• Orphan Drug Studies and Difficult Patient Populations:

    Posted Jan 25, 2012 in

    Risk AND Reward

    The purpose of any recruitment strategy is to accelerate patient randomization by providing efficient solutions. As the industry leader in innovative patient enrollment tactics ICTS is constantly developing new and more efficient strategies. Many of the innovations that we developed were designed to meet the specific needs of difficult protocols and are now considered industry standards.

    Social media has now reached an effective saturation point as a cultural medium and is beginning to replace national, charitable foundations as the primary resource for patient and caregiver advocacy and support. The socially interactive nature of sites like Facebook, twitter and others have made possible the rapid increase in personal healthcare discussions and the formation of many grassroots, indication-specific, interactive groups and personal experience blogs.

    With the amount of time, effort and chatter being devoted to social media and patient recruitment, it would appear that someone has discovered a utopian strategy to fill all the needs of every clinical trial. While it's true that social media can be an effective tool, IRB restrictions on page content and visitor interaction have reduced clinical trial social media pages to nothing more than extended information advertising. As a result of these restrictions the patient enrollment community has effectively taken the “social” out of social media.

    Using social media keyword and key phrase search advertising to bolster the social media aspect of a study website has become commonplace as a cost-efficient means of reaching potential patients for most average to high prevalence rate indications. ICTS was one of the first companies to utilize social media both organically and as an advertising resource and, we continue to utilize social media as a portion of enrollment strategies for many protocols. 

    However, the specific challenges inherent in clinical trial enrollment for indications with very small, often orphan, populations make most currently acceptable enrollment strategies inefficient in both time and cost. In these types of studies the prevalence of academic medical centers as investigator sites, further complicates the enrollment process due to internal HIPAA guidelines and local IRB's. Standard patient recruitment strategies often prove to be costly which can drive a study team to maintain status quo rather than engage in an active patient enrollment plan.

    Any communication for the specific purpose of developing inquiries for a clinical trial or clinical research site is regulated by both common rule and IRB guidelines. In most cases, getting communication pieces approved by a local IRB can be a long process. To expedite the development timeline of any recruitment effort involving high percentage of academic medical centers as investigator sites, a new paradigm for patient enrollment philosophy must be explored.

    What if it was possible to develop a viable resource for clinical enrollment for studies that are small in scope and rely heavily upon key opinion leaders and academic medical centers?

    If it were possible to utilize social media to engage potential patients and caregivers in healthcare discussions, while maintaining a conservative respect for IRB guidelines, what kind of structure would it have?

    Is there a way we can engage patients and caregivers in active discussions of indication specific healthcare issues, attitudes towards clinical research, and lifestyle and qualifying information that can be used as a patient recruitment tool?

    At ICTS, we have been conducting indication specific focus groups as a resource for engaging patient discussion and providing consumer-based healthcare information research for many years. Recently we began conducting focus group recruitment and research online via Facebook, reducing both time and cost and process. It is this blend of our experience with focus group research and social media that led to the development of our most recent innovative patient enrollment tactic.

    The on-line focus group was only a step in the evolution of our new tool. We now have the means to rapidly accelerate the enrollment process for even the most difficult and smallest of protocols. And we can do this in a phenomenally cost effective manner.

    Any new tactic comes with a certain amount of risk attached. The key is to mitigate risk by assessing common sense values inherent in the tactical design. We build along the common thread between currently acceptable tactics and the innovation. This is the practice employed by ICTS in the development of all new tools and we have never failed to deliver results. A little risk, especially in a tactic with a far lower cost than status quo, can go a long way to delivering a great reward.

    For more information about this ICTS innovation, please contact Michael Ohrwashel, VP of business development via email or phone.

  • YouTube: ICTS Acute Condition Patient Recruitment Video Series

    Posted Feb 5, 2011 in

    Just finished uploading a 3-part video series titled Acute Condition Patient Recruitment Stragies That Really Work.  You can watch the videos by clicking on the YouTube link on our home page.

  • ICTS Patient Recruitment Video Magazine on YouTube

    Posted Jan 12, 2011 in

    http://youtube.com/user/ICTSpatientrecruit

    ICTS Patient recruitment video magazine is a new feature providing insights into patient recruitment, enrollment, retention and pre-launch campaigns.  This is a new feature from ICTS and is available for viewing on our YouTube page. 

    We welcome your comments.

