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Interspond’s RxPaging, Scientific Software Tools, Inc.’s VISTA, and Jurilab’s DrugMEt.
Interspond (Madison, WI) turned to an existing technology to remind subjects to stay compliant with their medication. It used the pager, which originally was used because cell phones were too costly and bulky for carrying.
Trial subjects, Interspond believes, want to be compliant. They just forget: human subjects are human, after all. Remind then to swallow a pill and record any adverse events, and they'll be dependable. The 1.5-way pager is nothing more than a portable instant-messenger window, which Interspond "IMs" at each subject's specific compliance times. They respond by choosing "took it," "taking it," "will take soon" or "can't take it."
The pager a subject is given at the trial site goes off twice, so subjects know what to expect. Once the subject is home, Interspond pages them whenever the study protocol demands it: time to take a pill, or conduct a reading, or begin a new diary. If subjects leave the beeper at home, the lack of response will be noted as noncompliance. Subjects who want to be compliant but can never remember have gentle nudges to help them along.
The site receives weekly statistics of response rates, which can be matched up to compliance figures from diaries.
Interspond, (608) 661-8842,www.interspond.com
Scientific Software Tools, Inc.
(Media, PA) knows that the compliance of subjects who take their doses on time is crucial for a study. An even more crucial type of compliance is the compliance of the individual sites for trial sites considering a switch to EDC. It takes hardware and software requirements for such compliance, though, not just positive attitudes and a willingness to learn.
With that in mind, it created VISTAâ¢, the Verifiable Investigative Site Technology Assessment. VISTA can determine the existing computer hardware and software at a site, by running an audit of each computer's features. It's simple enough for anyone to run in minutes, and it produces results quicker, cheaper, and often more accurately than a phone or paper-based assessment survey. Doing so will give trial site personnel an accurate view of what each site has and what it doesn't, helping determine how much an EDC switch would truly cost.
A good EDC product will save money and time, and produce better results than paper. Making sure the implementation of the EDC system goes smoothly could be a more important decision than the choice of an EDC system itself.
Scientific Software Tools, Inc., (601) 891-1640, www.sstnet.com
(Kuopio, Finland) is not the first company to delve into pharmacogenetics, but it is one of the first to come up with a PG service for the clinical trial world.
DrugMEt is a microarray-based genetic test that searches eight different genes for drug metabolizing enzymes. If a subject has too many or too few of them present, they could be at a higher risk for an adverse event, end up being nonrespondent to the study drug.
No two people will react to a chemical in the exact same way. By eliminating the extreme ends of the bell curve of efficacy, DrugMEt can help trial sites focus their energy on the majority of the patient population who can safely use the study drug, not the adverse event cases.
Jurilab was able to develop this due to its extensive research into the East Finland Founder Population, a genetically homogeneous population.
One day, tests such as Jurilab's will be as commonplace as a blood pressure reading or an alcohol swab. For the present, the brave volunteers of clinical trials get to have them first.
Jur0ilab, 4358 17 467 8000, www.jurilab.com