Mark Kosinski
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What's worse than spending millions of dollars on a clinical trial only to discover your findings are wrong? Learning too
late that those errors could have been prevented. Health survey administration errors, data entry mistakes, and mathematical
miscues are just a few of the common missteps during clinical trials that have cost companies millions and delayed the introduction
of new drugs. In one well-known population study, for example, the first question of the survey was inadvertently left off
when the questionnaires were reprinted.
In another case, the questionnaire responses in a large clinical trial were mislabeled, leading to significant errors in scoring.
Also, too often, companies try to write their own survey scoring programs.
Even companies with experience and expertise find the task of coding and reproducing scoring algorithms extremely challenging.
With so much depending on accurate data, taking such a do-it-yourself approach can be very risky.
What it meansWhen data and scoring errors occur, the impact can be far reaching. You could miss out on a huge opportunity if bad data masks
a benefit of your drug that could open up a new, unexpected market.
Fortunately, there are tools available that can help protect the time and money that you invest in health surveys.
Software exists that standardizes the scoring and processing of data and tests for data entry and coding errors. This software
can simplify the process and provide reliable results you can trust.
Since the quality of your data is so important to your success, look for a scoring solution that can evaluate data quality
and alert you to any data problems that exist.
Since humans are administering and completing the surveys, there are a number of things that can go wrong during the survey
process. Questions can be skipped or answered incorrectly. The survey might be administered improperly or survey responses
could be keyed into a database incorrectly. Make sure the scoring software you eventually choose can recognize these types
of problems so that they do not corrupt your results.
When a partially completed survey is discovered, some of today's scoring programs can actually help fill in the blanks. Before
you purchase your scoring software, find out if it includes this feature. If so, you may be able to save substantial time
and money in the long run.
Other considerations
When deciding on a scoring solution, ask yourself whether you want to install and run the software at your company or if you
want a patient reported outcome (PRO) expert to handle it for you. This person can help interpret your data as well.
If you decide to go the PRO route and you want the convenience of submitting your data on the Web, choose a scoring solution
that offers that option.
On the other hand, if you have data privacy and security concerns and you want to score your data within the confines of your
own software system, make sure the scoring software you're thinking about purchasing can be easily integrated into your own
system.
Health surveys provide invaluable insight and information throughout the clinical trial continuum. Therefore, be sure the
information you collect tells the right story. This is achieved by making wise choices about how you are going to score and
analyze your data.
Mark Kosinski, MA Vice President and Senior Scientist QualityMetric Incorporated mkosinski@qualitymetric.com
