P E D I A T R I C
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Pediatric Trials:
Patient Recruitment
Best Practices
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Pediatric Trials: Patient Recruitment Best Practices

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Recruiting clinical trial participants is hard. Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase. This report addresses some of the factors that negatively impact pediatric trial patient recruitment and poses potential solutions to those issues.

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Pediatric Trials: Patient Recruitment Best Practices

  1. 1. P E D I A T R I C patient recruitment Pediatric Trials: Patient Recruitment Best Practices Info@ISRreports.com ©2014 Industry Standard Research www.ISRreports.com PREVIEW
  2. 2. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 2 act with confidence Report Overview Recruiting clinical trial participants is hard. Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase. This report addresses some of the factors that negatively impact pediatric trial patient recruitment and poses potential solutions to those issues. 45Minute Telephone Interviews 64Pages 34Charts and Graphs 15Subject-matter Experts 1. Company Organization Company Structures Outsourcing Behavior 2. Patient Recruitment Specialists 3. Regulatory Difficulties Regulatory Guidelines Common Complaints 4. Difficulties of Enrolling Pediatric Patients 5. Enrollment Best Practices 6. Alternative Recruitment Methods Social Media Usage Patient Advocacy Group Usage 7. Current and Recently Completed Pediatric Clinical Trial Figures Report Structure: Methodologies: ISR conducted 45-minute in-depth telephone interviews with individuals with experience in pediatric trial patient recruitment. ISR reached out to pharmaceutical companies, CROs, academic medical centers (AMCs), research sites, and patient recruitment companies with experience in the process of pediatric trial patient recruitment. Secondary data were sourced from company websites, brochures, newsletters, presentations, government regulatory websites, and various other publications. Clinical trial data were gathered from www.clinicaltrials.gov. The titles below are held by our interviewees: • Clinical Project Manager • Clinical Research Coordinator • Director • Director, Office for Clinical and Translational Research • Director of Business Development • Director of Clinical Development • Director, Global Clinical Research • Director of Marketing and Patient Recruitment • Executive Director of Pediatrics and Rare Diseases • Pediatric Recruitment Team Member • Pediatric Strategist • Project Leader • Project Leader • Project Manager • Strategic Account Director
  3. 3. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 3 act with confidence What you will learn in this report: • Sponsor company organization and outsourcing behavior • Insight from pediatric patient recruitment specialists • Common complaints from sites, sponsors, and CROs/AMCs • Pediatric patient recruitment and retention obstacles and solutions from subject matter experts for overcoming those obstacles • Use and effectiveness of alternative methods (social media and patient advocacy groups) in pediatric trial recruitment • Number, length, and enrollment figures of ongoing pediatric trials based on data from clinicaltrials.gov • Best Practices for: Drug development planning Outsourcing decisions Recruitment advertising and strategy Alternative recruiting methods How you can use this report: • Anticipate potential problems in pediatric patient recruitment in order to reduce trial delays • Understand regulatory guidelines for pediatric trials and difficulties these guidelines pose for patient recruitment companies, sites, sponsors, CROs, and AMCs • Benchmark your company’s pediatric recruiting structure to those of other companies outlined in the report • Vendors: understand how to best market your pediatric recruitment capabilities • Understand the bigger picture of the pediatric recruitment process
  4. 4. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 4 act with confidence Table of Contents For full table of contents and additional sample pages, download the full preview from our website: http://www.isrreports.com/product/pediatric- trials-patient-recruitment-best-practices/
  5. 5. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 5 act with confidence act with confidence Introduction www.ISRreports.com ©2014 | Pediatric Trial Patient Recruitment Best Practices 8 Recruiting clinical trial participants is hard� Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase� This report addresses some of the factors that negatively impact pediatric trial patient recruitment and poses potential solutions to those issues� Recent research from the Pediatric Working Group of the European CRO Federation outlines obstacles identified by CROs and pediatricians who have been involved in pediatric trials� Recruitment issues are listed as the leading obstacle for CROs in pediatric trials� Main constraints observed in the past with clinical trials in children (multiple responses allowed): Source: European CRO Federation, Pediatric Working Group Clinical trial recruitment is a constantly evolving and heavily regulated aspect of the clinical development process� Further, pediatric clinical trials introduce another set of recruitment complications� The Official Journal of the American Academy of Pediatrics points to patient recruitment as the most difficult aspect of pediatric clinical trials� Navigating heightened regulations, identifying potential patients, attracting patients and patients’ families to the trial, and ultimately retaining patients and their families in a clinical trial make pediatric recruitment an uphill battle� The process of patient recruitment has multiple moving parts, each of which is analyzed in this report� Sponsors, CROs, academic medical centers (AMCs), sites, and specialized patient recruitment companies all play