Clinical Trials Flashcards
First agency to conduct a clinical trial
Navy
A research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes
Clinical Trial
A systematic investigation, including research development, testing and evaluation, designed to develop or contribute to generalizable knowledge
Fundamental research
The study of health and illness in people
Clinical research
3 main types of clinical research
- patient oriented research
- epidemiological and behavioral studies
- outcomes and health services research
A research project to test the safety or efficacy of a drug, device or other treatment; must develop or contribute to generalizable knowledge
Administering the intervention
Clinical trial
4 phases of clinical trial
1) tests the safety of medication and treatment on a small group of people
2) continues safety and effectiveness testing with a slightly larger group; participants are afflicted with disease/condition they are trying to treat
3) studies safety, effectiveness and dosing of treatment on hundreds to thousands of people; double-blinded study (patients and providers)
4) intervention is already approved. studies long term effectiveness, comparing new treatment to standard treatment
Recipe for the study
Establishes the primary outcome; determines feasibility and budget; establishes patient inclusion/exclusion; verifies how data will be collected and managed
Protocol
ICF
Informed Consent Form
Discussion …review…concerns…time…signatures obtained
Essential elements of informed consent (x8)
1) research description
2) risks
3) benefits
4) alternatives
5) confidentiality
6) compensation
7) contacts
8) voluntary participation and withdrawal
IND
Investigational New Drug
Experimental drug intervention in clinical trial
Investigational New Drug (IND) types (x3)
new intervention (drug usually) tested in a clinical trial. Must have IND FDA approval before phase 1 CT begins. 3 types:
- investigator IND: submitted by physician who initiates and conducts study
- Emergency IND: allows FDA to authorize use of experimental drug in emergency situation
- Treatment IND: submitted for experimental drugs showing promise in clinical testing for serious if immediately life threatening conditions
IDE
Investigational Device Exemption
AE
Adverse Event
Any type of health issue that occurs in a clinical trial participant
Very common in clinical trials; may or may not be related to intervention
SAE
Serious Adverse Event
5 types of Serious Adverse Reaction (SAE)
1) death
2) a life threatening adverse event
3) inpatient hospitalization or extension of existing hospitalization
4) persistent significant incapacity or substantial disruption
5) birth defects
Nuremburg Code
Applies to all human subs research; first intl standard for protection of human subs
10 points to this code - introduces concepts of informed consent, voluntary withdrawal, researcher needing to stop study if he/she felt was dangerous
ICH GCP
International conference on Harmonisation-good clinical practice
Belmont Report
Commissioned in 1974 by the National Research Act after the news of the Tuskegee study came out
3 parts of Belmont Report
1) respect for persons
2) beneficence
3) justice
45 CFR Part 46
1991 Common Rule
Established 4 major subparts
15 fed departments and agencies adopted the common rule
Common Rule major subparts (x4)
Subpart A - federal policy
Subpart B - additional protections for pregnant women, human fetuses, neonates
Subpart C - additional protection for prisoners
Subpart D - additional protections for children
OHRP
Office for Human Research Protections
IRB
Institutional Review Board
Main job is to protect human subjects; also assess whether a group of individuals is a vulnerable population
RCT
Randomized Control Trial
Designed to isolate and confirm
OSHA
Housed in the Department of Labor
The Occupational Safety and Health Administration (OSHA /ˈoʊʃə/) is a large regulatory agency of the United States Department of Labor that originally had federal visitorial powers to inspect and examine workplaces.[2]: 12, 16 Congress established the agency under the Occupational Safety and Health Act (OSH Act)
OSHA’s mission is to “assure safe and healthy working conditions for working men and women by setting and enforcing standards and by providing training, outreach, education and assistance”.
Employees are to be provided with place of employment free from recognized hazards
Occupational Safety and Health Act (OSHA) of 1970
Occupational Safety and Health Administration (OSHA) requirements (x3)
- employees should be ensured work environments free of known hazards; or at least alerted of hazards
- employers must provide PPE
- employer must provide a respiratory protection program
- includes participants afflicted w disease
- 100-300 participants
- subjects are randomized
- adds blinded control group (placebo)
- focus = efficacy
Phase 2 clinical trial
Most trials end here bc determined intervention is not effective enough to continue
mechanism by which patient data is collected and submitted to sponsor
case report form (CRF)
PII
personally identifiable information
can be used to distinguish or trace individual’s identity
protected by HIPAA
