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Clinical Trial Educator - Fact sheet

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Clinical Trial Educator - Fact sheet

  1. 1. Clinical Trial Educators The key to faster enrollment and fewer barriers in clinical trials Because speed and efficiency have never been more critical to the success of your clinical studies, Quintiles now offers a unique resource proven to compress timelines in clinical trials. Our specialized Clinical Trial Educators can accelerate patient enrollment, improve site performance and help streamline all your studies in ways no other team member can. One Solution to a Wide Range of Problems Even with careful planning, potential barriers can derail your study schedule and results at any stage. Competition for sites may be intense, slowing the selection process. Activated sites may fail to focus aggressively on patient enrollment or lack the network contacts to find a particular patient population. Once enrolled, patients may have difficulty adhering to a complex drug or device protocol. Other obstacles can arise in data collection and reporting, protocol errors, regulatory approvals or patient retention. Besides increasing your direct costs, such problems waste precious time, eating away at your patent protection window or threatening the successful completion of your trial. Specific issues vary, but many stem from three common denominators: a need for better education (site staff and/or patients), increased communication and stronger site relationships. By providing solutions to improve all three, Quintiles Clinical Trial Educators have achieved dramatic results in shortening clinical trial timelines. Who are these resourceful professionals? Most are registered nurses, but they may also be certified therapists, pharmacists, dietitians or educators. All are highly specialized in a major therapeutic area and highly trained in the planning and operation of clinical trials. The Quintiles team will work to identify the best profile for your initiative. Educators are generally, full-time Quintiles employees, dedicated to a single trial or sponsor. While their training and attention are extremely focused, their singular role in a clinical trial enables them to contribute in several key areas. Foremost among these is patient enrollment. Increased Patient Enrollment A Clinical Trial Educator’s primary goal is to accelerate patient recruitment and enrollment. The reason is simple: 80% of trials fail to meet their initial enrollment quotas on time, risking losses of $600,000 to more than $8 million in revenue each day a drug is delayed.* The first noticeable effect of having a team of Quintiles Clinical Trial Educators on your study is a marked increase in site motivation to screen and enroll patients. The Educators’ consistent, visible presence — by regular site visits, email and phone — keeps your study top of mind and on track. Beyond that, Educators fill in recruitment gaps and speed enrollment by: Educating the primary investigator and site staff in successful>> enrollment techniques Educating other site-affiliated health service professionals who>> may help identify patients for enrollment Accessing untapped recruitment pathways through referral>> networks acquired from past experience, professional contacts or local inquiries Informing health care facilities (e.g. emergency rooms) that>> may refer potential study patients Reducing otherwise excluded patients from trials through>> identification prior to initiation of other therapies Sharing best practices in focus groups of study coordinators or>> investigators, a significant value-added service clinical | commercial | consulting | capital FACT SHEET Clinical Trial Educators
  2. 2. An example: In some studies, inexperienced study coordinators have failed to enroll eligible patients simply because of poor recruitment presentation skills. In these cases, Clinical Trial Educators provided remedial training, improving the consent ratio significantly. They also re-contacted and enrolled patients who previously declined. Overall, sites with Educators consistently exceeded their projected enrollment goals. In one study, the monthly enrollment increased by as much as 85%. The average increase for all sites was 34%. Faster Site Identification and Selection Since Clinical Trial Educators understand the profile of a successful site for a specific therapeutic area, they bring considerable insight to the identification and selection process. They also provide a great deal of active prospecting through personal contact. Educators frequently call on investigators who are simply unaware of study opportunities. Sites that initially declined have been revisited and convinced to sign on. Even before consenting sites are activated, Educators can help them lay the groundwork with best practices and proven processes for enrolling the first patients. Positioning sites for successful enrollment in this way saves valuable time during start-up. Specialized Training, Problem Solving and Patient Coaching Quintiles Clinical Trial Educators quickly become an integral part of your study team. They are the sponsor’s “face” and trusted representative on the site, the go-to person for information, advice, contacts and problem solving. With their continuous presence from site identification through completed enrollment, Educators play flexible, dynamic roles as trials progress. For example, they train the site staff in trial protocol and review it frequently—a critical refresher for coordinators who are managing several studies at once. They deliver and explain the proper use of your tools, from data entry technology to medical devices to websites. Throughout the trial, they help resolve problems and potential bottlenecks quickly, putting site personnel in communication with precisely the right person in your organization. For all these reasons, having a team of dedicated Clinical Trial Educators on your study gives you a stronger relationship with investigators and better site performance. Quintiles Educators have earned glowing endorsements from sponsors, academic research site managers and study coordinators alike. Educators also work closely with your Medical Science Liaisons, increasing your access to primary investigators and site staff. Liaisons who worked with our Clinical Trial Educators rated them highly (over 4.6 on a 5-point scale) on knowledge, usefulness and their own satisfaction with the interaction. Working directly with patients and their caregivers is another service provided by our Educators. In studies involving a complex drug regimen or device usage, a professional with therapeutic expertise can be invaluable as a protocol instructor and coach. The extra training can improve patient retention levels as well. The advantages of having Clinical Trial Educators on your study will depend on the nature and stage of your trial and the particular barriers encountered. In general, the studies that benefit most are in highly competitive areas of therapy, involve a difficult therapeutic protocol, require complex inclusion/ exclusion criteria or involve a patient population with uncommon medical conditions. Accelerate Your Next Trial from the Start Clinical Trial Educators bring a unique combination to your study: specialized therapeutic expertise and research know-how based on proven best practices. Only Quintiles has the depth of experience and breadth of resources to offer this innovative resource, a solution that’s now available for all of your clinical trials. To find out how we can help you speed enrollment, shorten study timelines and maximize your long-term revenue potential, contact us today. Email: patientcentric@quintiles.com 10 Ways Clinical Trial Educators Can Add Value to Your Study Accelerate patient enrollment1. Facilitate site identification and selection2. Increase site motivation and top-of-mind3. focus on your study Educate site staff on protocol and best practices4. Educate patients on therapy and compliance5. Improve patient retention6. Assist in resolution of site issues7. Enhance communication with sites8. Expand medical science liaison’s access to9. investigators, opinion leaders Compress your study timeline10. (Endnotes) * Source: Cutting Edge Information, “Web-Based Patient Recruitment” Copyright © 2010 Quintiles. 04.03.18-012210