J Cancer 2013; 4(6):464-467. doi:10.7150/jca.6626

Research Paper

Examining the Effect of Teleconferences on Oncology Phase 1 Trials

Alexandra Mckane1, Chao Sima2, Sharon Fleck1, Glen J. Weiss1,2,✉

1. Virginia G. Piper Cancer Center Clinical Trials at Scottsdale Healthcare, Scottsdale, AZ, USA;
2. The Translational Genomics Research Institute, Phoenix, AZ, USA.

Abstract

Objective: Phase 1 clinical trials are the first stage of clinical development of an investigational agent. Because the trials often take place at several geographically dispersed sites, safety teleconferences are held to update investigators and the drug sponsor on safety information and other pertinent business related to the trial conduct. Here we examine associations between the frequency of teleconferences and other clinical trial factors on trial conduct efficiency.

Methods: We examined Phase 1 clinical trials for patients with solid tumors opened for enrollment at a single, non-profit cancer center in Arizona (Center) that had completed at least three dose levels. The following information was included: safety teleconference frequency, whether or not the sponsor or contract research organization sent follow-up requests for updates on patient accrual, and safety outside of scheduled safety teleconferences. The dose escalation scheme, route of study drug administration and formulation type (e.g. oral targeted therapy or monoclonal antibody) was also included.

Results: Forty-nine Phase 1 studies were examined for inclusion. The majority of safety teleconferences were regularly scheduled (81.6%) with most taking place bi-weekly (46.9%). Additional solicitation for updates outside of scheduled safety teleconferences were requested during the conduct of 31 (63.3%) studies. None of the factors analyzed were significantly associated with accrual, subject dosing, and dose escalation.

Conclusion: We found that the frequency of teleconferences does not appear to expedite phase 1 study accrual, subject dosing, or dose escalation in the first 3 cohorts of a phase 1 clinical trial.

Keywords: Phase 1 clinical trials, teleconferences

This is an open access article distributed under the terms of the Creative Commons Attribution (CC BY-NC) License. See http://ivyspring.com/terms for full terms and conditions.
How to cite this article:
Mckane A, Sima C, Fleck S, Weiss GJ. Examining the Effect of Teleconferences on Oncology Phase 1 Trials. J Cancer 2013; 4(6):464-467. doi:10.7150/jca.6626. Available from http://www.jcancer.org/v04p0464.htm