Quiz 9 BTEC 3317

What is not true of the study protocol?

 

The study protocol includes a description of the personnel and their qualifications, and trial subjects who will be involved in the clinical study

 

The study protocol is designed to protect the health, safety and psychological well-being of the trial participants.

 

The study protocol cannot be changed at any time by trial sponsors

 

The study protocol is designed to answer specific research questions about the behavior, safety and efficacy of an investigational drug

 

The study protocol allows researchers at multiple locations to perform the study in exactly the same way so that their data can be combined as though the study was done in a single site.

The study protocol cannot be changed at any time by trial sponsors

What is not true of the trial sponsor?

 

The trial sponsor takes responsibility for initiating, managing, and financing a clinical investigation

 

The trial sponsor files the marketing application with the FDA after successful clinical trial results

 

The trial sponsor is responsible for ensuring compliance with regulatory requirements, including adherence to good clinical practices

 

The trial sponsors are appointed by the study monitors

 

The trial sponsor can be a federal agency like the Center for Disease Control (CDC) or the National Institutes of Health (NIH)

The trial sponsors are appointed by the study monitors

What is not true of the Institutional Review Board?

 

The IRB is designated by the trial sponsor to approve, monitor, and review biomedical and behavioral research protocols involving humans.

 

The IRB assures that the clinical trial protocol complies with regulations

 

The IRB is an independent group that ensures the protection of the rights, safety, and well-being of human subjects

 

The IRB assesses whether the benefit of participating in the trial outweighs the possible risks to the health of trial subjects

 

Any change in the study protocol must have approval from IRB, except in life threatening situations

The IRB is designated by the trial sponsor to approve, monitor, and review biomedical and behavioral research protocols involving humans.

_______________ is a document given by the investigator to the sponsor to provide the sponsor with information about the qualifications of the PI, and at the same time remind the PI of his or her regulatory responsibilities.

 

FDA form 1570

 

Investigator’s Brochure

 

Statement of Investigator

 

FDA Form 483

 

Informed Consent

Statement of Investigator

Under the FDA's Bioresearch Monitoring Program, if a clinical trial investigator receives an official action indicated after an inspection and chooses to ignore it, he will be issued a warning letter. What is not true of an OAI?

 

With an OAI, FDA requires a response from the investigator within 15 days

 

An OAI can simply lead to throwing out of the investigator’s clinical data

 

An OAI is the least common outcome of an FDA’s inspection of a clinical trial site

 

An OAI may result to disqualification of an investigator from participation in any future clinical research

 

An OAI is issued after inspection when minor violations are observed

An OAI is issued after inspection when minor violations are observed

Jesse Gelsinger was a clinical trial participant in one of the first clinical trials on an investigational gene therapy approached approach that tested adenovirus as a vector to introduce a functional gene to replace a defective gene. He died as a result of a massive immune response to the AAV. What is not a GCP violation that the investigators involved were found to have committed?

 

There were conflict of interests, i.e., scientists and the hospital were getting research funding from the company sponsoring the trial

 

Jesse had a health condition that should have excluded him from participating in the trial

 

Trial participants were not completely informed of deaths of monkeys in pre-clinical studies

 

Investigators ignored previous reports of serious adverse reaction in two other patients

 

The principal investigator assigned to the trial employed unqualified and improperly trained staff

The principal investigator assigned to the trial employed unqualified and improperly trained staff

FDA will not impose a clinical hold on a trial if:

 

The FDA has questions about the quality or sterility of the investigational drug based on information in the chemistry, manufacturing and controls portion of the IND submission

 

The FDA finds issues with pre-clinical animal safety data in the IND submission

 

While the trial is being conducted, unreasonable adverse health effects on patients started to show up

 

The trial sponsor has not paid the required PDUFA fee

 

The FDA finds that the study protocol or design proposed in the IND submission does not provide sufficient assurance that risks to the of health study participant would be minimized

The trial sponsor has not paid the required PDUFA fee

Of about 5000 drugs that companies investigate as a drug candidate, only 1 will successfully make it to market. What is the top cause of drug failure?

