• How's that working for you?

    Posted Mar 31, 2010 in

    In these tough economic times it seems as though pre-emptive patient recruitment tactics have, once again, taken a back seat to the traditional model.  And until 2008, it seemed as though we had truly turned the corner in the mindset of pharmaceutical clinical research, moving toward patient recruitment solutions that were a match for the protocol rather than a last ditch attempt to stir some interest.

    Frightened executives are now depending on their contracting departments to make the tough decisions for study teams. This tends to result in costly rescue programs that could have been simple, highly effective solutions at a fraction of the cost.  These days there is no reward for thinking outside the box. The box has become impenetrable; built on the fear of being “downsized” for offering a new solution that hasn’t been tried and tested within the company.  It seems it is much safer to jump on the traditional band wagon, waiting for the miracle to happen all by itself and then throwing millions of dollars in advertising to rescue enrollment at the last minute. Since this has been done before, there is no risk to the person responsible for enrollment.

    CROs are being held responsible for determining the outcome of enrollment, yet are mostly unprepared to tackle this objective.  You choose your CRO based upon the quality of sites they present and the data collected, monitored and presented.  It’s true that your CRO has site relationships and that good site communication is essential in any recruitment and enrollment effort.  Some CROs even tout a patient recruitment department.  Most of the time this tends to be one or two people in charge of contracting an ad agency to rescue enrollment.  Few, if any, have an internal patient enrollment assessment function and fewer still have an arsenal of approaches that they initiate at study start up, introduce at investigator meetings and follow through with during the course of the study.  The CROs who do this generally have an alliance with an external patient enrollment company who specializes in these functions.

    It would seem as though logic should prevail when economics are the primary concern in the enrollment process.  We, and others in our field, have proven time and again that providing enrollment assistance from the study onset is a far more economical solution than putting the onus on your CRO.  Targeted communication solutions result in faster enrollment with high quality data collection, help your sites maximize their internal patient enrollment, increase the quality of physician-patient communication and save money in the process.  There is not now, nor will there ever be, a miracle solution that works for every study.  There are certain things that work better than others for certain protocols and even more to the point, your primary goals will have a dramatic effect on what works and what doesn’t.

    You patient recruitment and enrollment partner must have a vast arsenal of tactics at their disposal in order to meet the specific needs of your protocol.  They must be high-level thinkers with experience in problem solving.  They must be able to provide solutions that can be fully customized to your protocol and your patient population.  They must be able to identify where the challenges exist and how best to overcome the challenges.  They must be tireless in their efforts and not provide blue-sky projections.  Most of all, they should be focused on bringing you the highest quality patients, in the shortest amount of time, at the most cost-effective budget.

    So, if you’re currently relying upon your CRO to fulfill your study’s patient enrollment goals, or you are managing the process yourself with your sites, we ask the question…”How’s that REALLY working for you?”  If your answer is anything but “perfect,” you may want to find out how a targeted solution from a company that specializes in working through tough enrollment solutions will work.

  • Informed consent by mail, pretty frightening stuff.

    Posted Mar 19, 2010 in

    I remember reading a CenterWatchSM 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.

     

  • Internet Recruitment, not a "Field of Dreams"

    Posted Mar 3, 2010 in

    I remember a scene in the movie "Field of Dreams" in which a voice appears to Kevin Costner's character telling him "If you build it, they will come".  I've always enjoyed that line and have an even deeper love for it since one of my business partners developed a paraphrase to describe Internet recruitment websites.  The new axiom is "Just because you build it doesn't mean they will come".

    When setting an Internet recruitment plan into play, the most important thing to consider is "how will the prospective patients and caregivers find our website?".  Since the Internet is a "pull medium" as opposed to traditional media (radio, TV, print) being "push media", you can't go about the process of development the same way.  Internet users are seeking information and conduct web searches to "pull" information to their computers.  Traditional media is very intrusive and "pushes" information toward you whether you want it or not.

    We have talked about an integrated Internet plan in previous blogs, designed to create a buzz so that people can find your website and use your website as a center for credible information and a location from which to explore other ideas.  Your website is the hub of your recruitment plan, whether or not you choose to actually do any qualified pre-screening of potential volunteers on the site.  Use all of your recruitment resources to point to your website and use your website to point back to your recruitment resources, creating a circular information continuum.  This is how a buzz is created and how your web recruitment can become a success.  Without a host of different resources pointing to your website you will be sitting in the Iowa cornfield asking, "Why didn't they come?".

    A few tips for creating Internet buzz for your website:

    • If you have study brochures, newspaper ads, radio ads and or TV ads, make sure to include the study web address in all materials (this helps build information credibility)
    • Create an interactive website for the study with information about the condition, site locations, a pre-screening qualifier and links to other web resources like Twitter, Facebook and YouTube
    • Use keyword search advertising to help generate semi-qualified leads for your study
    • Make your website point to your Twitter, Facebook and YouTube pages and make your YouTube, Facebook and Twitter pages point to your website
    • Use alternate contact options in order to maximize potential interest in your study
    • Give social media a chance to "ramp-up"...it takes a bit of time to develop momentum
    • Monitor your results using analytical Internet tools and adjust your game plan spending accordingly

    An illustration of Internet buzz appears below.  Contact us for information about how to use the Internet and other recruitment methods to enhance your study.