Health care system:
Interactive Response Technology (IRIT) describes a set of computer-programmed systems in which people (or groups of people) can rapidly make direct subjective observations about health-related occurrences, in real time. The system is controlled by a clinician or other health care professional who can program the system with specific details about the health event being observed, such as the participant’s age, gender, illness status, symptom category, vital sign level, imaging data, and so forth.
Once the system is set up, real-time images are displayed on screen and reports are generated automatically. The reports can be presented either to individuals within the research study itself or to a central repository of data, which may include multiple health institutions or research centers.
Although clinical trials generally have a good track record of meeting established protocol and the standards of the FDA, sometimes errors do occur. Improper information or misinterpretations may result in the missing or late submission of data to the regulatory agency.
In order to avoid these delays, researchers are exploring the use of interactive response technology to address some of these issues. If this technology is ever widely adopted by clinical teams, it could provide significant benefits in reducing delays in obtaining needed data and in enhancing quality control.
Clinical trial and electronic data manage:
One example of how electronic data management might work is during a clinical trial. Usually there is a primary and secondary participating site, and every data collector is assigned to one of the sites. During the course of a trial, it is usual for at least one site to experience a data loss, usually related to an accident or other issue unrelated to the study. This incident is documented, and then referred to the trial sponsor.
However, even if the incident is not reported at the time of reporting, it can still occur later, especially if the site that receives the report is located far from the site that was originally supposed to receive the data. In cases like this, a new site must be selected, and the sponsors will often request the trial data records from the original site in order to ensure that the new site is functional.
Interactive technology:
The use of interactive response technology can also improve the accuracy of clinical trials. During a trial, both the investigator and the medical professionals responsible for a particular treatment may collaborate through different computers, sending and receiving information through a single connection. If all of the parties involved in the study work together in this way, the chances of error and misinterpretation are greatly reduced.
Importance of FDA:
The same technology can also simplify the paperwork involved with the regulatory approval process. The information necessary for obtaining OTC-approved indications and for filling out the clinical trials is available in a “packset.” By using a pre-determined set of prompts, the information on each patient can be submitted to the FDA with minimal effort. This convenience and efficiency allows the agency to approve the medication before the medication makes it to the marketplace, improving access to R&D opportunities for the pharmaceutical industry.
The FDA itself is taking advantage of the technology. Recently, the agency issued a final rule encouraging pharma consulting firms and companies to provide visual electronic prompts for clinical trials. The FDA wants to see an electronic version of the prescription so that the prescribing doctor can easily identify how to prescribe based on the patient’s responses. Also important is the fact that these prompts will help reduce errors in filling out the forms. This can ultimately lead to higher levels of patient satisfaction.
Usage of FDA:
There are several ways that the FDA is using the technology to make the process more efficient and less time-consuming. For example, some clinical trial sites are installing interactive technology that allows the supervising physician to manually select the appropriate patient demographics and set parameters for the study. Also, instead of having the patient complete the entire checklist.
The monitor can automatically email or send the completed form to the appropriate person. These electronic systems allow researchers to see the results quickly and determine if additional research is necessary. Efficacy studies have shown that patients completing the checklist and using these methods has increased the compliance rate by as much as 48 percent.
Another way that the FDA is utilizing the benefits of interactive response is in the design of the actual study itself. Instead of simply collecting information about the response of the patient to the treatment, researchers now collect demographic information as well. This information is used to allocate a certain portion of the allocation funds to each demographic.
Which allows the researchers to better analyze the effectiveness of the treatment. This is especially important in the case of treatments for serious diseases like cancer where analyzing data from multiple groups can help lead to better development of the drug.
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