelerated rate," said Ramita Tandon, senior vice president and general manager for iCTRS. "In the next phase of development on the ViS platform, we'll accelerate processes even more."
iCTRS has launched its own proprietary network on the ViS platform, using the social media functions that enable easier networking. iCTRS is the only service provider with rights to use the ViS database for building its own social network. Investigators will have access to information on new trial opportunities posted by iCTRS, while sponsors can share information on upcoming trials and more closely interact and collaborate with investigators.
iCTRS and ViS are developing additional, exclusive functionality, including automating the workflow process for confidential disclosure agreements (CDA) and the onboarding of clinical trial investigators. Streamlining and simplifying processes will help attract and retain investigators who can enroll patients, conduct efficient trials and move the start-up phases into the 21st century.
iCTRS was specifically created to integrate a game-changing set of global capabilities to accelerate trials in a predictable and cost-efficient way. "It's all about hitting timelines, and it starts with feasibility. This is the first place we challenge assumptions about old ways of doing trials and find efficiencies through technology to do things better," said Tandon.