Lecture 5: Regulation of Pharmacoepidemiology Research Flashcards Preview

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Flashcards in Lecture 5: Regulation of Pharmacoepidemiology Research Deck (11):
1

What was the significance of the FDA amendment act (FDAAA) of 2007?

1) Increased authority to require postmarketing studies and/or clinical trials
2) authority to require changes to drug labeling
3) Mandate to develop guidance on best practices for epi studies
4) Mandate to develop a new post-market risk identification and analysis system

2

Types of observational epidemiological studies that FDA may require

1) Assess a serious risk associated with a drug exposure or to quantify risk or evaluate factors that affect the risk of serious toxicity (eg, drug dose, timing of exposure, or patient characteristics)
2) examine natural history of a disease or to estimate background rates for adverse events in a population not treated wth the drug

3

FDA postmarking study requirements

1) Develop study protocol (analytic study or descriptive study)
2) Must submit periodic reports on status, including any challenges to meeting study timelines
3) Non-compliance may result in financial penalties and/or drug distribution limitations

4

Define Comparative effectiveness research

-Research that provides evidence on the effectiveness, benefits and harms of different treatment options.
-Evidence is generated from studies that compare drugs, medical devices, tests, surgeries or ways to deliver health care
-Designed to inform health care decisions such as reimbursement.

5

US Pubic disclosure requirements

There is currently no US legal requirement to disclose non interventional studies

6

EU definition of non-interventional study

A study where: the medicinal products are prescribed in the usual manner in accordance with the terms of the marketing authorization
Note that the assignment of a patient to a particular therapeutic strategy is not decided in advance by a trial protocol, but falls within the current practice

7

EU definition of low interventional clinical trial

A study where: the investigational medicinal product is authorized. Assignment to a particular therapeutic strategy is decided in advance by a trial protocol and taken together with the decision to include the patient (ex. LST)

8

Post Authorization safety studies (PASS)

Imposed as a condition of or following marketing authorization
Includes non-interventional (observational) and interventional studies (involves randomization)

9

Post Authorization efficacy studies (PAES)

-Complements the data available at the time of authorization with additional information concerning the efficacy of a medicinal product.
-addresses concerns that could not be resolved prior to market authorization
-European commission empowered to require PAES

10

ENCePP Guidance

European Network of centers for pharmacoepi and pharmacovigilance: a collaborated scientific network coordinated by the EMA

11

ISPE guidance

International Society for Pharmacoepidemiology provides guidelines for pharmacoepi practices