medical device consultants, inc. investing in a clinical program: advice in a challenging economic...

Medical Device Consultants, Inc.

Investing in a Clinical Program: Advice in a Challenging Economic Time

MassMEDIC Medical Device Clinical Trials Update June 19, 2009

Presented by:

Michael Feldstein, VP and Principal Biostatistician

2June 19, 2009Medical Device Consultants, Inc.

Introduction

Economic downturn has put increased pressures on medical device companies to curtail spending

Clinical trials can be very expensive


Regulatory Considerations:Pre-IDE Meetings – a no-cost (almost) opportunity

Non-binding, informal Opportunity for early collaboration Meet before significant preclinical work

or clinical studies Confirm device classification,

regulatory pathway Address questions related to preclinical

testing, clinical trials, endpoints


Other Considerations

Will the study be NSR (non-significant risk) or will an IDE be required?

When the product is cleared, what will the reimbursement be?


Other Considerations (continued)

Take FDA “suggestions” seriously Balance between urgency of timeline

and thoroughness of planning and execution

Right First Time Collaboration vs. confrontation


The Scope of the Clinical Program –Time and Cost

What is the likely cost of the clinical program?

What is the likely duration of the program? How prepared are you to fund the program

(expenditure of money over time)? Does your board/investor(s)/company

understand:1. The probable timeline?2. What could go wrong?3. Costs if something goes wrong?


Costs for Clinical Trials: Where does the money go?

CRO Hospitals/Clinics/Investigators (per

patient and overhead) Subjects (possibly, for expenses and

inconvenience) Liability Insurance


Costs for Clinical Trials: CRO Statistical Input Protocol development/review Case Report Form development (and

subject binders) Study Handbooks for Investigative

Sites Informed Consent Document Find/Qualify Investigative Sites Statistical Analysis Plan


Costs for Clinical Trials: CRO

Site Initiation Visits Routine Monitoring Visits Close-out Visits



Project Management Study Coordination (with sponsor and

sites)



Develop database/data entry screens Develop data management plan Data Entry Data Management



Routine administrative reporting (study progress)

Interim statistical analysis (if applicable) Final statistical analysis Statistical report of Clinical findings (per

statistical analysis plan for insertion into Regulatory submission)

Safety Reporting (MedDra Coding, etc.)



On-going consultation (statistics, regulatory)

Appearances at FDA (on sponsor’s behalf)

Meetings (DSMB, CEC, special meetings)


How can a Biostatistician help?1. Is the sequence of studies in the program

mapped out?2. Any useful human data available (safety

and/or effectiveness)?3. What are the relevant study endpoints

(that match the regulatory strategy)?4. Is there any controversy about how

endpoints are measured?5. Are the endpoints clinically “relevant” and

intuitive?6. Has a clinically meaningful outcome

(“success”) been defined?


More help

7. What is the best study design?8. What sample size is needed for the

chosen design?9. Does the sample size meet the

cost/time constraints?


Rules of Thumb for Clinical Studies/Trials

1. They always cost more than expected

2. They almost always take longer than expected

3. They require constant attention and discipline


What are the Riskiest Things to do Yourself?

Study monitoring Data management


Critical Good Clinical Practice Requirements

21 CFR outlines the regulatory requirements (various parts)

Two key elements of the regulations address study monitoring and data management

Various guidance documents


Study Monitoring Sponsor can contract out but cannot

delegate this responsibility to a third party

Competent monitoring is critical to study success (a PMA can be stopped in its review tracks by BIMO even before the PMA is reviewed)

Sponsor needs to carefully read all monitoring reports in real time and act as necessary to bring matters into compliance


Data Management

Data management practices must conform to the regulatory requirements

Briefly: if you can’t keep track of and store every single keystroke in an electronic data base, the system is not in compliance with the regulatory requirements


How to Decide What to Outsource? Review and understand all applicable regulatory

requirements Evaluate your current staff for proven experience with the

necessary tasks Define the “gaps” and decide if hiring/buying makes sense Decide if you can objectively execute a task (e.g.

monitoring)- danger: pandering to/coddling investigative sites and investigators, tolerating study protocol deviation, tolerating poor performance

Your goal is to make decisions that eliminate bias and any appearance of bias throughout the entire clinical process


Thank You

For additional information:

Michael FeldsteinVice President & Principal [email protected](508) 643-0434

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