Managing Oncology Trials
Oncology Trials, with frequent modifications in doses, several cycle quantities, and other unpredictable factors, continue to pose unique challenges to the work of Clinical Trial Managers or CTM and Clinical Supply Managers or CSM. A flexible IRT/IWRS (Interactive Response Technology/Interactive Web Response System) can offer help in the management of these complex trials.
How to Manage Drug Supply with an Uncertain End of Study Treatment
Unlike other clinical trials which has a fixed duration, oncology trials are often designed to adjust trial duration based on the individual subject’s response as well as overall results across the trial. When selecting an IRT/IWRS service provider, watch for a flexible IWRS/IRT system that can expand the visits for subjects that are eligible for continuous treatment.
By expanding the visit schedule for only those subjects that reaches the end of their present visit schedule, study-wide drug projections are not altered when a single subject reaches the expansion point. This confirms that drug configurations can remain consistent throughout a trial, requiring less intervention whenever a subject’s schedule expands.
Unknown Start and End Dates of Cycles
In situations where treatment cycles might begin earlier or later than expected, an IRT/IWRS with a rigid or static visit routine cannot accommodate shifting visit dates.
Inculcating a system capable of re-projecting a subject’s entire visit schedule after the beginning of each cycle, can address this challenge of scheduling. As subjects might not always come in for their scheduled visit on the expected day for various reasons, like adverse events or personal conflicts, ensure your IRT/IWRS can project future visits based on past ones.
Unscheduled Visits and Dose Withholding
When there is a situation when a subject is not ready to receive their next dose, unscheduled visit and dose withholding capabilities permit you to manage these exceptions in a safe manner.
Dose withholding is created to handle subject safety during the administration of experimental study drugs. This is crucial in oncology clinical trials as subjects are in those situations that could render them sensitive to some treatments.
Dose Modifications in Cycled Visit Schedules
There is a mild balance between changing a patient’s dose to suit their personal needs and managing the clinical trial successfully per the protocol. An IRT/IWRS having the ability to adjust doses based on subject safety and tolerance per the protocol confirms the maximum and minimal dose levels.
To conclude, tracking subject doses might be problematic in oncology clinical trials that consist of various dosing options.
Conclusion: Look into these Challenges
Selecting an IRT/IWRS which is robust enough to handle the unique challenges of oncology trials can help CTMs and CSMs well manage the unexpected. The IRT/IWRS must be able to manage drug supplies with a several study treatment, unknown beginning and end dates of visiting cycles, unscheduled visits and dose withholding, as well as modification of dose in cycled routine visits.
We conclude here.
Among several good organizations, CRB Tech Solutions created a good name for itself. We offer good clinical practice training. CRB Tech has earned the name of one of the best training institute in Pune.
It has earned a good name for itself among the institute of clinical research in Pune, who offers best training in Clinical Research courses.
Clinical research jobs in Pune are increasing and to meet the current demand of proficient candidates. For your own career oriented goals, you should join institutes with good clinical research training program.
If you are trying to find clinical research courses in Pune, CRB Tech Solutions is one step ahead from your success.
The Clinical Research review by CRB Tech Solutions is sufficient to make you move ahead in a career in this field