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PCL102 test 2 > clinical trials > Flashcards

clinical trials Flashcards

1
Q

who conducts clinical trials

A
  • the company developing the drug
  • 30% of the time at universities and hospital research institutes
  • 70% of the time private clinical research organizations
  • principal investigator involved (medical doctor with lots of expertise in the area)
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2
Q

how do you participate in a clinical trial

A
  • contact your family doctor
  • call the site directly
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3
Q

telephone interview in clinical trial

A
  • goal is to see if you are eligible to partcipate
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4
Q

screening visit in clinical trial

A
  • asked if you want to enter the trial
  • you will receive information packet
  • sign a consent form
  • talk to a trial nurse
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5
Q

design of phase 1 clinical trials

A
  • first-in-human
  • dosing is guided by preclinical animal studies and multiplied by a safety factor
  • test doses are in ascending order
    • single ascending dose study
      • tests one dosage level once
    • multiple ascending dose study
      • tests one dosage level over many days
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6
Q

whos in a phase 1 clinical trial

A
  • healthy volunteers (exception is cancer drugs)
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7
Q

phase 1 research questions

A
  • what doses can be tolerated
  • what doses are safe
  • how does the drug move in the body (absorption, distribution, metabolism, elimination)
  • these results guide the dosing in phase 2
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8
Q

how do you tell if a drug is safe

A
  • clinical signs (how someone feels)
  • bio markers
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9
Q

what is a bio marker

A
  • “a characteristic that is objectively measured and evaluated as an indicator of normal biological processes, pathogenic processes, or pharmacologic responses to a therapeutic intervention”
  • “any substance, structure, or process that can be measured in the body or its products and influence or predict the incidence of outcome or disease”
  • indirect markers of internal state
  • tools used to decide whether or not a drug is having an effect
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10
Q

examples of biomarkers

A
  • blood pressure
  • temperature
  • Cholesterol level
  • medical image/scan
  • level of virus
  • DNA test
  • pharmacogenetic test
  • lung cancer breathalyzer test
  • drug concentration in urine
  • blood sugar level
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11
Q

adverse events (AEs) and serious AEs

A

adverse event
- any undesirable experience associated with the use of a medical product in a patient

serious
- subset of adverse events
- should be reported to FDA
- death
- life-threatening
- hospitalization
- disability or permanent damage
- congenital anomaly/birth defect
- required intervention

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12
Q

pharmacokinetic testing in phase 1

A
  • frequent blood and urine tests to measure concentration in bodily fluids
  • gives an indication of where the drug is moving, and how quickly it is being eliminated
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13
Q

safety in phase 1 clinical trials

A
  • generally safe
  • always a level of risk in first-in-human trials and the precise level of risk is unknown
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14
Q

benefits of participating in a clinical trial

A
  • becoming among the first to benefit in an experimental therapy is effective
  • having your health monitored more often
  • being a part of a process that develops new drugs for other patients
  • altruism (might not help you directly, but might help others)
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15
Q

risks of being on a clinical trial

A
  • no guarantee of personal benefit
  • side effects
  • having to stop other medications that are working well
  • not being eligible for other trials in the future
  • not knowing who is receiving the experimental drug
  • making changes in lifestyle
  • potential for stigma or discrimination
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16
Q

inclusion criteria

A
  • ensure that relatively similar people take part in a trial
  • they must possess the criteria for the trial
17
Q

exclusion criteria

A
  • protects people who might be harmed by the drug study
  • people with active infections
  • pregnant women
18
Q

randomization

A
  • you are assigned randomly to a study group
  • you may have to wait to start
  • during this waiting period your health is observed/monitored
  • before starting the investigational drug, you may be asked to stop taking a medication and wait for a period of time (lets the body get rid of medications, avoid potentially harmful drug-drug interactions
19
Q

treatment period

A
  • the length of time that the investigators plan to have you on a treatment before they evaluate whether it works
20
Q

follow up visits

A
  • regular visits at the clinic
21
Q

end of study

A
  • the study ends when ALL participants have completed the drug treatment
22
Q

qualities of a good biomarker

A

sensitivity
- the fraction of persons with disease characterized as sick by the test

specificity
- the fraction of persons without disease characterized as healthy by the test

  • bio markers are imperfect and have <100% sensitivity and <100% specificity
23
Q

placebo

A

placebo
= the drug-a[[eraing substance

placebo effect
- a combination of physiological and psychological effects related to anticipation

24
Q

what are your responsibilities during the trial

A
  • understand the rules of the trial
  • follow the rules
  • keep appointments
  • follow the drug schedule
  • if you dont follow rules, you will be withdrawn from the trial
25
Q

your family doctors responsibilities

A
  • your health will be monitored at the trial site but you should continue to see your doctor for your overall health
  • it isnt ethical for doctors to take over the medical care of trial participants
  • to avoid repeating medical tests, family doctors and site investigators communicate
26
Q

what happens after the trial

A
  • exit interview
  • you MAY be told what treatment you were recieving
  • double-blind trials arent revealed until EVERYONE has completed the trial
  • recieve results

PCL102 test 2 (7 decks)

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