NEW YORK, Tuesday October 11, 2011
Caligor Rx will give a joint presentation with experts from PAREXEL International at the Clinical Trial Supply East Coast Conference in Philadelphia on strategies for planning, implementing and managing supply logistics for at-home clinical studies.
Joseph E. Safdie, Esq., Caligor Rx’s Vice President and Corporate Counsel, will discuss the logistical and regulatory issues related to providing clinical trial supplies directly to patients for home-based research studies. PAREXEL experts who provide centralized coordination of clinical trial supplies, central lab services, and ancillary supplies worldwide, will join Mr. Safdie in presenting ‘Home-based Clinical Trial Supply: A Compelling Option to Enhance Enrollment, Increase Retention and Lower Cost.’ The presentation will take place at 2:30 p.m. (ET) Wednesday, October 19, 2011 at the Hilton Philadelphia City Avenue hotel.
“There’s no question that electronic clinical trials present both opportunities and challenges,” Safdie said. “Sponsors must ensure that study medication and supplies are shipped properly to the patient, and that proper storage, documentation and return procedures are followed. While the logistics are certainly more complicated, advances in web technology allow sponsors to effectively enroll patients, monitor their progress and collect data online. For smaller Phase II, III and IV studies that do not involve complex enrollment criteria, at-home trials offer significant promise in terms of scalability, efficiency and cost-effectiveness.”
Statistics from The Center for Information and Study on Clinical Research Participation:
- Each day a drug is delayed from market, sponsors lose up to $8 million.
- The delays in patient recruitment for clinical trials account for an average of 4.6 months lost per trial. When calculated, this is an annual cumulative loss of 26 years, on average, for each company.
- 50% of clinical research sites enroll one or no patients in their studies.
- Recent studies show that enrollment rates have dropped from 75% in 2000 to 59% in 2006 and retention rates have fallen from 69% to 48% during the same period.
Clinical Trial Supply East Coast, which takes place Oct. 19-20, is designed for pharmaceutical executives responsible for clinical trial supply, logistics, operations, purchasing and procurement, materials, packaging, manufacturing, research and distribution.