Quiz 8 BTEC 3317

What is not associated with the first “clinical trial” on the effects of certain chemicals on human health?

 

Led to a law which prohibited interstate transport of unapproved drugs

 

The group of volunteer trial participants are known as the Poison squad

 

Findings contributed to passage of the Pure Food and Drug Act of 1906

 

The clinical investigation was not supervised by a licensed physician

 

The safety of the food preservatives were not tested in animals prior to testing in humans

The clinical investigation was not supervised by a licensed physician

What was the first law that required drug developers to demonstrate by way of clinical trials, that an investigational drug is both safe and effective in humans subjects prior to marketing approval?

 

Pure Foods and Drug Act of 1906

 

Biologics Control Act of 1902

 

Hatch-Waxman Act of 1984

 

Kefauver-Harris Amendments to FFDCA in 1962

 

Drug Importation Act of 1848

Kefauver-Harris Amendments to FFDCA in 1962

What is not true of an Investigational New Drug Application?

 

IND application is also known as FDA form 1571

 

The primary goal of the IND is to demonstrate to FDA that the new drug and proposed trials are designed to minimize risks to trial participants

 

After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start

 

IND approval will allow legal movement of unapproved drugs between states and into the US

 

IND requirements are found in CFR21 Part 312

After IND filing to the FDA, there is normally a 60 day wait period before the clinical trial can start

An IND is not filed to:

 

Test an already approved drug for a different indication in humans

 

Inform the FDA of a change in the location of an animal testing site.

 

Test a drug with a previously approved active pharmaceutical ingredient but in a higher strength formulation

 

Test a drug with a previously approved active pharmaceutical ingredient but in a new dosage form

 

Test a drug with an new active pharmaceutical ingredient in phase I human clinical trials

Inform the FDA of a change in the location of an animal testing site.

An IND submission to the FDA may not be required if:

 

An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.

 

An approved breast cancer drug will be tested for ability to treat liver cancer

 

A once a day, higher strength of an approved gastric efflux drug will be tested

 

An intravenous formulation of a drug will be tested in an oral dosage form

 

Two approved drugs for pain will be combined in one capsule

An individual decides to test if Ivermectin will protect himself from coronavirus, when the drug is not approved for coronavirus treatment.

An IND submission to the FDA requires information in 3 major areas. What information is not included in those 3 areas?

 

Study protocol for clinical testing in human subjects

 

Chemical description of the drug, the manufacturing process, and controls

 

Pre-clinical animal toxicity results

 

Proposed label and packaging information and design

 

Available data from earlier human studies

Proposed label and packaging information and design

An IND includes details on the plan for clinical testing. What information may not appear in the study plan for clinical testing?

 

Qualifications of clinical investigators

 

A science-based justification for testing in humans

 

Commitment to obtain informed consent from subjects

 

Professions of the test subjects

 

Description of possible risks to subjects and strategies for protection of subjects

Professions of the test subjects

One objective of clinical trials is to determine what the body does to the drug or pharmacokinetics. What is not part of pharmacokinetics?

 

If the active ingredient is mostly being excreted such that the amount absorbed is not enough to be effective

 

How much of the API in an inhalable drug is absorbed by through the lungs

 

How effectively the drug is distributed to target cells or tissues, like a brain cancer drug effectively reaching the brain.

 

How much elevation in activity in liver enzymes is observed when taking the investigational drug

 

If the active ingredient of the drug is being broken down in the liver to less active or even toxic forms

How much elevation in activity in liver enzymes is observed when taking the investigational drug

In which trial design are patients assigned to 2 treatment groups where the details of who among the patients get the investigational drug and who gets the placebo are known to the clinical investigator but not to the trial participants?

 

Single group design

 

Randomized open design

 

Parallel blinded design

 

Parallel double-blind design

 

Parallel open-label design

Parallel blinded design

What does not apply to the different phases of clinical trials?

 

In Phase II of clinical trials, the efficacy and safety of the investigational drug is normally first tested in individuals (up to a few hundreds) who have the condition being treated.

 

In Phase I clinical trials, the safety or toxicity of the drug is mainly tested in a small group of normally healthy individuals

 

A phase IV study is sometimes conducted to demonstrate possible superiority against a competitor drug

 

In phase III trials is where the maximum tolerated dose of an investigational drug is determined

In phase III trials is where the maximum tolerated dose of an investigational drug is determined

CFR21 Part 50 on “The Protection of Human Subjects” was written directly in response to:

 

Death of children from the use of antifreeze ingredient used as sweetener in antibiotic sulfanilamide elixir

 

New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama

 

World Medical Association’s Declaration of Helsinki

 

The Nazi war criminal trials on unethical “science” experiments in Nuremberg, Germany

 

Deformities that occurred as a result of the morning sickness drug, Thalidomide.

New York Times expose on unethical syphilis experiments in Tuskegee Clinic in Alabama

What is true about ICH?

 

GCP guidelines are covered under ICH Q6

 

GCP guidelines are covered under ICH E6

 

ICH is an organization tasked to prosecute violations of GLP regulations by drug manufacturers

 

Organized to expose drug manufacturing practices that are non-compliant with regulations

 

ICH favors delaying the introduction of new drug products into the global marketplace

GCP guidelines are covered under ICH E6

What applies to informed consent?

 

Participants are informed that their health may or may not improve as a result of participating in the trial

 

Participants are prevented from being negatively influenced by family members

 

The informed consent should always be communicated to participants in English

 

A process by which a subject is coerced to participate in a particular trial after being informed of all aspects of the trial

 

An informed consent is required even when participants are in life threatening situations

Participants are informed that their health may or may not improve as a result of participating in the trial

What is not one of the principles of GCP according to ICH guidelines?

 

Records must be accurate, maintained, and kept confidential

 

Clinical study design must be scientifically and statistically sound

 

Clinical trial supplies must have been manufactured according to cGMP regulations

 

Clinical trial supplies must meet Good Manufacturing Practices standard

 

Possible benefits of trial participation must greatly outweigh the risks to a patient’s health

 

Investigators should routinely deviate from the FDA-approved clinical trial protocol

Investigators should routinely deviate from the FDA-approved clinical trial protocol

What is not meant to be answered by conducting clinical trials?

 

What are the harmful effects of the investigational drug on humans?

 

What does the investigational drug do to normal bodily functions?

 

Does the investigational drug treat, cure, or provide relief for a particular condition?

 

Does the investigational drug improve the skill and dexterity of investigators?

 

What happens to the investigational drug upon administration to humans?

Does the investigational drug improve the skill and dexterity of investigators?