Good Pharmacoepidemiology Practice

Kelompok :
O Niko Rupoko O Ratih Kumala P O Riska Wulandari O Titi Murti O Annisa Trisfalia O Aida Aini O Ghina Rahimah A

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260110100159 O Seung Hyun Kim O Karen Low

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Goal Good Pharmacoepidemiology Practice

The GPP have the following specific goals : 1. To assist researchers in adhering to good pharmacoepidemiologic research principles, including the use of pharmacoepidemiologic studies for risk management activities. 2. To promote sound pharmacoepidemiologic research by encouraging rigorous data collection, analysis, and reporting.

3. To provide a framework for conducting

and evaluating pharmacoepidemiologic studies. 4. To facilitate the appropriate utilization of technical resources by promoting careful study design and planning of study conduct.

Benefits following the guidline for pharmacoepidermiology studies

O assist investigators with issues
O Differentiate from industry and regulatory

perspectives. O Provided guidance O add clarification O Address the study

O intended to assist investigators with issues

O O

pertaining to the planning, conduct, and evaluation of pharmacoepidemiologic research. include risk management and pharmacoeconomic activities, and to address more clearly the role of epidemiologic studies from industry and regulatory perspectives. Provided guidance on regulatory reporting requirements use and communication of statistical measures and to add clarification to specific items throughout the document Address the study of pharmacoepidermics and the benefits.

The Good Pharmacoepidemiology Practice address the following areas : O Protocol development. O Responsibilities, personnel, facilities, resource commitment, and contractors. O Study conduct. O Communication. O Adverse event reporting. O Archiving.

Protocol Development
OA protocol should be drafted as one of the

first steps in any research project, and the protocol should be amended and updated as needed throughout the course of the study.

The protocol should include the following elements:

Title Name, title, degree of all responsible parties

Name and address of sponsors

Abstract of Protocol The proposed study tasks and timeline A statement of research objectives A critical review of the literature to evaluate pertinent information

A description of the research method

A. B. C. D.

Overall research design and strategy Population or sample to be studied Strategies and data resources Clear operational definitions of criteria and comparison group

E.

Projected study size, statistical precision, and the basis for their determination
Methods Procedures

F. G. H. I. J.

Data analysis
Description of quality assurance and quality control Limitations of the study design and analytic methods

Description of plans (for protecting human subjects) Description of plans (for disseminating and communicating study result) Resources required to conduct the study References Dated amendments to the protocol

RESPONSIBILITIES, PERSONNEL, FACILITIES, RESOURCE COMMITMENT, AND CONTRACTORS

O Relationship O Roles O Responsibilities

Personal must be TEE-HEE

Organization : 1. Keep summary of my training & experience 2. Job titles given 3. Updated always

O Training O Education O Experience

Adequate Facilities
O Office space
O relevant equipment O office/professional supplies O storage facilities : technical records in a

secure and confidential environment in compliance with local regulations

Resource commitment
O Beginning : ensure its timely and proper

completion.

Contractors
O Purposes: documenting the contractors

conformance with the GPP.

O study sponsor have the right to inspect the

contractors facilities(equipment, technical record, and records relating to the work conducted under the sponsors contract)

O The nature of the audit, including procedures

that ensure patient confidentiality, should be agreed upon at the outset of any contract.

Study Conduct

Protection of Human Subjects

Data Collection, Management, and Verification

Analysis Study Reports

Protection of Human Subjects

To have any research that is involving human subjects it requires an approval from IRB (Instituitional Review Board) and IEC (Independent Ethics Committee). Investigators shall ensure that personal identifiers will be removed from any study files that are accessible to non-study personnel in accordance with applicable laws and regulations. For blood and serum sample collections stored after completion of clinical studies are a valuable resource.

Data Collection Management and Verification

O All data collected for the study should be recorded

accurately, promptly, and legibly, because it has the responsible for the integrity of the data, computerized and hard copy, identification, education, traning, and even the experience to perform the assigned tasks. Data should always be secured, such as encrypting the documents, increase the level of authenticity, and access limitation. Adequate backup of the data should also be maintained throughout the course of the study.

Analysis
It is divided into three parts:

Presenting clearly defined statistical analysis plan with

statistical procedures.

All data management and statistical analysis programs and packages used in the analyses should be documented and archived. The analysis should be directed toward the unbiased estimation of the epidemiologic parameters of interest (e.g., risk or rate differences, risk or rate ratios). The precision of effect estimates should be quantified separately using confidence intervals.

Study Reports
O Completed studies shall be summarized in a final report

that accurately and completely presents the study objectives, methods, results, limitations of the study, and interpretation of the findings.
O Final report shall include at minimum:

Title Abstract Purpose/Objective of the research

Name and titles and etc. of all co-investigators Name and address of sponsors Dates on which the study was initiatied and completed Introduction with background, purpose, and specific aims Description of research methods Description of circumstances that may have affected the quality Analysis of the data Conclusion

Discussion of the result

References

Communication
Predetermine following procedures: O Intent O Conduct O Results O Interpretation of an pharmacoepidemiologic study will occur
Documented in company SOP, study protocol, or contractual agreement.

Communication
O Result section -> epidemiologic

quantitative measurement, directly or graphically. O Include both relative and absolute risk estimates. O Acknowledge the sources of research funding

Adverse Event Surveillance

O The ndings of epidemiologic studies of

health risks associated with healthcare products must be reported by pharmaceutical sponsors to regulatory agencies O Relevant regulatory guidance documents should be consulted.

Adverse Event Surveillance

O Adverse drug reactions are often

confused with medical errors in a surveillance system. O It is equally important to monitor prescribers in a surveillance system to determine the causality of the medication problem.

Adverse Drug Reaction Surveillance

O Rather than using adverse drug reaction

reports to create medication guidelines and restrictions, pharmacists may instead choose to study a particular drug reaction further using pharmacoepidemiological methods.

O Benefits of using more formal

pharmacoepidemiological methods: 1. the ability to quantify the rate at which the adverse drug reaction is occurring 2. the ability to identify various risk factors associated with it.

The results of these observational studies can then be used to create guidelines and restrictions on the use of drugs within institutions.

Archiving
O Secure archives must be maintained for the

orderly storage and expedient retrieval of all studyrelated material. O An index shall be prepared to identify O The archive should be maintained for at least 5 years after nal report or rst publication of study

Study Archive Should Refer To:

A. Study protocol and all approved

modications. B. A nal report of the study. C. All source data and, where feasible, any biologic specimens. The archival material should be sufciently detailed to permit re-editing and re-analysis.

D.Documentation adequate to identify and locate all computer programs and statistical procedures E.Copies of electronic versions of analytic data sets and programs, computer printouts. Any manually developed calculations shall be documented on a work sheet and similarly retained.

F. Correspondence pertaining to the study. Communication of study results to the sponsor, regulators, and scientic community should be documented. Include, for example, questionnaires, name, make and model numbers of relevant measurement instruments, calibration information, and procedures. G. Documentation relating to the collection and processing of study data, including laboratory/ research notebooks, training and reference documents for abstracts, interviews, and coders.

REFERENCES
O Chemical Manufacturers Associations

Epidemiology Task Group. Guidelines for good epidemiology practices for occupational environmental epidemiologic research. J Occup Med 1991; 33: 12211229. O Austin MA, Ordovas JM, Eckfeldt JH, et al. Guidelines of the National Heart, Lung, and Blood Institute Working Group on Blood Drawing, Processing, and Storage for Genetic Studies. Am J Epidemiol 1996; 144: 437441.