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Case Studies
BEARDSWORTH partnered with a mid-sized pharmaceutical corporation to complete a multi-trial program in the development of a treatment for severe xerostomia or ‘dry mouth’ – a consequence of radiation therapy in the treatment of head and neck cancer. Two pivotal studies were simultaneously conducted. A total of 90 study centers were opened to enrollment. BEARDSWORTH identified Principal Investigators who were radiation oncologists and dentists affiliated with large cancer centers. A total of 570 subjects were enrolled – ON TIME – within 24 months of the investigators’ meeting! The studies required that 1068 site visits be conducted over the nearly three year duration of the conduct of these trials. QoL assessments were required. Subject-completed Visual Analog Scale (VAS) measurements were key efficacy measures. More than 34,000 CRF pages were double-key entered and reviewed. The overall query rate was better than 1 in 10 pages. The database audit revealed an error rate of only 0.03%. Given the excellent track record of these two pivotal trials, the sponsor turned to BEARDSWORTH again to conduct their next trial in palliative care of cancer patients.
Case Study #2: BEARDSWORTH delivers patient cohorts on time in Phase I trials in advanced cancer patients
Success in conducting Phase I studies in advanced cancer patients means enrolling appropriate subject cohorts on time, quickly assessing safety parameters, and continuous and frequent monitoring of the highest level. A Phase I, dose escalation trial of DRUG X in patients with unresectable, relapsed or refractory advanced solid tumors for whom there was no curative therapy was conducted over 10 months (contract to clinical trial report) under the leadership of a single PI with a central and four satellite offices. The population enrolled included subjects diagnosed as having: colorectal, renal, rectal, NSCLC, ovarian, pancreatic, gastric, and breast tumors. Two regionally-based monitors (based within driving distance to all site offices), a medical monitor, and a NJ-based project manager served the trials clinical needs. To ensure all study procedures were followed in this very complicated trial and to thoroughly assess safety, 30 on-site interim monitoring visits were made by the monitors or the project manager during the course of the trial. Monitoring visits were timed such that a monitor was on-site for the first patient’s dosing at each office at each dosage level. Protocol design required a careful opening and closing of enrollment cohorts to ensure that subjects were not exposed to a higher dosage level before the prior level was deemed to be safe. Continuous communication between BEARDSWORTH team members and the offices conducting the trial resulted in the enrollment of this trial to be completed in the absolute minimum number of days possible while not violating the protocol. We delivered appropriate subjects on time every time (4 cohorts in 16 weeks), as dosage levels were evaluated to determine the maximum tolerated dose (MTD). Trial personnel were consistent from project start to stop and BEARDSWORTH completed the data management and medical writing portions of the project in a timely manner. Together, BEARDSWORTH and the SPONSOR, moved on to Phase II.
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