  • Under-representation of Ethnic Populations in US Clinical Trials

    Posted Nov 3, 2010 in

    Don’t Bury the Lead. 

    As I do most mornings, I began the day, a few weeks ago, by browsing through the news on a local television station’s website. In the Health news, I found an article entitled “Blacks under-represented in Clinical Trials” I found it interesting that of all the reasons listed for the low levels of African-American participation in clinical research studies that the last reason (perceived, by me, as least important) was “…and, some might say, a historic distrust of the medical community”. Wow...my mind is still reeling a bit from what I’m thinking is an under-representation of the entire issue by the reporter, a Medical Doctor, none-the-less. Talk about “burying the lead.”

    In my experience there is not an African-American person who will not immediately recall “Tuskegee” when engaged in any discussion of clinical research. The Tuskegee Syphilis Study has been called “arguably the most infamous biomedical research study in US history”1. The establishment of the Office for Human Research Protections (OHRP), a division of Health and Human Services (HHS), and regulations requiring Institutional Review Boards (IRB) are directly attributable to this study. Forty years of the US government violating nearly every clinical research participant protection we now take for granted. This is the study that “some might say” was solely responsible for the development of the “Informed Consent” process and form; although Oak Ridge can certainly be added as another resultant case. 

    At almost the very beginning of my career in the clinical research industry I was introduced to the issue of low participation levels within ethnic populations, specifically within the African-American community. It was when I was asked to develop an enrollment campaign for an extremely large, long-term study of hypertension that I began to receive my true education. Since the study was sponsored by the National Institute of Health (NIH), there was a mandatory African-American participation level. I had already discovered that certain populations respond to medications differently and research studies were supposed to be designed to include those populations with high prevalence rates. Such is the case with hypertension within the African-American community.  What stuck me as strange, though, was the minority population mandate.

    As a matter of due diligence I asked a friend of mine, an African-American communication consultant, to assist me with the development of my outreach plan. Treating this as a learning opportunity, I decided the best approach would be to act as a reporter gathering “deep background” material: ask questions that lead to follow-up questions; follow the path no matter where it leads.

    I remember as if it were yesterday… giving my friend some background of the current study and the “African-American population mandate”. I opened with a simple question of why would the government feel the need to mandate ethnic participation in a clinical trial? It would seem to me that clinical research study populations would automatically be representative of the percentage of each ethnic group within the general population. The answer came back to me like “the shot heard around the world”… one word… one very curious word.  Tuskegee. 

    “Tuskegee?  What’s Tuskegee?”

    OK… so I was ignorant, having absolutely no concept of the can of worms I was opening. I began my career in research as a media buyer two years earlier, in 1995, having come from the broadcast industry. I had prided myself on reading everything about clinical research I could get my hands on… joined ACRP and The Drug Information Association (DIA), subscribed to R&D Directions, The Pink Sheet, CenterWatch and other industry publications and was engaged in daily conversation with people in research. How could I NOT have heard of Tuskegee?

    Now, fifteen years into my career in developing strategies for clinical trial recruitment and enrollment, the issue of under-representation is still at hand. So what can be done to ensure better clinical research representation within all ethnic groups within the United States? The answers are simpler than one would think. To arrive at conclusions, a quick assessment of the major roadblocks is key.

    Within immigrant populations the issues are relatively the same but, for some very different reasons. Heavily based upon extended families, immigrant populations within the US often cite a complete distrust of medical record keeping as an issue in both engaging in regular medical care and participating in research. There is a perception that medical records will be shared among various government agencies, not the least of which is the Immigration and Customs Enforcement (ICE). The primary fear is that tracking of medical records may reveal details about immigration status of themselves, friends and/or family members.

    The two primary issues here are trust and comfort, in that order. It is imperative to establish trust with prospective volunteers and develop comfort levels with research team members. 

    Based upon my discussions with medical professionals within various ethnic groups, there seems to be a lack of “in-culture” research physicians and staff members with whom the ethnic populations can engage. For most ethnic sub-cultures, trust is established at a much higher rate with those who are from the same culture. In order to communicate the protections established for research participants it is of the greatest importance that the person delivering the message be in-culture with the intended message recipient. Comfort levels are established in the same fashion, but trust must be established before comfort can be obtained.

