Standardizing IRT implementation and management is important to moving forward with clinical trials. IRT, or interactive response technologies, is also very important in increasing the efficiency and decreasing the cost of clinical trials and applications. While there is no perfect, foolproof method of standardizing IRT, there are options that are more likely to be successful for the majority of applications.
Common Challenges to IRT Implementation
With any new implementation or change surrounding clinical trials, there are challenges to be addressed. The most common challenges seen with the implementation of IRT include:
- Changing over from or merging with older technologies
- User acceptance of the IRT (web-based) versus IVR (phone based) technology
- Ensuring compliance during any change-over period
- Keeping training plans updated as technology changes
Those who have been handling clinical trials without the newest in IRT options are finding they have become complacent. There is some resistance to embracing IRT, and that resistance may be the biggest challenge faced by the new system. Fortunately, there are many ways IRT can be highly beneficial, and there are solutions for the challenges as they relate to implementation.
Solutions to Common Challenges
Changing over from IVR to IRT is really not complicated, but there is still some resistance to using the web-based option. Those who prefer phone-based choices often do so because of lost passwords or because they find making a phone call more convenient in certain circumstances. This is understandable, but there are fewer situations each day where IVR would be encouraged or even necessary.
The rapid pace of IRT configuration and development makes merging with older technologies much easier. It is also relatively quick to change over to IRT instead of attempting to merge different methods or options. As users see the ease with which IRT can be adapted for nearly any scenario, they will offer less resistance to the new technology. Compliance is also easier than ever with IRT, because it integrates with EDC systems and provides IRB date capture. With IRT, it's more difficult to make mistakes that could lead to noncompliance issues.
The Value of IRT
Many advantages can be seen with IRT. For example, it's possible to set up study protocols much faster. These can be tested and deployed at a more rapid pace, making it easier to move onto clinical trials. Every clinical trial is important, because it has the opportunity to provide a lifesaving medication or device to people in need. Without conducting these trials properly, a lot of the value could be lost. They could even put the public at risk.
By using IRT, it is easier to log and study responses, and easier to keep important information together so it can be analyzed and used correctly. Interactive responses also lower the opportunity to make mistakes, because there's more confirmation of the information being collected and analyzed.
Strategies for Standardizing the Process
In order for IRT to become globally used and trusted, the process for using it must be standardized as much as possible. Strategies for doing this include:
- Drug supply ordering and tracking must be automated, which will help cut down on the number of people needed and the hours they will have to work.
- Adaptive trial designs will have to be accommodated, which means flexibility of IRT will be needed.
- The phone-based and web-based options must be multi-lingual, in order to make global trials easier to create and more successful. This will reduce the chance of errors based on a language barrier.
- Study staff should be notified en masse of any warnings or milestones in order to ensure everyone involved with the study understands all that is taking place.
- Project managers who understand IRT will be needed in order to address questions and concerns throughout any clinical trials.
- Web reporting must be in real time, as this will help avoid problems with a lack of medications and other clinical trial necessities.
With a more standardized process, IRT implementation can go a very long way toward providing success in global clinical trials. That will have a beneficial effect for a significant number of patients.
(Image courtesy of Kamal Hamid via Flickr)