Developing a Cancer Research Department

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Developing a Cancer Research Department
Texas Tumor Registrars Association Educational
Conference August 23, 2006
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Value of Research in Oncology

• Why Do Patients Participate in Clinical Trials?
• It provides an innovative treatment option
• It provides an opportunity for to receive an
  investigational drug after receiving and failing
  standard therapies
• To benefit medical knowledge so that treatments
  are continuously improved.
• To help future generations in our quest to cure
  cancer.

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Value of Research in Oncology

• Patients seek health care organizations that
  provide innovative trials
• Cancer patients participating on a trial and
  their physician investigators become a team in
  the fight to cure cancer and improve quality of
  life.
• Patients without cancer can contribute by
  participating in cancer prevention studies
• Value Cancer Center becomes partners with the
  community developing loyalty and positive praises
  to others positive image

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Benefits of Community-Based Research to Consider

• Best care for patients
• Provides a legitimate avenue for hope
• Keeps patients close to home
• Intellectual stimulation
• Facilities best practice
• Leadership development in cancer care
• Statistic 85 of cancer patients are treated in
  the community

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Definition of a Clinical Trial

• Scientific study that tests the effectiveness of
  a drug, treatment or medical device with
  patients.
• Trials consist of four phases, with the first
  three designed to gather information for the
  submission of a New Drug Application (NDA) to the
  Food and Drug Administration.
• The fourth phase addresses post-marketing studies.

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Phases of Clinical Trials

• Pre-clinical Basic research of new drug, device
  or treatment
• Phase I Safety and tolerance
• Phase II Efficacy for a specific population and
  disease define dose
• Phase III Establish safety efficacy with
  selected dose in broad sample
• Phase IV Monitors continued safety in large
  groups

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The Research Process

• The road to clinical research begins with basic
  science investigation of a hypothesis. Basic
  science research may include
• In Vitro tissue cultures and cell lines
• Molecular and cellular techniques
• In Vivo testing using animal models
• Initial chemical development of a compound

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Basic Research

• Pre-clinical research that is conducted to
  investigate the nature of a drug, device or other
  test article in order to obtain new knowledge.
• Knowledge gained through basic research may be
  put to practical uses through translational and
  clinical research.

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Translational Research

• The conversion or translation of findings from
  basic research into new therapies, information,
  resources, or tools that can be applied by health
  care providers to improve health outcomes.
• Phase I drug and device studies
• New diagnostic testing (micro-arrays,
  cytogenetics, devices)
• Prevention studies (healthy lifestyles, diet)
• Epidemiological tools

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Clinical Research

• Patient-oriented research
• Epidemiologic and behavioral studies
• Outcomes research and health services research

Source NIH Director's Panel on Clinical
Research
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Types of Trials

• Intramural
• Funding from the institutions foundation
• Extramural
• Industry-sponsored (drug companies)
• Government-sponsored (NIH, NCI)
• Foundation-sponsored
• Cooperative group
• Government-sponsored
• Large, Multi-institutional Oncology Groups
• (mostly phase III and phase II)
• (SWOG, ECOG, COG, MDACC, RTOG, NSABP)

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Funding Sources

• Industry
• Sponsors provide funding for above standard of
  care treatment costs, data management, research
  staff, IRB fees, and laboratory testing.
• Federal grants
• NCI and NIH funds include personnel, travel,
  supplies, and above standard of care costs
• Institutional grants
• According to institutions funding guidelines.
• Private foundations

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Components Required for Conducting Oncology Trials

• Adequate research staff investigators
• Facilities to house staff, perform patient
  visits, store regulatory documents, records, and
  drug accountability
• Access to laboratory, radiology, radiation,
  pharmacy, and treatment services
• Access to IRB (local or central)
• Access to Tumor Registry for study feasibility
  and patient identification
• Access to other support services

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Key Players Needed to Conduct Oncology Clinical
Trials

• Experienced Investigators
• Clinical Research Coordinators RN
• OCN, CCRC preferred
• Clinical Research Associates data managers,
  CCRC preferred
• Pharmacist(s) and pharmacy
• Lab Techs to provide laboratory services
  (specimen processing and shipping)

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Principal Investigator

• Medical license to practice in State
• Board certification in speciality preferred
• Updated CV or biosketch every 2 years (signed and
  dated)
• Completion of Certification in Human Subjects
  Research in compliance with NIH
• Compliance with FDAs Code of Federal Regulations
  concerning human subjects research
• Takes responsibility to conduct trial at site and
  oversee trial according to regulations
• Participates in site initiation and monitoring
  visits
• Reviews adverse events and safety reports

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Sub-investigators

• Medical license to practice in state
• Board certification in speciality preferred
• Updated CV or biosketch every 2 years (signed and
  dated)
• Completion of Certification in Human Subjects
  Research
• Compliance with FDAs Code of Federal Regulations
  concerning human research
• Accrues and treats patients on trials

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Clinical Research Coordinator-RN

• RN license
• Prefer membership in Oncology Nursing Society
  and certification as Oncology Nurse Clinician
  (OCN)
• Prefer membership in SOCRA or ACRP with
  certification as CCRP or CCRC
• CRC-RN responsibilities include study start-up,
  subject screening and enrollment, testing and
  procedures according to protocol, toxicity
  assessment, identification of adverse events.

