1. US Early Feasibility Studies (EFS)
A Medical Device Company Perspective
Why I Don't Conduct EFS in the US
Keith Dawkins MD FRCP FACC FSCAI
Global Chief Medical Officer
Executive Vice President
Boston Scientific Corporation

2. Conflicts of Interest Boston Scientific Corporation Employee
Stockholder

3. Disclaimer US Early Feasibility Studies (EFS)
A Medical Device Company Perspective
Why I Don't Conduct EFS in the US
This title was chosen by Ron Waksman MD, and does not reflect the views of Boston Scientific Corporation…!

5. ‘FDA recognizes the value of encouraging medical device innovation to address clinical needs and improve patient care, particularly when alternative treatments or assessments are unavailable, ineffective, or associated with substantial risks to patient safety. This guidance has been developed to facilitate the early clinical evaluation of medical devices in the United States under the IDE regulations, using risk mitigation strategies that appropriately protect human subjects in early feasibility studies…’

6. Impediments to Clinical Research
Regulations
Sponsor-imposed impediments to Clinical Research
Academic Institutions: impediments to Clinical Research
Health Systems & clinical practice sites: impediments to Clinical Research
Kramer JM: Clin Pharmacol Ther 2012;91:

7. Impediments to Clinical Research
Regulations
US Federal
Electronic records (21 CFR 11)
Human subject protections (21 CFR 50)
Financial disclosure by clinical investigators (21 CFR 54)
Institutional review boards (21 CFR 56)
Investigational new drugs and biologics (21 CFR 312)
IND safety reporting (21 CFR )
Sponsor obligations 21 CFR ;
Investigator obligations 21 CFR
Investigational devices (21 CFR 812)
Privacy laws (45 CFR 164)
US State
European Clinical Trials Directive
Other national regulatory authorities
Kramer JM: Clin Pharmacol Ther 2012;91:

8. Clinical Research Challenges
US Clinical Trial Enrollment Delays Worsen
Percent (%)
Source: CenterWatch Surveys of Investigation Sites

9. Current Clinical Research Environment
A Growing Proportion of Novice Investigators
Note: Experienced Investigators conducted at least one study in the prior year
Source: CenterWatch Analysis of FDA BMIS Database (2011)

10. Current Clinical Research Environment
The Increasing Proportion of Low-Volume Investigators
File Annually
File s Annually
File ≥5 1572s Annually
0.7%
Source: CenterWatch (2011)

11. Metrics for Successful Clinical Research
Clinical Expertise
Experience with Clinical Trials
Necessary Clinical Trial Infrastructure
Available Target Patient Population
Compliance
High Data Quality
Data acceptable for Regulatory Approval
Cost
Timeliness to FPI & Trial Completion

12. Conclusions
Effective Clinical Trial execution is judged by the most rapid negotiation of the numerous barriers inherent in navigating the country-specific regulatory pathway
Ultimately, speed to market defines commercial success
Many factors determine geographic selection for site participation and patient enrolment
If the US can be shown to be competitive (and a ‘fast’ FDA pathway for First Human Use or Feasibility Trials is only one element of the clinical trial paradigm), then Boston Scientific would welcome the opportunity of early domestic device evaluation