WELCOME TO ATLANTA JANUARY 14, 1999

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Welcome to the RTOG Research Associate
Orientation Tampa February 2007
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PROTOCOLS
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Protocol Design

• Types of Studies
• Protocol Format
• Protocol Development and Activation
• Preparation for Study Participation

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Types of Studies

• Phase I
• Phase II
• Phase I/II
• Randomized Phase II
• Phase III
• Lab Correlates
• Cancer Control
• Randomized vs. Non
• Intergroup

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Phase I, II, I/II

• I Determine the maximum tolerated dose.
  Investigational drugs .
• II Response to treatment (extent of tumor
  reduction).
• I/II Early and late endpoints dose searching
  studies.

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Phase III Studies

• Randomized prospective comparison
• of experimental regimens.
• Larger number of participants (4000).
• Followed for a longer period of time.
• End point may be response duration
• and survival.

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Reason for Randomization

• Patients can be assigned to 2 or more treatment
  regimens.
• Minimizes bias and balances stratification
  factors (age, weight loss, stage of current
  disease).
• Provides the greatest credibility.

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• Laboratory correlates
• Cancer control
• Intergroup

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Study Classifications

• Single Blind
• Double Blind
• Single Arm
• Multiple Arm

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Protocol Format
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Sections of Protocol

• Schema
• Eligibility Check
• 1.0 Introduction
• 2.0 Objectives
• 3.0 Patient Selection

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Sections of Protocol

• 4.0 Pretreatment Evaluations
• 5.0 Registration Procedures
• 6.0 Radiation Therapy
• 7.0 Drug Therapy

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Sections of Protocol, Continued

• 8.0 Surgery
• 9.0 Other Therapy
• 10.0 Pathology/TRP Correlates
• 11.0 Patient Assessments

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Sections of Protocol, Continued

• 12.0 Data Collection
• 13.0 Statistical Considerations
• References
• Sample Consent
• Appendices

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Protocol Developmentand Activation
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Comprehensive Review Mechanism Group Strategy

• Concept review and feasibility survey
• Group review
• Internal review
• NCI review (generating a re-review by group and
  study chair)
• Activation
• Revisions

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RTOG Web Site

• http//www.rtog.org

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Preparation for Study Participation
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Preparation for Case Entry

• Review Eligibility Requirements (sect.3.0)
  -complete eligibility list
• -questions to RA at HQ prior to registration
• Review Required Studies Labs--did they occur
  within required time frame?
• Review Feasibility for Success--should this
  patient be entered on study?

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Registration Procedures

• Mandatory Web Registration Available 24 hours a
  day/7 days a week
• Intergroup Registration Fax Eligibility
  Checklist to 215-574-0300
• IMPORTANT REMINDERS
• Complete Eligibility Checklist
• Signed and Dated Informed Consent
• Patients must be registered prior to the start
  of any protocol treatment

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Go to RA Corner for User Authorization Form
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Confirmation of Web Registration

• Following a successful Web Registration you will
  receive
• Treatment Assignment and Case Number
• E-Mail Confirmation
• A0
• Patient Calendar
• Check carefully for errors

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Email Confirmation
From CONFIRMATION CONFIRMATION_at_rtog.org To
brenda_young Subject ACR New Case Registration
for Study No - 9998 and Case No
- 0034   Hello,   The Confirmation of New Case
Registration for the American College Of
Radiology Study 9998 Case 0034.Please Find the
attached A0 Patient Calendar HTML File.  
Thanks, ACR     Note This information E-mail
is Auto generated by the Clinical Server On Wed
Jan 14 124400 EST 2004 (Eastern Standard
Time).Replies will not be checked on this server,
so please send your Queries to HQ directly for
prompt response.  
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Calendars and Data Schedule

• Purpose
• Record / log forms
• Form description
• Changes to calendar
• Calendar extension

Jan 2006
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PURPOSE

• Verification of assignment
• case number
• Institution name / number
• Patient identification / number
• Calendar base date
• Timetable data / form submission
• Access to real-time calendars for all cases via
  RTOG Data Log In Center on website

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Example Hard Copy Calendar
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Example Web Calendar
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RECORD / LOG FORMS

• list of forms according to due date
• all forms are per section 12.0 of protocol
• each form requires a response

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ID / Description of Forms

• Form identification via two descriptors
  form title two letter ID code

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Patient Status

• Alive
• Dead
• Lost

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Patient Status

• Lost Cannot obtain patient status / information
  for
• gt 3 years V5
• Need to document all efforts to establish
  patients status.

• Alive data submission is as per calendar
• Dead data due prior to date of death becomes
  due Z1 remains due until response is received

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? QUESTIONS ?