Feature Article

Last week there were 2 press releases that should be of interest to anyone participating in clinical research. First the Audit Bureau of Circulations reported that newspaper circulations were down 2.5% to 5% depending on the geographical areas. Many sited the Internet as the reason for the decline.

Obviously the Internet is becoming the preferred medium choice when looking for information. Not surprising given that we can read all major newspapers online without ever taking them to the recycling bin or getting ink on our hands.

The second press release of interest was from the FDA.

FDA Press Release, May 3, 2007

“FDA Launches New Web Page, E-newsletter to Enhance Online Consumer Health Information”

This press release indicates that even the federal government recognizes the need to reach out and educate patients electronically. To read the complete press release click here: http://www.fda.gov/bbs/topics/NEWS/2007/NEW01627.html

These 2 news items are of little impact individually to the research practice, but when put together and viewed with an eye towards clinical research and our recruitment efforts it becomes quite interesting.

Have we stopped to think of the potential we may have at our own fingertips if we initiated a service that paralleled the FDA’s patient information? Imagine, how much easier recruiting subjects would be, if we used our websites to promote clinical research in positive ways, with additional links to sites like the FDA or to the sponsors. Let’s say our website has a podcast explaining the benefits of any new FDA approved drug or treatment that pertains to our practice, what impact could that have on our practice, and our research efforts? Simply referring patients and their families to our website would give us exposure 24/7 and place us, and our offices in the limelight of information delivery and cutting edge research.

Many years ago most physicians believed that advertising wasn’t ethical and many shied away from it with little more than an ad in the local telephone book. But times are changing and if we want to capitalize our efforts we have to reach out to potential patients and clinical research subjects in the mediums they want. To me this isn’t advertising, it’s educating. An educated patient can become an excellent research subject, especially if our websites provide more than just our location and hours. Although this is a great start, it’s not enough when people are flocking to the Internet to search out the information they want. The more information our websites contain about our research efforts the more information we are extending to our potential subjects.

So how would you rate your website presence?

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Study Coordinator Basic Training A-Z - This is a comprehensive introduction to Clinical Research for Allied Health Personnel. The foundational preparation required for the role of Clinical Research Coordinator will be provided. Course manual and other materials helpful to the study coordinator will be provided.

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Soliciting Clinical Trials – This 2 week class provides answers to your most asked question of 2006.

“Can you help us get trials to our site?” Well yes we can! In this class you’ll not only learn the many ways to achieve this but also learn the steps that will position your site to be well received by sponsors.

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	Glossary Exploration

Each month we’ll help expand your clinical research understanding by exploring the terms and acronyms that we function with everyday. Seems simple right? But, there are so many things that we don’t know and others that we need to know better.

“People do the best with what they know – when they know better they do better!”
- Maya Angelou

ACTION LETTER: An official communication from FDA to an NDA sponsor announcing an agency decision. See approval letter, approvable letter, not-approvable letter

BLINDING/MASKING: A procedure in which one or more parties to the trial are kept unaware of the treatment assignment(s). Single-blinding usually refers to the subject( s) being unaware, and double-blinding usually refers to the subject(s), investigator( s), monitor, and, in some cases, data analyst(s) being unaware of the treatment assignment(s).

CIRCADIAN RHYTHM: Biological timing and rhythmicity that, in human beings, is characterized by cycles of approximately 24 hours. Synonym: biological clock

ELECTRONIC SIGNATURE: FDA elelctronic signature means a computer data compliation of any symbol or series of symbols executed, adopted, or authorized by an individual to be the legally binding equivalent of the individual’s handwritten signature.

INDEMNIFICATION: A legal document indicating protection or exemption from liability for compensation or damages from a third party; usually protects an investigator and/or hospital or institution from claims made by the study subject (or relatives) that harm was caused to the subject as a result of participation in the clinical trial.

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