Enrolling Difficult-to-Recruit Populations Case study on recruiting newly diagnosed and control subjects Sunday, April 15, 2012 8:00am 1 1
Disclosure Joseph Jankovic, MD, Professor of Neurology , Distinguished Chair in Movement Disorders, Director , Parkinson’s Disease Center and Movement Disorders Clinic (PDCMDC), Baylor College of Medicine, Houston, Texas is a grant awardee of The Michael J. Fox Foundation for Parkinson’s Research (MJFFPR). Christine Hunter, RN, BSN , Research Nurse Manager, is an employee of the PDCMDC, Baylor College of Medicine. Claire Meunier is an employee of the MJFFPR. 2
Learning Objectives • Identify challenges in recruiting study subjects and healthy controls for clinical, particularly observational, non-therapeutic, trials. • Analyze crucial characteristics of difficult-to- recruit study population that can be leveraged to develop a recruitment strategy. • Describe and implement a tailor-made recruitment plan for these cohorts. 3
Background and Introduction to the Parkinson’s Progression Markers Initiative (PPMI) 4 4
Background • Parkinson’s disease (PD) is a chronic, progressive, degenerative neurological disorder that results from loss of cells that produce dopamine in the brain. • PD affects nearly one million Americans and 5 million individuals worldwide. • Motor symptoms (tremor, bradykinesia, rigidty, and postural instability) are the cardinal features of PD. • Most PD patients also experience non-motor symptoms, many of which can precede and may be more troublesome than the motor symptoms. These include cognitive impairment, mood disorders, sleep difficulties, loss of sense of smell, unexplained pains, constipation, speech and swallowing problems, drooling, and low blood pressure when standing. • Available therapies, such as levodopa, improve symptoms, but over time become complicated by diminishing or adverse effects; no disease modifying therapies currently exist. 5
Rationale for focusing on biomarkers • There are no biomarkers for PD diagnosis or progression. • Markers would facilitate more reliable diagnosis and more precise measurement of disease modification. • Disease-specific and sensitive biomarkers are needed for therapeutic trials. • The Michael J. Fox Foundation for Parkinson’s Research recognized this unmet need and launched PPMI in the spring 2010. 6
Parkinson’s Progression Markers Initiative (PPMI) • Goal: To create a biorepository of comprehensive data and samples that are available to any researcher in the scientific community to verify markers of PD progression. • Cohorts of subjects to be recruited across 25 sites: – 400 de novo PD patients (dx within 2 years, unmedicated before inclusion and as long as possible after enrollment) – 200 Controls (no 1st degree blood relatives of PD patients) – ~20 PD and 10 controls per site • Subject commitment: – 3-5 years, 4 visits in the first year with 2 visits each year thereafter – Alternating half and one-and-a-half day visits that consist of extensive testing and sample collection (including 7 lumbar punctures) 7
Schedule of Activities 8
The Challenge: Recruiting Newly Diagnosed and Control Volunteers 9 9
Challenges in Recruiting Newly Diagnosed Subjects • Patients are diagnosed in the community – only the most proactive see a specialist to confirm diagnosis. • Competition between physicians for patient care and loss of income make community physicians hesitant to refer their patients for research. • Most patients are immediately medicated (or even prescribed drugs to confirm their diagnosis). • Patients are emotionally overwhelmed at the time of their diagnosis and immediately want to seek some treatment. 10
Challenges in Recruiting Controls • Lack of a personal diagnosis of PD. • Commitment to participate in invasive and extensive testing to contribute to research for a disease they don’t have. • Belief that they aren’t as important as people with PD for research. • Compensation for participation is nominal. 11
Identifying Recruitment Opportunities The PPMI Recruitment Plan 12 12
Approach • Conduct due diligence calls with all sites – How do you plan to recruit? – What ideas do you have for how we could enhance recruitment globally? • Cull recruitment best practices from literature and other recruitment information sources • Form a Recruitment and Retention Working Group to advise along the way • Formulate a recruitment plan • Implement tactics and strategies in tiers, evolving priorities as needs shift 13
Tiers of the Recruitment Plan • Tier 1: Preparing for launch and site activations (~first 6 months) • Tier 2: Ongoing support for recruitment of both cohorts (~6 months in to 1.5 years in) • Tier 3: Tailored approaches for specific needs (~rest of the study) 14
Tier 1: Preparing for study launch • Develop a suite of communications and materials – Start with case making: why is this important, what could we learn – Address FAQ’s up front – Have a spectrum of materials that can be tailored – Address multiple audiences and equip people to spread the message for you • Establish a study call center • Engage and onboard a media and PR agency • Initiate monthly recruitment calls with site teams – Update on Progress – Share new ideas – Celebrate successes 15
Tier 1: Site activations • MJFF “Salon” event in each area to announce the study, share study details and promote who is being recruited to patients • Issue press release announcing launch of study at each site; field follow on media inquiries • Key site activities – Tagging charts – Reminders to colleagues about study and I/E criteria – Support group outreach – Presentations at patient symposia and education events – Routine recruitment tactics at study launch were implemented 16
Tier 2: Ongoing Support • Ongoing media support as sites identified study subjects who were willing to serve as media ambassadors • Strategies to recruit the newly diagnosed – Physician salons to reach out to MD’s in the community • Assure that patient care remains with the referring MD • Make it easy to refer – fax referral form • Thank MD’s who refer with a personal note • Opportunity for sites to leverage this to develop a referral network • Strategies to recruit controls – Appeal to friends and family members who accompany PD patients to clinic visits – Encourage PD subjects to “bring a friend” on board to do the study with them 17
6 month assessment of recruitment progress SUCCESSES • Controls are easier to recruit – progress is better than projected • Female subjects-- both PD and controls-- far outpace the rate of recruitment of men in both categories • LPs are not a deal breaker for participation CHALLENGES • Better than expected recruitment of female controls; Need more males controls 55+ to balance this • Lagging in PD recruitment 18
Tier 3: Tailored approaches for male 55+ control recruitment • Male 55+ control recruitment – Identified veterans as a key group to tap – sense of altruism and volunteerism, connection to neurologic conditions more broadly, relatively easy to get a targeted list – Conducted mailings from one PD patient who is a veteran to male veterans 55+ in 4 markets 19
Tier 3: Tailored approaches for PD recruitment • Initiate online ads targeted to the newly diagnosed • Targeted search on Fox Trial Finder to identify new leads • Outreach to imaging centers conducting a key scan for inclusion in the study to ask them to help share info. • Form study Patient Committee to get feedback on recruitment tactics • Set mini-recruitment goals for sites (i.e. 3 PD before the annual investigators meeting) • Form a partnership with the VA system to get their sites to refer patients 20
Unique recruitment tactics to leverage MJFF as sponsor • Michael J. Fox image • Brand recognition of the foundation • Neutral, widely-recognized, non- traditional sponsor • Extensive existing networks for outreach 21
Study Progress to Date • 194 of 400 PD and 147 of 200 controls enrolled • Goal is to finish recruitment by early 2013 22
Reflections and Recommendations • Determine where your ideal subjects are. – How can you can get there? How can you convince others who are interacting with these subjects to share info? • Be creative – think outside the box. • Explore multiple approaches simultaneously- you never know what will work and it will require a multi- pronged approach to be successful • Pilot! Start small to test your assumptions and ideas and then expand the ones that work 23
Thank you! Questions? Contact us with questions: Claire Meunier at cmeunier@michaeljfox.org 24
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