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Oncology Trials, with frequent dosing modifications, variable cycle quantities, and other unpredictable factors, can pose unique challenges to the work of Clinical Trial Managers (CTM) and Clinical Supply Managers (CSM). A flexible Interactive Response Technology/Interactive Web Response System (IRT/IWRS) can assist in the management of these complex trials. This post will highlight some of the challenges and design elements that must be considered when implementing an IRT/IWRS that can address these nuances.
Trials using adaptive design have been an area of continued interest for the clinical trial industry due to the promise of improved efficiency and mitigated risk of failure in the clinical research process. With increased industry pressures to reduce both the cost and time it takes to bring a new drug to market, the prospect of leveraging adaptive trial designs to identify both successes and failures earlier in the trial process and making adjustments to a study design based on analysis of data collected is attractive to many companies, but also introduces challenges that need to be overcome.
There's a lot going on in the clinical trial and IRT/IWRS arena these days. New trends are appearing left and right, from basket studies, to increased transparency, to a soaring reliance on big data. How is anyone supposed to keep up with it all?
Luckily, there are several major clinical trial events each year where anyone interested in the space can get their extra dose (no pun intended) of knowledge. To make life easier, we've compiled a roundup of some of the most important upcoming events here, along with why you should attend and how you can get more info.
- September 16-17: ISPE's European Investigational Products Conference
- October 20-22: Global Clinical Supplies Group European Annual Conference
- October 26-27: CBI IRT Conference
- November 8-11: ISPE Annual Meeting
The Quality and Compliance department has many critical roles at a company that creates IRT/IWRS systems in the pharmaceutical/biotech industry—namely to ensure regulations are met and to put a robust quality management system, including appropriate Standard Operating Procedures (SOPs), in place and ensure it is followed. There is, however, an often-overlooked responsibility that Quality and Compliance has, especially in a company providing clinical trial software—and that is enabling innovation.
An often under-valued aspect of Interactive Response Technology or Interactive Web Response Systems (IRT/IWRS) is their ad-hoc reporting capabilities. These systems contain large amounts of important clinical trial data, most of which is becoming increasingly valuable in the day-to-day decision-making of Clinical Trial Managers (CTMs) and Clinical Supply Managers (CSMs). By utilizing direct access to study data in an IRT/IWRS through comprehensive real-time ad-hoc reporting, CTMs and CSMs can make more informed decisions regarding patient treatment, study milestones, and drug-supply, and without the expensive costs of change orders for custom reports.