    A change of population-specific perception is required in the development of a communication model between medical service providers and patients. We must provide information based upon easily attributable facts. Let’s engage local clergy and other social groups within the culture. Let’s provide a culturally soothing environment. Most importantly, do not fear the big issues when speaking with a prospective research volunteer… tackle the big issues proactively. Pre-empt the inevitable. The perception of fearlessness establishes a level of trust and comfort with the patient (the patient begins to mirror your behavior). Most importantly, allow your patient to feel they can ask any question without being regarded as less than equal.

    Since study coordinators are in the best position to initiate contact and develop peer relationships with patients, a great deal of the communication burden rests on their efforts. The study coordinator is the backbone of successful clinical research and should receive ample communication training.

    Trust begins on the first contact so the person answering the phone and greeting the patient on the first office visit and all subsequent contact staff also must be made well aware of potential patient perception.  This is where in-culture physicians, coordinators and ancillary office staff become a highly valuable resource.  We communicate and accept ideas at a much more efficient rate with those whom we most readily identify with and hold in high regard. If we want to break through the Tuskegee barrier, we must first recognize its existence and then develop clinical study strategies to overcome the barrier… beginning with but not limited to, contracting African-American research physicians.  The same goes for other ethnic populations.

    “Burying the lead” only serves to further the problem. Open, truly dyadic communication from in-culture researchers will open the door to greater ethnic clinical research participation.

     

    References:

    1.    Katz RV, Kegeles SS, Kressin NR, et al. (November 2006). "The Tuskegee Legacy Project: willingness of minorities to participate in biomedical research". J Health Care Poor Underserved 17 (4): 698–715. doi:10.1353/hpu.2006.0126. PMID 17242525. PMC 1780164

  • Physician Referral: From Zero to Global Video in less than 3 weeks.

    Posted Jun 18, 2010 in

    Time to toot our own horn a bit. 

    ICTS has always been known for meeting agressive study team deadlines but we had a recent experience that truly tested our metal.  A study team for an acute indication needed in-hospital physicians to be able to access a modular instructional video about the research study and, due to the seasonal nature of the acute condition, we only had two weeks to get the video up on a secure, high resolution web server.  This is to say that we had two weeks from the day of our meeting with the study team, prior to contract, to get the video modules on the web in English.  And another two weeks to subtitle and prepare an international website in 17 addtional languages for 20 countries.  Just the discussion that day made me sweat!

    From the day of the meeting ICTS had to scheudle 2 locations for a high-resolution video shoot, schedule multiple editing personnel and go through multiple rounds of revisions to the final cut of the video.  This includes:

    • Two protocols, one for US, Canada and Mexico...the Other for 20 countries, 17 languages plus English, including many in Eastern Europe.
    • ICTS scripting of first draft of the audio and video portions of the video in 3 days
    • Scheduling first location (in hospital) 4 days from our first meeting
    • Editing the script the night before the first location shoot
    • Scheduling of first round of editing beginning day 5 from our meeing (in differnt state than the shoot)
    • Schedule second-on location shoot for day 6
    • Schedule part two editing to begin on day 7
    • Days 1-13: Build secure log-in, two study central web portal with pages for each study and video links by county.
    • Days 8-12 for editing of video and revisions for both protocols, 7 modules, total (2 study specific for each study, 3 shaed with both studies)
    • Day 13 for editing of final cut, conversion of each English module to two formats for web view (Flash® and Windows® Media Viewer) in very high resolution, widescreen view (more than 70 Mb per module).  Translate into Spanish for Mexico.  Subtitle and format for web view in Flash and Media Windows Media Viewer.
    • Day 14:  Upload of all video modules and testing of North America website.  Publish website and send study team link to send to their hospitals in the US, Canada and Mexico.
    • Days 14-17:  Translations for 17 additional languages of second study video modules.  Subtitling of 5 modules for each language.
    • Days 17-20:  Receive final videos, convert to Flash® and Windows® Media Viewer formats in very-high-resolution and upload to study website.  Test study website.  Send email to study team for notifications of all hospitals worldwide.

    Now, before anyone thinks that this the typical video production schedule, I need to point out that our average production time without translations is usually about 12-14 weeks.  This includes revisions to the script, scheduling of video shoot and editing and all the other elements of our high definintion processing.

    The point is...ICTS will deliver the goods to meet your deadlines (not matter how little sleep we get in the process).  If you are up against the wall and need fast, very high quality work, call Mike today.  You'll be glad you did.