a role in patient recruitment� In some cases, some of these players work together to conduct the patient recruitment for a trial and other times a sponsor, CRO, AMC, site, or patient recruitment company will be individually responsible� This report examines how each of these players operates in the patient recruitment space and, further, how they interact with each other� www.isrreports.com  ©2014|  Pediatric  Trial  Patient  Recruitment  Best  Practices                        7     Introduction Recruiting clinical trial participants is hard. Recruiting pediatric clinical trial participants is even harder and with recent regulatory changes, the number of pediatric trials is expected to increase. This report addresses some of the factors that negatively impact pediatric trial patient recruitment and possess potential solutions to those issues. The pediatric trial environment is complicated and recent research from the Pediatric Working Group of the European CRO Federation outlines some differences between the obstacles identified by pediatricians who have been involved in pediatric trials and CROs. Main constraints observed in the past with clinical trials in children (multiple responses allowed). Source: European CRO Federation, Pediatric Working Group Clinical trial recruitment is a constantly evolving and heavily regulated aspect of the clinical development process. Further, pediatric clinical trials introduce another set of recruitment complications. The Official Journal of the American Academy of Pediatrics points to patient recruitment as the most difficult aspect of pediatric clinical trials. Navigating heightened regulations, identifying potential patients, attracting patients and patients’ families to the trial, and ultimately retaining patients and their families in a clinical trial make pediatric recruitment an uphill battle. 31% 38% 38% 3% 24% 7% 11% 19% 19% 30% 30% 44% 0% 10% 20% 30% 40% 50% 60% Financial concern/ low investment Low interest of sponsor Difficulties in obtaining Ethics Committee approval Parental consent Legislation/ administrative issues Recruitment issues CRO Pediatrician © Industry Standard Research Sample Page
  6. 6. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 6 act with confidence Sample Page act with confidence Company Organization www.ISRreports.com ©2014 | Pediatric Trial Patient Recruitment Best Practices 12 Company Structures ISR asked respondents how pediatric recruitment work is organized within their company� Based on the responses heard during the interviews, there are two main organizational structures that are detailed below� Therapeutic Focus Most of the individuals with whom ISR spoke including sponsors, CROs, and AMCs explained that their recruitment and trial operations functions were therapeutically aligned� In other words, those individuals responsible for handling non-pediatric cardiology studies also handle the pediatric cardiology studies� Under this structure, there is no department fully dedicated to pediatric studies� Subsequently, recruitment strategies for pediatric studies are often handled in the same manner as non-pediatric studies – a primary complaint amongst interviewees that will be further examined in later sections of this report� Cardiology CNS Oncology Respiratory Pediatric and Non-pediatric Pediatric and Non-pediatric Pediatric and Non-pediatric Pediatric and Non-pediatric © Industry Standard Research
  7. 7. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 7 act with confidence Sample Page For full table of contents and additional sample pages, download the full preview from our website: http://www.isrreports.com/product/pediatric- trials-patient-recruitment-best-practices/
  8. 8. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 8 act with confidence Ordering Information Industry Standard Research (ISR) is the premier, full service market research provider to the pharma and pharma services industries.  With over a decade of experience in the industry, ISR delivers an unmatched level of domain expertise.    For more information about our off-the-shelf intelligence and custom research offerings, please visit our Web site at www.ISRreports.com, email info@ISRreports.com, or follow us on twitter @ISRreports. About Industry Standard Research Save on this, or any ISR report, by creating a free account Register now • Receive a $250 instant credit towards any ISR report • Earn 10% credit towards all future purchases • Receive advanced notifications on ISR’s latest reports and free resources For pricing and ordering information, visit our website: http://www.isrre- ports.com/product/pediatric-trials-patient-recruitment-best-practices/
  9. 9. www.ISRreports.com ©2014 | Preview of: Pediatric Trials: Patient Recruitment Best Practices 9 act with confidence www.ISRreports.com ©2013 | Preview of: Benchmarking the Pharma Industry’s HEOR Functions 9 act with confidence www.ISRreports.com ©2014 | Preview of: Benchmarking European Investigator Payments 10 act with confidence www.ISRreports.com ©2013 | Preview of: Benchmarking the Pharma Industry’s HEOR Functions 10 act with confidence The ISR Difference Custom-quality syndicated market research www.ISRreports.com ISR's Reports The Common Syndicated Reportvs. How confident are you? vs. DataCollection ISR's proprietary data collection tools and channels support fast, high quality data collection Struggle to recruit the right targets and enough of them vs. SampleSizes Robust sample sizes that instill confidence Often insufficient industry representation that leaves you defending results vs.vs. Research methods Mostly primary research; always appropriate for the topic One size fits all; usually publically available data vs.vs. Respondents Sophisticated screening ensures genuine decision-makers Undisclosed methodologies and respondent demographics vs.vs. Analysts Decades of experience means more insights that are immediately usable Junior analysts capable of reporting numbers

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