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Site Identification and Patient Recruitment and Retention – A Perfect Union - Tom Macek, Takeda Global Research and Development
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Site Identification and Patient Recruitment and Retention – A Perfect Union - Tom Macek, Takeda Global Research and Development

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Tom Macek, Takeda Global Research and Development - Speaker at the marcus evans Evolution Summit 2012, held in Wheeling, IL, April 30-May 2, 2012, delivered his presentation entitled Site …

Tom Macek, Takeda Global Research and Development - Speaker at the marcus evans Evolution Summit 2012, held in Wheeling, IL, April 30-May 2, 2012, delivered his presentation entitled Site Identification and Patient Recruitment and Retention – A Perfect Union

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  • 1. Site Identification and Patient Recruitment and Retention –a perfect union f t iTom Macek, PharmD, PhDSenior Fellow, Clinical SciencesTakeda Global Research and Development
  • 2. Factors that determine study success• Assuming a drug or product is safe and effective, the following are critical ▫ Appropriate p pp p patient recruitment ▫ Appropriate site selection ▫ Appropriate subject participation (retention)
  • 3. Determinants of quality q y sites Qualitypatients participation
  • 4. Factors that determine study success• Interdependence of these factors ▫ Negative impact of speed on quality• Difficult challenge by sponsors to determine performance of each ▫ Especially during conduct of ongoing studies that may be double blind ▫ Often – quality only known or assessed at end of study ▫ U ili i metrics or methodologies to asses quality Utilizing i h d l i li in ongoing study
  • 5. Sponsor pressures impact quality• Internal pressures of sponsor ▫ Expectations of management ▫ Realistic timelines ▫ Unknown negative• External pressures of sponsor p p ▫ Expectations of investors ▫ Expectations of patients and advocacy groups ▫ Competing competitor programs or products
  • 6. Managing internal and external pressures• Common methods to manage these pressures within a clinical study ▫ Add more sites ▫ Loosen Inclusion/Exclusion criteria ▫ Conduct more studies With limited investment prior to Phase 3 ▫ Enhanced recruitment and retention measures ▫ Others?
  • 7. General issues for consideration• What constitutes quality within a study?• Is a quality study only defined by positive results?• How to define quality of these factors?• What subjective or objective measures do we utilize for each factor
  • 8. General issues for consideration• What ongoing (during study) measures of performance can be utilized• How to utilize novel tools of patient recruitment and retention• Are measures of quality dependent upon therapeutic area? p ▫ Example - is the use of central monitoring of patient ratings by PI (in psychiatry/neurology) enhancing ability t d t t signal? h i bilit to detect i l?
  • 9. Selecting appropriate sites for a study• What are subjective measures that are utilized in identifying appropriate sites? ▫ Are positive sponsor-CRO-PI relationships sponsor CRO PI important to ensuring quality?
  • 10. Selecting appropriate sites for a study• What objective measures are utilized for site selection? ▫ Past performance – how to quantify quality Is rate of enrollment appropriate measure of q pp p quality? y What measures of quality could be utilized to asses site performance? Metrics of site training Placebo versus active control ▫ Operational measures of performance Are number of queries or other operational measures a true measure of site performance? ▫ Other methods?
  • 11. Utilizing appropriate recruitment measures• What common methods do we utilize for patient recruitment? ▫ How do these methods ensuring that the patients recruited are appropriate for the study? pp p y ▫ What are the pros/cons of advertising or using referral networks for study recruitment? ▫ How can social networking or other technologies be utilized to enhance patient recruitment?
  • 12. Utilizing appropriate retention measures• Is patient retention a surrogate of quality? ▫ Are there any instances in which patient retention may be a hindrance to quality? Is it possible to encourage patient retention to a point in which it has a negative impact on quality? ▫ What are the motivating factors to patients to remain in study? Can financial or other incentives be detrimental to study quality? ▫ What methods or techniques can be utilized to help ensure that the appropriate patients are participating in your study?
  • 13. Determinants of quality q y sites Qualitypatients participation

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