• 2012 January
• 2011 February
• 2011 January
• 2010 November
• 2010 June
• 2010 April
• 2010 March
• 2010 February
• 2010 January
• 2009 December
• 2009 November

• See how we have strategically helped other clinical trials. Case Studies

• Follow Us

  

• Request a Proposal

Informed consent by mail, pretty frightening stuff.

Posted Mar 19, 2010 in

I remember reading a CenterWatch^SM article a few years ago regarding study coordinator recruitment initiatives and a best practices survey of coordinators.  As you can imagine, there were several references to how many studies the average coordinator handles simultaneously, the amount of time, on average spent on patient recruitment activities and other questions regarding the duties and responsibilities of the industry’s most crucial and yet, overloaded, contributors.

But the most staggering, eye-opening and disturbing  (I know, I know… three words that all mean the same thing) statistic mentioned in the article was that more than 35% of all study coordinators routinely mail informed consent documents to potential volunteers that they have never met.  My concern about this figure spans several relatively important topics and illustrates the rationale behind our continuous push for standardized informed consent assistance programs. 

Here are a few of my thoughts regarding the informed consent document and the incredible importance of increasing communication efficiency between coordinators and prospective volunteers. If the informed consent form is mailed to a prospective volunteer:

1. What are the chances that this long, legal document will be completely understood, thereby allowing for the best opportunity for enrollment in the study?
2. Is the pharmaceutical sponsor’s message being properly delivered in colloquial language and its intended tone?
3. What is the perception from the prospective volunteer’s standpoint of receiving a packet of legal information that is difficult to read and understand and may truly frighten the recipient?
4. In this day of news magazines, ambush journalism and otherwise extremely negative press, is it advisable to place the most important document in the hands of a naïve potential subject without reviewing the material face to face?
5. What are the chances of misperception of this important informatio n without proper guardianship?
6. What happens to the validity of the study when potential volunteers are made aware of the sponsor, the study drug and/or other information that is supposed to be blinded?

ICTS has long been a proponent of consent assistance and companion programs whose goals are to increase prospective volunteer knowledge of the study and procedures, the risks associated with participation, the commitment required, and building more accurate, timely and efficient communication with the investigator, coordinator and associated staff.  With the costs of finding truly pre-qualified candidates continuing to rise,it seems that maximizing the potential consent rate of these pre-qualified potential subjects is one of the most cost efficient means of meeting a study’s enrollment goals.

ICTS can build an informed consent assistance program to fit any clinical study and our experience in this area is second to none.  Recent ICTS video programs have experienced as much as a 190% percent increase in consented patients, further resulting in a 50% increase in enrolled patient retention.  It’s all about communication…providing the best information so your potential study candidates can make the most INFORMED decision to consent.