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Physician Referral: From Zero to Global Video in less than 3 weeks.
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.
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Enrollment Feasibility: Understanding Patient Populations and Motivation
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.
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How's that working for you?
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.
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Informed consent by mail, pretty frightening stuff.
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:
- What are the chances that this long, legal document will be completely understood, thereby allowing for the best opportunity for enrollment in the study?
- Is the pharmaceutical sponsor’s message being properly delivered in colloquial language and its intended tone?
- 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?
- 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?
- What are the chances of misperception of this important informatio n without proper guardianship?
- 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.
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Internet Recruitment, not a "Field of Dreams"
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.
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A Bit of a Diversion
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.
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Is it time for a rescue recruitment intervention?
Waiting to the very last minute before securing a rescue recruitment solution can be a very costly and risky proposition. Understanding when to initiate a rescue of your study’s enrollment is a matter of weighing the costs, time and quality benefits of both your current enrollment curve and the rescue initiative itself.
A good rule of thumb to use in most studies is to begin your enrollment curve evaluation at the time point that represents 25% of your enrollment period (3 months for a 1 year enrollment period). If your study has not enrolled 50% or more of it’s goal within 25% of your enrollment period, there is a strong likelihood that you will fail to meet your enrollment goals by the end of your study period without an intervention. Keep a watchful eye on your enrollment utilizing weekly enrollment figures to graph the curve and visualize its peak and eventual downturn.
Most sites reach their highest motivation point immediately following the investigator meeting and their enrollment is focused on your new study. There is a quick peak in site initiatives, utilizing recruitment stipends and placing your study at the top of their list of priorities. But, site initiated enrollment decreases over time as recruitment stipends are depleted and the challenges inherent in any study enrollment are realized. Investigator fatigue sets in and coordinators become frustrated with the program.
If the enrollment curve has shown a downturn illustrates a stable but small weekly figure for three weeks it is time to pursue rescue intervention. Using formula above, this should leave you with approximately 50% of your enrollment period remaining in which to implement your rescue solution. This will allow your team to maximize the number of solutions available to help secure enrollment. The longer you wait to begin an intervention, the smaller the pool of applicable solutions and the greater the cost of the initiative.
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Using the Internet to Leverage Study Enrollment
A recent conversation with a member of a client's proposal evaluation team brought to light an issue involving the use of web advertising and social media to support a patient enrollment program. In the client's words they had "tried using web advertising in the past and received no attributable results”. This was no surprise to hear since these words have been uttered on numerous occasions in meetings with current and potential sponsors.
The Internet can be a great source of patient inquiries for clinical studies when the study population or caregiver population for the indication are heavy web users and as part of an integrated model to develop inquiries. As with all strategies for patient enrollment, the use of an Internet campaign is only a single tool in the complete enrollment strategy.
The true advantages of an Internet strategy as part of an enrollment campaign are:
- Ability to narrowly target specific populations
- Ability to provide a level results-driven solutions for enrollment
- Ability to engage the study population with interesting and interactive content
- Communicating with patients and caregivers in their preferred media
Here are a few tips for the use of the Internet for any protocol:
- Ensure patient or caregiver population is searching the web for treatment options (is the internet an appropriate tool).
- Develop, at minimum, a study branded web site hosting information about the study, the study locations and multiple forms of screening and contact (give the patient or caregiver options)
- If using a keyword search tool such as Google, Yahoo! or Bing, develop the study website in search engine optimized platform (make the keyword searches work for the study)
- Use the study website as the information hub for all web tactics
- Use more than one internet search engine to drive inquiries to the sites
- Social media usage (Facebook, Twitter, YouTube, etc.) should drive interest to your study website
- Integrate several appropriate media to ensure coverage of the likely study population
- Use analytical data to improve operational efficiencies within the campaign (which keywords are most efficient, which sites are driving the most inquiries)
- Make all site related and traditional advertising point to the study website
The Internet can be a viable source of patient inquiries for many studies. Some platforms require development of SOPs to insure IRB/EC compliance and some tactics may be more appropriate based upon the motivation of the patients being sought for the study.
We have attempted to provide some of the basic ideas for Internet advertising but the protocol will determine the requirements and macro-tools that might be implemented. For more specific information about Internet advertising for your protocol, please contact ICTS vice president of business development, Michael Ohrwashel.
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Happy Holidays From ICTS
Best wishes to all of our clients, friends and family during this holiday season. May your holidays be rewarding and joyful.
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Social Media Has Come of Age
In the past few years we have become acutely aware of the use of Internet social media websites serving as sources of information about everything from family reunions to recipie sharing. There is no doubt that social media has a place in clinical trial enrollment and ICTS has been at the forefront of social media use for this purpose.
As Erik Qualman states in his book, SocialnomicsTM, social media is unquestionably a powerful communication entity. There is a video on our website produced by Erik that is a true eye opener reagrding the impact of social media. You can view Erik's video and a link to his book by clicking this link http://icts.us/page/socialnomics
Although the FDA is currently examining use of social media in pharmaceutical marketing it is the ultimate responsibility of the IRB/EC for a study to monitor use of social media for clinical trial enrollment. ICTS has developed social media use SOPs that have helped our clients get clearance for social media blogging as part of an integrated enrollment campaign. You can contact Michael Ohrwashel, VP of business development for more information. mbo@icts.us
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