bhumika 5 post marketing studies

7/30/2019 Bhumika 5 Post Marketing Studies

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Limitations of Premarketing Clinical

Trials

Size of the patient population studies

Narrow population often not providing for special groups

Elderly, children, women

Narrow indications studied

Exclusion of certain disease states

Short duration

Not reflective of a drugs potential chronic use


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Phase IV or Post marketingSurveillance No fixed duration / patient population

Starts immediately after marketing

Report all ADRs

Helps to detect

rare ADRs

Drug interactions

Also new uses for drugs [Sometimes called Phase V]


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An Ideal Registry Design

Actively collects information

STUDY POPULATION exposed and unexposed patients with the same baseline

risk, identified prospectively

EXPOSURE MEASUREMENT dose, duration and timing of all relevantmedications

OUTCOME MEASUREMENT complete ascertainment of outcome in both groups

COVARIATES complete information on all potential confounders and effect

modifiers

FOLLOW-UP complete follow-up time period sufficient to observe outcomes

POWER ability to detect or rule out an increased risk of X over the exposed

or observed in the unexposed group


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Definition of a Post Marketing Commitment

As a requirement for the approval or continued marketing of medicines, US

Food and Drug Administration (FDA) or the European Medicines Agency (EMA)may require additional information on a product to be generated, in the form

of post marketing commitments (PMCs). These commitments are agreed to bya company with the health authority and are used to gather additional

information about a medicine's safety, efficacy, or optimal use. Postmarketing commitments can be required either before or after the health

authority has granted approval to a company to market a medicine. 1

In the EU, PMCs are also known as Post Approval Commitments (PACs) and maytake the form of follow-up measures (FUMs) or Specific Obligations (SOs).


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Post Marketing Studies

Clinical Trials studies to answer specific questions about new treatments ornew ways of using known treatments.

Clinical trials (also called medical research and research studies) are used tohelp determine the benefit/risk profile of new medicines and treatments.

Carefully conducted clinical trials are the fastest and safest way to find what

medicines and treatments work, and to understand any potential limitations

to their use.


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Types of clinical trials include:

Randomized clinical trials (RCTs)

Drug interaction studies

Efficacy studies

Large simple trials (LSTs)

Pharmacokinetic and pharmacodynamic studies

Safety studies

Completion of ongoing study


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Pediatric studies

Efficacy studies

Pharmacokinetic and pharmacodynamic studies

PREA studies In the United States the Pediatric Research Equity Act of 2003

requires new drug applications (and supplemental applications) to contain apediatric assessment.6 At the time of regulatory approval, these pediatric

studies may be required as a post marketing commitment.
http://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossary


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Safety studies Safety studies may be conducted in several forms, and may be carried out toevaluate the safety of a medicinal product.

Special population studies such as pregnant women, children, geriatric (elderly) patients,patients with specific disease characteristics, such as liver (hepatic) impairment or kidney(renal) impairment, or patients with specific reactions to treatment, such as change in QTinterval (heart rate measurement).

New dosage form/strength studies Studies testing different dosage forms/strengths ordelivery systems.

Other types of studies can include:

Pre-clinical studies Testing of medicines in the test tube (in vitro) or in animals. Thistypically occurs before trials in humans may be carried out, but may be required at anytime.2 These studies may examine carcinogenicity, microbiology or toxicology.

Epidemiological studies Non-interventional studies of incidence, distribution and control ofa disease in a given population.2 Epidemiological studies can also be designed to evaluatedrug safety.


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Safety registry Generally non-interventional studies, registries arerepositories where data, records or laboratory samples are kept and may be

made available for research or comparative study.

For example, physicians may maintain lists of patients who share a characteristic,

such as a medical condition or medication regimen.

Safety registries capture and document ongoing safety and outcomes data in

patient populations under real-world treatment conditions.

Other types of registries include disease registries, drug registries and pregnancy

registries.

Other types of activities to address a specific commitment may include for

example, a labelling comprehension study, a commitment to convene anexpert panel, or an education program.
http://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossaryhttp://www.pfizer.com/research/pmc/glossary


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Development Process for Post

Marketing Studies

Protocol development

Investigator start-up

Subject recruitment

Conducting a study

Reporting PMs progress


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US Post Marketing Commitment Status Definitions

Post marketing commitment progress is reported on this website using the following status descriptions [(consistent with the definitionsused in the US by the FDA)]:1

Pending The commitment has not been initiated (i.e., no subjects have been enrolled or animals dosed), but does not meet the criterionfor delayed (i.e., the original projected date for initiation of animal dosing has not passed).

On-going The commitment is proceeding according to, or is ahead of, the original schedule. A study will be considered to be on-going untila final study report is submitted to the health authority, as long as the activities are proceeding according to the original study schedule. Ifpatient accrual or animal dosing has started but is not complete, and the projected date for completion of that milestone has passed, thestudy should be categorized as delayed.

Delayed The progression of the commitment is behind the original study schedule. Delays can occur in any phase of a s tudy, includingpatient enrollment, analysis of study results or submission of the final study report to the FDA. While the original study schedule not arevised schedule serves as the basis for defining a study as delayed, each phase of the study will be considered in its own right. If thecompany has one delayed phase, but gets back on schedule during the next phase, the delayed status will no longer apply.

Terminated The company ended the study before completion, and has not yet submitted a final study report to the FDA.

Submitted The company has concluded or terminated the commitment and has submitted a final study report to the FDA, but FDA has notyet notified the applicant in writing that the study commitment has been fulfilled or that the commitment has been released.

Fulfilled The company has submitted the final study report for the commitment, and upon review of the final study report, FDA is satisfiedthat the applicant has met the terms of the commitment.

Released FDA has informed the company that it has been released from its obligation to conduct the post marketing commitment becausethe study is either no longer feasible or would no longer provide useful information.


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EU Post Marketing Commitment Status Definitions

Pending The commitment has not been initiated.

On-going The commitment is proceeding according to, or is ahead of, the originalschedule.

Delayed The progression of the commitment is behind the original schedule.

Terminated The commitment has been terminated.

Submitted The company has submitted the required information to the Agency

but has not yet been notified that the commitment has been fulfilled.

Fulfilled The company has submitted the required information to the Agency andupon review of the Agency is satisfied that the applicant has met the terms of thecommitment.

Released The Agency has informed the company that it has been released fromits obligation to conduct the post approval commitment.

bhumika 5 post marketing studies

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