Overview Of New Drug Development

Development of most new drugs from discovery to marketing approval usually takes:

Answers: 9 years or more

The first randomized, controlled study of an experimental drug versus aspirin for postoperative pain control will enroll 55 subjects in each arm. Which of the following best describes the clinical phase of this study?

Answers: Phase II

Adults with more than a 12-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was 1200 subjects. Which of the following best describes the clinical phase of this study?

Answers: Phase III

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

Answers: Preclinical

Pharmacokinetics and pharmacodynamics of a new formulation of an investigational drug most likely refers to which clinical phase of a study in humans?

Answers: Phase I

For a phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?

Answers: Preclinical data

Which of the following are the three principles included in the Belmont Report?

Answers: Respect for Persons, Beneficence, Justice.

Which of the following is an example of how the Principle of Beneficence can be applied to a study employing human subjects?

Answers: Determining that the study has maximized benefits and minimized risks.

Which of the following best describes the principle of informed consent as described in the Belmont Report?

Answers:Information, comprehension, voluntariness.

Development of most new drugs, from discovery to marketing approval, usually takes:

Answers: 9 years or more

Adults with more than a twelve (12)-month history of migraines were assigned randomly in a double-blinded study to receive treatment with experimental drug X (10 or 20 mg/day) or placebo. The primary efficacy measure was the reduction in severity of the migraine attacks. Enrollment was twelve-hundred (1200) subjects. Which of the following best describes the clinical phase of this study?

Answers: Phase III

Long-term toxicology of an experimental drug in animals most likely refers to which part of drug development?

Answers: Preclinical

For a Phase I new drug study in humans, what is the primary source of the data included in the initial Investigator’s Brochure?

Answers:Preclinical data

The ICH GCP guidelines:

Answers: Set standards for the design, conduct, monitoring and reporting of clinical research.

In the United States, following the ICH E6 guideline is:

Answers: Voluntary for FDA-regulated drug studies.

ICH E6 has broader requirements than FDA or HHS concerning the confidentiality of medical records and access by third parties. If investigators are complying with ICH E6 guidelines, they must:

Answers: Clearly disclose to subjects in the informed consent form that the monitor, auditor, IRB/IEC, and the regulatory authorities may have access to the subject’s medical records

The new ICH E6(R2) integrated addendum requires sponsors to implement systems to manage quality throughout all stages of the trial process. The system should use a risk-based approach including which of the following?

Answers:Identification of study risks to determine which may safely be omitted from continual monitoring.

When the sponsor-investigator holds the IND for an investigational drug he or she is responsible for annual reporting of which one of the following to FDA?

Answers:IND report

Which of the following is an acceptable criterion for determining that a study of an approved drug does not require an IND?

Answers: The study is not intended to be reported to FDA to support a new indication or support a labelling change.

The investigational product dispensing or administration information for the sponsor is recorded on the:

Answers:  Case report form

A 46-year-old man is currently enrolled in a Phase III study of a drug for severe diabetic neuropathy. While the study is ongoing, a new drug becomes commercially available that may have an equal or greater benefit to the subject. The investigator should do which of the following?

Answers: Discuss the pros and cons of both the investigational drug and the commercially available drug and then allow the subject to decide whether to withdraw from the research to take the new drug.

Subject 311 has had elevated white blood cell (WBC) counts for the past two (2) study visits, with no clinical signs or symptoms. “Increased WBC count” is not listed in the Investigator’s Brochure (IB) as an adverse event. The investigator should:

Answers: Report the elevated WBC to the sponsor as an unexpected adverse event

When should the sponsor-monitor conduct the most detailed review of the study protocol with the site’s study staff?

Answers:  Site initiation visit

Which of the following best describes when the majority of case report form (CRF) data are verified against source record information?

Answers: Periodic site visits