This recent clinical trial successfully addressed some of the key concerns we hear from our customers when they are planning their clinical trials.
We wanted to tell you more about what made this study a success so you can see how we will handle your next challenge.
Your Top 3 Challenges: We’ve conquered them all!
Challenge #1: Dispense correct CTM and maintain adequate, but not excessive supply
Solution: Automated real-time electronic dispensation and resupply management
The Clinical Trial Material drug was in short supply and the sponsor was unable to stock sites with an overabundance of drug for each potential subject at each active site. To ensure adequate supply for dispensation, sites were initially stocked with a minimum supply for newly activated subjects. Each subject drug dispensation visit triggered an automatic dispensation of the correct treatment group bottle found in the site’s inventory, and also triggered an automatic resupply request for the next same treatment group bottle from the central depot. That requested bottle was not specifically assigned to that subject, but was stocked at the site for the next dispensation visit for any subject who had been assigned the same treatment group. Resupply requests were grouped daily so that depot could ship all medication in one package requested for that site.
The Result: Our systems alerted applicable study personnel and study systems with the instruction needed according to protocol requirements for each patient visit, including dosing information, shipping information and frequency. Sites were provided with the exact materials they needed, when they needed them – avoiding clinical trial material waste throughout the study.
Challenge #2: Collect the most accurate survey information directly from subjects efficiently
Solution: Migrate validated paper surveys to verified electronic (IVR or IWR) modalities
Subjects filled out the Bristol Stool Scale survey daily, a clinically-validated paper survey used in gastroenterology studies, which collects date/time information, number rated symptoms, and ratings based on comparison to descriptive and pictorial scales. We duplicated the same survey on our IVR phone system. All subjects completed both surveys whenever they contacted the system, with 50% completing the paper version first, and phone second, and reversed for the other 50%. Statistical analysis was performed to evaluate the correlation of the data, and also the compliance level of survey completion.
The Result: Subjects were 95% compliant in successfully completing both surveys, and the paper and IVR phone diaries showed that there was statistically high correlation between the data entered into each. In addition, there was no difference between the paper-first or phone-first groups; it was concluded that it was appropriate to use IVRS as the primary ePRO data collection method.
Challenge #3: Reduce wasted time, costs, frustration
Solution: Automated alert, reporting and notification systems
The IWRS assigned individual bottles per the randomization/medication list scheme. The system ensured that the bottles were not being dispensed out of order, and it kept a tight control on both the drug and the subjects that were assigned to a specific treatment group. It successfully maintained an appropriate supply of drug at the sites for upcoming subject visits. Site personnel received automated alerts, confirmations and other notifications. The system was also built with a manual override with which CTM Management personnel were able to provide approval or changes for resupply, enabling them to have complete control over the automated systems.
The Result: The client reported back that their post-study financial analysis supported the conclusion that they saved thousands of dollars and many hours of time. In addition to saving money, our systems eliminated the frustration often experienced by study personnel. Our IVR phone system eliminated high maintenance paper-collected PRO survey data. Our IWR system was custom built to randomize subjects, dispense correct drug, and track and maintain inventory where needed, automatically, and to communicate with system-generated real-time alerts, notifications and reporting so that study managers could respond with informed action quickly.
Put your study in our hands and we will deliver cost-effective and timely results.