28.Sep.2012

OCT will perform feasibility and qualification visits for two phase III studies in pain

One of our return clients referred to OCT to perform feasibility and site selection visits for their two phase lll studies in pain

One of our return clients referred to OCT to perform feasibility and site selection visits for their two phase lll studies in pain. The sponsor is a large German pharmaceutical company with their own clinical team here in Russia. When feasibility assessments are not conducted thoroughly, consistently, and in a systematic manner, this may result with enrollment delays and significant increase in cost. Keeping these potential problems in mind and not having enough experienced resources to perform high-quality feasibility and site selection visits, the Sponsor has decided to outsource that important part of both trials to OCT.

Site-level feasibility assessments should focus on whether the protocol is a good fit for a particular investigative site to conduct. For a given site, there must be investigator interest, an accessible patient population, suitable capabilities, and available resources when the study is to be conducted. Before study start-up OCT will conduct final study feasibility on the basis of a final Protocol. We will select the sites most suitable for the studies based on criteria including:

  • Sites with relevant past experience and performance;
  • Telephone and / or questionnaire screening of potential Investigators to ascertain interest;
  • Checks with relevant regulatory bodies for disqualified/debarment lists;
  • CDA obtained from potential sites by OCT before study-specific information is supplied;
  • Any sites identified with issues would be reviewed by Sponsor and removed from the list as appropriate.

    Upon the list of sites approval OCT will conduct site selection visits. OCT will perform 15 site qualification visits for the study evaluating the analgesic efficacy of the opioid agents combination on moderate to severe pain after an abdominal hysterectomy. Another study evaluating efficacy of an opioid agent in patients with moderate to severe acute pain after a total hip arthroplasty will require 15 site selection visits.

    OCT is happy to offer study feasibility services to our clients. We have our own database of medical institutions specializing in various therapeutics areas in Russia, Ukraine, Belarus, Latvia, Lithuania, Estonia, Bulgaria, Poland and Czech Republic.