  • Enrollment Feasibility: Understanding Patient Populations and Motivation

    Posted Apr 13, 2010 in

    Key opinion leaders (KOLs) have long been contracted for assistance in the development of protocols for clinical trials.  Subscribing to “in-the-field” empirical and anecdotal evidence assists in a more patient friendly research study by taking into account the many lessons learned in the treatment of patients with chronic, acute, infectious, seasonal and terminal illnesses.  The study team responsible for protocol development generally spends months in discussion with their KOLs determining the procedural and control aspects and how they play a part in data gathering and, ultimately, proving safety and efficacy.

    It has been our experience, however, that all-too-often the potential for enrollment and retention of the at-large patient population is addressed after the protocol has been approved.  Furthermore, it tends to be viewed as a mathematical rather than motivation based function of the study.  Many times we have seen patient enrollment feasibility as a direct function of the number of patients required for enrollment divided by the number of sites, divided by the number of months provided for enrollment… resulting in average number of patients per site per month.  Although it is important to know what the enrollment requirements are for your sites this form of assessment is not patient enrollment feasibility.

    In order to fully examine enrollment feasibility for any study it is of the utmost importance to first understand the life of the average patient, the low maintenance patient, the patient that falls into the numerical center and those in the extremes of treatment (high, low, average and mean). What is a typical day like for each of these patients and what is their probable motivation for enrolling in a clinical research study?  Are there others likely to assist in decision making for the patient’s healthcare and research needs?  What functions of a clinical study are most likely to stand in the way of general research interest, enrollment and follow-through?

    Motivation comes in the form of pain abatement, easing of irritation, co-morbidity, mortality, motility and personal gratification.  De-motivating factors may include fear, ignorance, inconvenience, maintaining status-quo, disinformation (negative press), poor physician-patient communication and the ominous informed consent procedure. 

    Additionally, we need to fully understand the socio-economic status, the information gathering and processing standards, the stigmatic nature of the condition and how it affects patient’s willingness to provide information at pre-screening and the social circle of information sharing between patients and caregivers. 

    This is not new information here.  Abraham Maslow proffered his “hierarchy of needs” in 1954 (see diagram, below).  Fundamental to the understanding of motivation is the level at which certain factors influence our decisions.  It can be ascertained that all but the first level of Maslow’s hierarchy can apply to patient motivation in the context of the global clinical trials as a whole. This has become a standard of psychology education in the modern world and should be a standard in enrollment feasibility assessment.

     

    Feasibility then, is a product of several aspects affecting the day-to-day life of patients within the specific protocol population.  The best sources of information of this nature are your study team, your investigators, your KOLs, and the patient population themselves.  Although much of this information may not be in the form of empirical evidence, your entire team’s experience in the particular disease state, combined with the knowledgebase accumulated through hands-on treatment, anecdotal observances and lessons learned should be the basis for determining the feasibility of the study’s enrollment objectives. The ultimate goal of any true enrollment feasibility assessment is to be able to predict which enrollment tactics will result in the most time and cost efficient solutions to your enrollment challenges. Addressing motivational factors in your recruitment, enrollment and retention tactics will yield a more effective communication model between your sites and their potential subjects, further resulting in a far greater enrollment rate and more accurate data.

    Understanding the direction and rate of communication flow will help in the assessment of recruitment and enrollment tactics that fall into the categories of common sense and verifiable assessment.  It is also important to determine which inclusion and exclusion criteria will most likely result in disinterest and what points in the inquiry through evaluable patient lifecycle will result in population loss.

    Successful enrollment is a function of patient communication and the sooner you address the motivation of your potential patient population the sooner you will meet your study objectives. Use your investigators, your study team, and don’t rely entirely on empirical evidence in assessing patient motivation for entering your study.  Be creative, use common sense and take a few inferential leaps when considering your enrollment objectives… your study participants will be glad you did.

  • 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.

  • A Bit of a Diversion

    Posted Feb 23, 2010 in

    Every now and again we put on our geeky creative caps and give our own company marketing a whirl.

    This week's challenge was a simple banner ad to be placed as part of an editorial effort in conjuntion with Future Pharmaceuticals publications.

    The objective, as we often tell our clients, is to be direct and concise with your message.  Humor can be used but the keyword here is sparingly.  When using humor, make sure that it's actually funny...and not just to yourself. (This is something for which my partners keep me well in check.)

    That said, I thought I would share with our fine visitors some of the banner ads that didn't make the cut....actually, all of these were created solely for our own enjoyment.