Investigators and Clinical Trials

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Investigators and Clinical Trials

• Kiat Ruxrungtham
• Professor of Medicine
• Chief, Allergy and Clinical Immunology Division,
• Department of Medicine, Chulalongkorn University,
  and
• HIV-NAT, Thai Red Cross AIDS Research Center

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Clinical Trial Why Who
Investigators
Sponsor
IRB/IEC
SUBJECTS

• Regulators
• Monitors
• Health Authorities

New Treatment New Vaccine New Strategy

• Improve human well being
• QOLs

in a timely manner
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Good Clinical Trial
Good Clinical Practice GCP
S Scientific valid E Ethically oriented A
Accuracy T Traceability
Good Laboratory Practice GLP
To find a New drug or New Rx regimen or Strategy
or Vaccine Better efficacy, less toxic, less
expensive, better compliance, prevention of
infection
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What does a clinical trial require ?
GCP GLP GMP

• Eligible subjects
• Investigators
• Regulatory IRB, FDA , custom
• Speed timely to finish
• Quality
• Retention rate
• Traceability

Effective Management
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Speed Why is it so important ?
Recruitment deadline
Recruitment time Enrolled number
Protocol review IRB approval FDA Custom Site
preparation
Competitive enrollment
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How to compete on the Speed for clinical trials

IRB
Prevalence Incidence
Time to approval
Feasibility Recruitment rate
Investigators
FDA Custom
Study drug importation
Great team
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How to compete on the Quality of clinical
trials
Monitors
Investigators
GCP GLP
Effective Management
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Different Types of Clinical Trials in Thailand

• Sponsor-initiated trials
• Pre-launch protocol
• Scientific-based protocol
• Local protocol
• International protocol
• Multi-national protocol

• Self-initiated trials
• With no sponsor
• With some sponsor from government sectors or
  organization
• With pharmaceutical industrysponsor

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Types of Investigators

• No experience in GCP-GLP but eager to learn and
  willing to perform
• GCP-GLP experienced but too busy to perform
  GCP-GLP trial
• One-man show
• A small but efficient teamwork part-time vs full
  time assistants
• A clinical trial unit

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Different Settings of Investigators

• One man show
• Spare-time researcher
• Part-time researcher
• Full-time researcher
• A small team, all part-time staffs
• A small team with at least one full-time staff
• A clinical trial unit with many full-time staffs

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What a Clinical Trial Unit looks like ?
Team
Leader (Director, P.I.)
MD, RN/RA, MT/MTA Statistician, DM etc.
Commitment ? Scientific ?
Clinical Trial Unit
Infrastructure
Administration
Funding
OPD / IPD - n ? Lab. facility GLP Storage
system Security back up
Personels Collaboration Financial Space Time
frame QA/QC
Industry Research Grant Government
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Roles and Responsibilities of Investigators

• 1. Prior to the study
• 2. During the study
• 3. After the study

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Good Clinical Trial
Good Clinical Practice GCP
S Scientific valid E Ethically oriented A
Accuracy T Traceability
Good Laboratory Practice GLP
To find a New drug or New Rx regimen or Strategy
or Vaccine Better efficacy, less toxic, less
expensive, better compliance, prevention of
infection
14
Encouraged Roles of Investigators

• Keep high profile in the field /specialty
• Investigators must play much more roles on the
  early phase study protocol development
• Development design, endpoints etc.
• Input critical idea, feasibility, foresee
  problems
• Ensure the speed and quality of the study
• Active participation on any major study-related
  meeting, teleconf. (TC)
• Active involving in discussion results, abstract
  and manuscript drafting
• Perform the best on the result presentation if
  being invited

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Expanding for more qualified investigators /sites

• GCP Training , Workshops
• Guest lectures, symposiums
• On-the-job training included them into the
  trial