By William Tobia M.S., M.B.A.
Editors note: We are excited that Mr. Tobia has decided to begin contributing to iMedicalApps, bringing his wealth of experience in clinical research from both the academic medicine perspective as well as the pharmaceutical industry perspective. He will be looking at the impact of mobile technology, particularly mobile apps, on clinical research.
The end-of-year holidays are meant to provide all of us with some well deserved “R and R”. But now that we are well on our way into the new year, those involved in clinical research are still dealing with “R and R”, namely recruitment and retention of patients.
According to a recent report from Cutting Edge Information, “Clinical trial costs are skyrocketing amidst patient shortages ….. At the same time, companies face stringent demands for more safety data – and patient recruitment stands as a pivotal roadblock.” From an industry perspective, there is no “quick fix” to this challenge.
However, at the very least, what will help is getting accurate information in the hands of patients, in a format and content that is easy to use and easy to understand. One such app by CISCRP (The Center for Information and Study on Clinical Research Participation) attempts to do just this, and succeeds.
Simplicity of design is what makes this app so attractive. The format, design, color, and clarity make for a very unassuming visual experience – just what is needed for those suffering from disease, in search of information and hope. There are only four sections of information within this app: Answers, Resources, Search, and NewsWatch.
As shown here, the important elements that need to be considered by prospective patients are adequately addressed, in a simple “Question and Answers” format. For example, the question “How to evaluate whether a clinical trial is right for you” includes discussion on such standard items as clinical study phases, eligibility criteria, and evaluating the site staff. But this app goes beyond these expected items by having the patient consider additionally important factors, such as logistics – how often and at what time of day will my doctor visits be? How convenient is it for me to get to the doctor’s office for each visit?
The “Resources” section includes a Glossary of Terms, Medical Specialty Association Contact information, and CISCRP resources. The “Search” section offers assistance in finding local clinical trials of interest via telephone, web form, or through the CISCRP “Search Clinical Trials” website. And finally, the “NewsWatch” section links the user with the CISCRP “Medical Heroes” Newsletter webpage, where each of the quarterly issues can be accessed. Again, ease of use of this app allows the novice user to comfortably explore the many areas of valuable information.
Given the above, it was disappointing for this reviewer to note that much of the information is written at a level of comprehension that exceeds the very population that it is attempting to attract. For example, the “Eligibility to Participate” subsection equates to a 14.2 Flesch-Kincaid Grade Level. 45 CFR § 46.116 General requirements for informed consent states “… The information that is given to the subject or the representative shall be in language understandable to the subject or the representative….”. Interpretation of this requirement by the industry varies greatly, but is most often evidenced by a Flesch-Kincaid Grade Level that approaches only half this level, in other words a 7.
All things considered, this easy to use and free iPhone app delivers factual and useful information for those considering participation in a clinical trial. Subsequent releases should expand readability to the greater population.
Link to “A Guide to Clinical Trials” app on iTunes: http://itunes.apple.com/us/app/a-guide-to-clinical-trials/id365106014?mt=8