 

The investigational drug just was not effective in humans

 

The test drug has unacceptable adverse effects in human trials

 

The new drug will not be able to compete successfully with the earlier marketed drug

 

Unfavorable pharmacokinetics

 

The investigational drug exhibited unacceptable toxicity to test animals

Unfavorable pharmacokinetics

The Common Technical Document:

 

Is provided by investigators to trial sponsors in US, EU or Japan, to provide data and information about the qualifications of the investigators

 

Is provided to clinical trial investigators in US, EU or Japan, to provide data and information about the investigational drug to be tested

 

Contains data and information submitted as part of marketing applications for a pharmaceutical for human use for US, EU or Japan.

 

contains data and information submitted as part of a requirement prior to field testing of crops engineered to produce novel proteins

 

contains data and information provided to clinical investigators in US, EU or Japan to guide the conduct of a clinical trial

Contains data and information submitted as part of marketing applications for a pharmaceutical for human use for US, EU or Japan.

In which type of marketing application would it be typical for the FDA to require efficacy data for a marketed drug being submitted for use in a new indication, and not require additional safety data?

 

Over-the-counter drug application

 

Supplemental New Drug Application

 

Orphan drug application

 

Abbreviated new drug application

 

Biologics license application

Supplemental New Drug Application

What type of information is not contained in a New Drug Application (NDA) which is submitted to the FDA?

 

The NDA should provide evidence that methods used in manufacturing assured the drug's quality

 

The NDA should provide results of drug safety from pre-clinical and clinical studies

 

The NDA should provide evidence that there are no alternatives to the use of primates in safety tests

 

The NDA should prove that the drug's proposed labeling (package insert) is accurate and informative

 

The NDA should provide evidence that the drug is safe and effective in its proposed use(s)

The NDA should provide evidence that there are no alternatives to the use of primates in safety tests

New Drug Applications (NDA) have chemistry, manufacturing and controls (CMC) section that tells the whole story about the candidate drug. Which type of information is included in the CMC?

 

The ingredients or components of the drug product

 

Evidence that the clinical trial protocol was designed to minimize risks to trial participants

 

Evidence that there is a substantial pool of patients that is in need of the new drug

 

Evidence that there are no alternatives to the use of primates in safety tests

 

The changes in gross morphology of test animals

The ingredients or components of the drug product

When is a complete response letter (CRL) issued by the FDA in response to a drug marketing application?

 

A CRL is issued if the drug failed to demonstrate effectiveness in human clinical trials

 

A CRL is issued if the clinical trial plan in a proposed IND is unacceptable

 

A CRL is issued if there were no safety issues observed during the clinical trials

 

A CRL is issued if the required prescription drug user fee has not been paid

 

A CRL is issued if the drug is approved for marketing

A CRL is issued if the drug failed to demonstrate effectiveness in human clinical trials

What is not correct about patents and marketing exclusivity?

 

Patents are granted by the USPTO and expire 20 years from date of filing

 

Marketing exclusivity is granted by the USPTO upon drug approval to protect the drug from generic competition

 

Marketing exclusivity can extend protection from generic competition beyond the patent life.

 

Orphan drug designation adds 7 years of market exclusivity from generic competition

 

Marketing exclusivity can be concurrent with a patent

Marketing exclusivity is granted by the USPTO upon drug approval to protect the drug from generic competition

A __________ is granted by FDA to market an unapproved drug when there is an infectious disease that poses a serious threat to public health and when there is no currently formally approved drug for treatment of the disease

 

Emergency Use Amendment

 

Emergency Use Allowance

 

Emergency Use Approval

 

Emergency Use Authorization

 

Emergency Use Administration

Emergency Use Authorization