Lecture 8 Flashcards
1930s-1940s WWII
Nazi physicians conducted unethical experiments on concentration camp prisioners
Tuskegee Syphilis Study
A study in Macon county, Alabama to determine the full progression of Syhilis in humans.
last 40 years.
Henrietta Lacks (1951)
Had cancer, had a biopsy of cervical cancer tissue without her consent. Discovered she had immortal cells that never stopped growing and dividing (HeLa’s)
Used in 3 nobel prize winning studies, she nor her family knew about the cells until recently
Nuremberg Code
Requires voluntary, informed consent for participants in research
Helsinki Declaration
informed consent, responsibility to protect the patient over the science and particular assistance to vulnerable patiens
FDA
accountability in marketing of food and drugs and regulations regarding testing drugs in clinical trials
Clinical trials
any research project that prospectively assigns human subjects to intervention and comparison groups to study cause-and-effect relationships between a medical intervention and health outcome
Drug Discovery & Development
Researchers discover new drugs through
- new insights into a disease proccess
- testing of molecular compounds
- existing treatments that have unanticipated effects
- new technology
At this stage they are asking questions
Preclinical research
before testing in humans, the drug will be tested in vitro (cells in petri dish) or in vivo (animals models)
Clinical trials
Prior to beginning a clinical trial, a researcher must submit an application to the FDA with the following information:
- animal study data and toxicity
- manufacturing info
- clinical protocols
- data from prior research
- info about the investigator
Phase 1 clinical trials
study participants: 20-100 healthy volunteers w/ the disease/condition
length: several months
purpose: evaluate safety, dosage, and side effects
70% move to next phase
Phase 2 clinical trial
study participants: several hundred people w/ disease/condition
length: several months to 2 years
purpose: test effectivness and side effect
33% go on to next phase
Phase 3 Clinical trials
study participants: 300-3000 volunteers with disease/condition
length: 1 to 4 years
purpose: confirm effectiveness and monitor reactions; compare to other treatments
25-30% move to next phase
Phase 4 clinical trials
study participants: several thousands with disease/condition
purpose: provide any other infor, practice best use, confirm benefits
Drug review
once the drug is showing promise in the clinical trials, the researcher will apply the FDA to market the drug. Application must contain information including all data from preclinical research-all phases of clinical trials and -
Proposed labeling
safety update
drug abuse info
patent info
data from studies outside US
Directions for use
project manager
coordinates the team’s activites throughout the review process and is the primary contact for the sponsor
medical officer
reviews all clinical study info and data before and after the trial is complete
statistician
interprets clinical trial designs and data, and works cloesly with the medical officer to evaluate protocols and safety and efficacy data
Pharmacologist
reviews preclinical studies
harmakineticist
focuses on the drug’s absorption, distribution, metabolism, and excretion processes. Interprets blood-level data at different time intervals from cliical trials, as a way to assess drug dosages and administration schedules
Chemist
evaluates a drug’s chemical compounds. Analyzes how a drug was made and its stability quality control, continuity, the presence of impurities
microbiologist
reviews the data submitted, if the product is an antimicrobial product, to assess response across different classes of microbes.
Post-market drug safety and monitoring
Continuous monitoring and surveilance of a drug and its effect is important to maintain the highest level of safety possible for the population
Emergency Use Authorizations
EUS authority allows FDA to Help strengthen the nation’s public health protections against chemical, biological, radiological and nuclear threats including infectious diseases, by facilitating the avalibility and use of medical countermeasures needed during public health emergencies.
