Guest Speaker Natalie Reed

• Goals of Clinical Trials
o Safety above all else
o Collect data to sufficiently support primary objective
• Have to have a question that can be answered with your study
o Collect Adverse Events to detail potential side effects of final drug marketed to public
• Preclinical Research
o Long and arduous process when compound in question is tested in various laboratory assays including those conducted in laboratory animals … species depending on which system of humans is desired to be researched
• Eg. Porcine (pig) for human cardiovascular system; Rodent for human immunological system
• IND application
o Investigational New Drug Application
• The form filed with the FD Administration
• Phase I
o In-patient
o Normal Subjects
o Ensure Safety
o Establish Maximum tolerated dose
• Give different levels to different people and when it makes them sick goes to the one before that and say that’s the most
• Phase II
o Out-patients
• Can be an in-patient trial
o Disease state patients
• First time it will go into patients with the actual disease
o Ensure safety
o Ensure efficacy
• If you take drug exactly as prescribed and it works = efficacious
o Establish dose levels for phase III
• How much drug, under maximum tolerated dose, will it take to treat the disease
• Phase III
o Disease state subjects
o Wide geographic distribution
o New Drug Application
• The process of submitting all research data from Pre-clinical through Phase III data for FDA’s review
• Can take a year or two
• For each single day that a drug is not on the market the pharmaceutical company can lose about 2 million dollars
• Phase IV
o NOT required – but can be handy
o Aids in seeding the market
o Surveillance for Adverse Events
• Making sure the drug is still safe
• Checking for other AE that could occur
• The Sponsor
o Holder of drug patent
o Determine the research questions
• Or can kick it out to another company
o Write the protocol
o Select the doctors to conduct research
o Responsible to communicate with FDA
• Institutional Review Board (IRB)
o Oversight of study procedures at site
o Responsible for reviewing study wide safety information to assure the continued safety of local subjects
o Can require that a local study site change information given to subject
o FDA website
• Contract Research Organization (CRO)
o Provide services to the sponsor/site
o Site selection and start up process
• A lot of paper work – contracts, submissions to IRB, documents for collecting data
o Site initiation and monitoring
o Data collection and analysis
o Study site closure
o Document preparation for archival at sponsor
• Every sheet of paper that has to do with a study has to be kept for a minimum of 15 years after the last drug submission
• The Site(s)
o Principal investigator and staff
• Doctor, nurses, etc.
o Recruit subjects
o Inform subjects of risks and benefits
o Ensure safety
o Follow clinical guidelines
• The Subjects
o Absolutely essential to research
o Provide informed consent
o Meet inclusion/exclusion criteria
o Follow visit schedules and procedures
• If not, deviation - legal
o Provide essential data
• Natalie Reed got hired based on her knowledge of clinical research not on her education because she currently doesn’t have her Master's in Clinical Research – in process (corrected by DxRR. You DON'T need an MD to do clinical research, and that's NOT the kind of degree Natalie's working on.
• Did a research job out of college and gained all of the experience that she needed even though the pay was terrible

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