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Clinical Research Associate

• Data manager and regulatory document control
• Prefer Associates degree or higher
• Prefer membership in SOCRA or ACRP with
  certification as CCRP or CCRC
• CRA responsibilities include study submission and
  correspondence with IRB and sponsor, study
  start-up, subject screening and enrollment,
  scheduling procedures according to protocol, data
  management from sources documents, adverse
  event reporting, preparation for monitoring
  visits and auditing.

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Research Pharmacist

• Registered pharmacist, preferred experience in
  oncology and research drug accountability
• Pharmacist participates in site initiation and
  agrees to manage investigational drugs include
  receiving, dispensing, preparation, and disposal
  according to protocol
• Pharmacy charges should be included in research
  budget (study start-up, dispense and preparation
  fee)

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Financial Considerations for Oncology Trials

• Investigator(s) and institutions will need to
  evaluate costs to conduct trials
• CRC-RN and CRA salaries
• Fringe benefits
• Travel to meetings
• Facility costs
• Supplies and communication
• Trial selection goal is to balance types of
  trials in order to break even or achieve profit
  to reinvest into the research program

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Financial Considerations for Oncology Trials

• NCI Support for cooperative group trials
• 1200 to 2000 per patient
• Only covers partial support of CRA / CRC
• Subsidize the cost of data management
• Pharmaceutical Industry Support can help
  subsidize data management costs but requires
  commitment from investigators to achieve accrual
  goals and requires significant CRA and CRC
  support
• Achieving a balance between NCI and Industry
  Trials will result in well-rounded cancer
  research department that will at a minimum, break
  even.

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CRA Full-time Workload

• NCI Sponsored trials
• 1.0 FTE CRA can manage 10-20 trials and accrual
  of 20-30 patients per year
• Industry Sponsored phase II and III trials
• 1.0 FTE CRA can manage 5-10 trials and accrual of
  20-30 patients per year
• Industry Sponsored phase I trials
• 1.0 FTE CRA can manage 2-5 trials, 10-20 patients
  per year

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Other Considerations

• Industry sponsored trials require frequent
  monitoring visits that requires space, computer
  access, phone access, and chart review (Medical
  record and/or electronic record access)
• Space requirement for case report forms and
  regulatory binders is significant including a
  location for long-term storage

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Institutional Offices that Support Cancer
Research Department

• Grants Administration Office
• Submission, and tracking of grant awards
  maintains investigator biosketches, other
  support, institutions data
• Research Compliance Office
• (Institutional Review Board, tracks Research
  Certification, performs internal audits,
  addresses compliance issues)
• Research Contracts and Fiscal
• (Budget preparation, contract review, invoicing,
  tracks fiscal components of study management)
• Biostatistics
• Biomedical Communications
• (Illustrations, Photography)

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Initiating a Clinical Trial Feasibility

• Perform feasibility assessment
• Use Tumor Registry to determine the number of new
  cancer cases for the diagnosis in the trial being
  considered
• Evaluate if adequate research staff is available
  to support the trial
• Evaluate if other services are available to
  complete the trial requirements (lab, equipment,
  procedures)
• Evaluate if eligibility requirements may exclude
  high percentage of potential patients
• Evaluate if payment from sponsor is adequate to
  cover costs

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Initiating a Clinical Trial Pre-study Site
Visit

• Confidential Disclosure Agreement (CDA) is
  completed by PI
• PSSV is conducted by sponsor
• Sponsor tours facility including where regulatory
  binders/CRFs will be stored, pharmacy, lab,
  treatment area
• Meets research staff including principal
  investigator

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Initiating a Clinical TrialSite Initiation

• After site is selected and feasibility in
  completed, regulatory documents are submitted to
  IRB for review and approval protocol, consent,
  investigators brochure, advertising materials,
  etc.
• Budget negotiation and clinical trial agreement
  is completed
• Sponsor conducts SIV and reviews protocol and
  trains research staff on completing CRFs

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Subject Screening

• Potential subjects are identified through
• Investigators
• Tumor registry
• Disease-specific team meetings
• Outside physician referrals
• Self-referrals
• Advertising
• www.clinicaltrials.gov
• Cancer Research Departments website

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Study Accrual Goals

• Investigator and study team works to achieve
  accrual goals
• Address barriers to accrual with sponsor
• Key to Success is achieving accrual goals which
  maintains balanced workload for CRA/CRC staff and
  adequate payment to cover costs of conducting
  trial.

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Oncology Research Today

• Shift from new chemotherapies to biologic
  therapies (immunotoxins, antibodies, protease
  inhibitors, vaccines, gene therapy)
• Individual DNA analysis of patients to identify
  genes linked to cancer types
• DNA analysis to individualize therapy
• Alternative therapies (mindful relaxation)

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Biologic therapies

• Antibodies Bind to specific antigen on surface
  of tumor cell and initiates cell death Avastin,
  Cetuximab, Rituxan, Herceptin

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DNA Microarrays

• Many studies are requiring submission of tumor
  blocks, marrow or other tissues for DNA
  Microarray studies
• Goal is to identify gene(s) that correlate with
  the cancer or risk level of cancer

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Questions?

• Lisa Reeve, MHSM, CCRC
• Director of Cancer Research Operations
• Scott White Cancer Institute
• lreeve_at_swmail.sw.org