Andrew G' Clair, Ph'D'

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The Important Relationship of Study Coordinators
with Pharma

• Andrew G. Clair, Ph.D.
• Director
• Medical Regulatory Services
• Pfizer Inc
• April 19, 2006

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Study Coordinators-Topics to Consider

• The role of the Study Coordinator (SC) in the
  development of new drugs
• The principles of ICH GCP
• Sponsor site visits
• Recruiting and retaining study subjects
• Managing and reporting adverse events
• Study documentation-collecting and reporting
  clinical trial data
• The FDA audit

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The Role of the Study Coordinator in the
Development of New Drugs

• The Study Coordinator
• Performs the bulk of the work at the study site
• Recruitment and retention
• CRF completion
• Offers insights on difficult issues
• What is impeding recruitment
• Inclusion/exclusion criteria
• Is pivotal in ensuring enrollment goals
• Drives study forward

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The Premise of ICH GCPs

• Ensures that the rights, safety and well-being of
  trial subjects are protected and their welfare is
  put ahead of the scientific research they have
  volunteered to participate in
• Ensure the data is credible as generated

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The Principles of ICH GCPs
The Investigator

• Informed Consent
• Records and Reports
• Progress Reports
• Safety Reporting
• Premature Termination
• Final Reports

• Qualifications
• Adequate Resources
• Medical Care of Trial Subjects
• IRB Communication
• Protocol Compliance
• Investigational Product
• Randomization/Unblinding

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Adequate Resources

• This means there is the potential for recruitment
  within the agreed upon recruitment period for the
  required number of suitable subjects
• There are an adequate number of qualified staff
  and adequate facilities to conduct the trial
  properly and safely
• All persons assisting with the trial are
  adequately informed about the protocol,
  investigational product and their trial-related
  duties and responsibilities

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IRB Communication

• Before trial initiation, there needs to be
• written and dated approval from the IRB
• written and dated informed consent
• consent form updates
• subject recruitment procedures (e.g., ads)
• A current copy of the Investigators Brochure
  should be provided to the IRB

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Protocol Compliance

• Deviations or changes from the approved protocol
  should only be done with agreement from the
  Sponsor and prior review and documented approval
  from the IRB for an amendment

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Investigational Product

• Records should be maintained of the product for
• Delivery
• Inventory
• Use by each subject
• Unused product disposition
• Records should include
• Dates
• Quantities
• Batch numbers
• Expiration date

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Informed Consent

• Should be obtained at the proper time not after
  a subject has been enrolled in the study

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Managing and Reporting Safety Reports

• The Study Coordinator should assure
• That all subjects report all AEs at each study
  visit
• -Captured on the CRF and monitored throughout the
  study
• All serious AEs are reported by the SC
  immediately
• All serious adverse events should be reported
  immediately to the Sponsor via fax or phone
• The immediate report should be followed promptly
  by more a detailed, written report

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Sponsor Site Visits

• In advance of a Sponsor site visit
• Have all study documents in good order
• Available for review
• CRFs complete and accurate
• Study Coordinator should make every effort to be
  available
• throughout a Sponsors visit
• Address questions
• Make corrections/clarifications

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Recruiting and Retaining Study Subjects

• Dependent on study and patient population
• Advertising budget/centralized advertising is a
  plus
• Some sites will offer to pay for transportation
  to and from site in order to promote retention
• Ideal Study Coordinator reaches out to colleagues
  or the
• community to promote study awareness
• Good patient care the most effective retention
  strategy
• If the subject believes there is an advantage to
  participating and they are treated well, there is
  great incentive in completing the study

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Study Documentation

• The SC maintains all data and documents for the
  study
• This includes regulatory documents, drug receipt,
  dispensing information, subject source documents,
  CRFs, IRB correspondence
• Site personnel documents (i.e., CVs and
  delegation of duties log) should be accurate and
  up-to-date
• The SC should report any significant study events
  (protocol violations, etc.) to the IRB
• Ensure that all information meets ICH/GCP
  standards and is organized and easily accessible
  to the Sponsor/auditor

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The FDA Audit

• The Study Coordinator
• Should work with the Sponsor to ensure that all
  documentation is available
• Should be forthright enough in asking for
  assistance from the Sponsor, when necessary
• -SC has a significant workload, as is, in
  screening, enrolling subjects, collecting study
  data and acting as the 1 liaison to the Sponsor,
  CRO, vendors, etc.

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Most Common Deficiencies in Study-Oriented Audits
Inadequate Consent Form Inadequate Drug
Accountability Protocol Nonadherence Inaccurate
Records Failure to Keep IRB Informed
56 25 26 21 13
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Most Common Deficiencies in Investigator Oriented
Audits
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Regulatory/Administrative Consequences Actions

• Clinical Hold
• Issuance of a Letter
• Untitled (old NOV)
• Warning
• Seizure of Test Articles
• Criminal Prosecution
• Consent Decree (restrictions)
• Disqualification
• Data (efficacy not allowed)
• Investigator
• Both

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• THANK YOU!