Phase 1 study require daily monitoring. This population of patients can have rapid changes in the course of their disease or response to therapy. Frequent communication between investigators and patients as well as investigators and the sponsor is critical for maintaining patient safety in case toxicities arise.
CRAs must monitor screening and enrollment at each site. They also need to have frequent contact with sites to make sure data are logged in a timely manner.
Electronic data capture can facilitate quality control of data and dissemination of data to the sponsor, investigators, and safety boards; monitoring for protocol compliance; and recognizing trends in toxicity. Having a sophisticated technology platform can be used for quickly updating, obtaining, and reacting to information so individual parties can communicate and interact with each other without complicated exchanges of data.
Being able to assess reliability of data is a significant advantage of electronic data capture. Data can either be monitored manually, or comparison functions can be automatically programmed to check, for example, whether data fits with inclusion/exclusion criteria specified in the protocol. Having access to data provides an immediate chance to correct or clarify uncertain data points.
If you want to learn more about how developing a solid trial design, integration technology and selecting high-performing sites and personnel can help streamline the conduct of your Phase 1 oncology trial and improve the quality of your trial data, download a copy of our whitepaper entitled, “Ensuring Success in Early Phase Oncology Clinical Trials,” at http://bit.ly/NyzYzl.