This document discusses the importance of evaluating clinical literature and provides guidance on how to systematically approach literature evaluation. It describes how to identify the level and type of reference (tertiary, secondary, primary), and provides tips for evaluating different aspects of clinical studies, such as the objective, subjects, treatment administration, setting, methods, controls, and data analysis. The document also discusses how the FDA communicates important drug safety information to healthcare professionals and the public.

1. Clinical Literature Evaluation
Dr. Ahlam Sundus

2. Importance of clinical literature
Information and knowledge needs of health care
professionals and patients,
Characterize, evaluate, and refine clinical processes,
Develop, implement, and refine clinical decision support
systems, and
Lead or participate in the procurement, customization,
development, implementation, management, evaluation,
and continuous improvement of clinical information
systems.

3. Literature evaluation is a skill
Developed with repeated use
Learn to identify limitations
Determine internal and external validity of a trial
Internal Validity – the degree to which the results are attributable to the independent variable and not some other rival explanation (confounders)
External Validity – the extent to which the results of a study can be generalized

4. Why is it necessary to evaluate literature
Pharmacist questioned during round on newly
published research
Should have skills to decide whether to use the skills
of the trials to the patients or not?
Critical evaluation of literature to include a drug into
formulary
To decide which info to incorporate into clinical
practice

5. Systematic Approach
 Developed in 1975
 A strategy to teach pharmacy students drug information skills
 7 steps (5 steps originally)
Step 1 secure demographics of the requestor
Step 2 obtain background info that led to the question
Step 3 determine and categorize the ultimate question
Step 4 develop a strategy and conduct research
Step 5 perform evaluation, analysis and synthesis
Step 6 formulate and provide response
Step 7 conduct follow-up and documentation

6. Searching drug information literature
Best way to follow organized, stepwise
approach i.e.
Start form tertiary resources, followed by
secondary and primary resources

7. Tertiary References
 Quick access
 Background knowledge of the topic
 E.g. textbooks, compendia (hospital formulary, physician’s
desk, reference etc.), and computer databases
(MICROMEDEX)
 Review articles are also categorized into tertiary literature
 Narrative review, systematic review and meta-analysis?
 Drawback:
 Out-of-date, info may not be complete

8. SECONDARY REFERENCES
Identify primary resources
Typically used when tertiary source is out-of-date e.g.
new drugs, new use of older drug
E.g. indexing and abstracting services
Provide citation of the article and abstract written by the
author
MEDLINE. PubMed, International pharmaceutical
abstract etc.

9. PRIMARY REFERENCE
 More current, in-depth information required
 Includes studies, original reports of data
 Proceedings of Meetings, conferences and symposia;
 Records of organizations, government agencies (e.g. annual report, treaty, constitution,
government document);
 Speeches;
 Survey Research (e.g., market surveys, public opinion polls);
 Video recordings (e.g. television programs);
 Web site
 Drawback:
 May be biased
 Requires critical evaluation
 Important info may be missed if consulted solely
 Methodological flaws

10. Evaluating a Clinical Study
 Evaluate the objective of study
 Researcher intended to examine
 Goal stated clearly
 Single objective/ multiple effects being tested
 Evaluate the subjects of the study
 Healthy/affected
 Volunteers
 Criteria for selection
 Evaluate administration of treatment
 Evaluate the setting of the study
 Length of study
 Physical setting
 Who collected data

11.  Evaluate method/design of study
Methods clearly described
Retrospective/prospective
 Treatment allocation
Parallel design
Cross over design
 Evaluate controls
Blinding
Random allocation
Placebo
Comparison
 Evaluate method analysis

12. Drug Safety Information Communication – FDA
Timely communication of important drug safety
information provides health care professionals, patients,
consumers, and other interested persons with access to
the most current information concerning the potential
risks and benefits of a marketed drug, helping them to
make more informed treatment choices.

13. background
 All drugs have risks, and health care professionals must
balance the risks and benefits of a drug therapy when making
decisions about whether to use the drug
 The general risks and benefits of a drug therapy are
described in the product’s prescribing information.
 FDA provides information on drug risks and benefits to health
care professionals and patients when that information has
generated a specific concern and has prompted a regulatory
action, such as a revision to the drug’s prescribing
information.

14. Examples of important drug safety issues
include, but are not limited to:
 Serious adverse drug reactions identified after drug approval
 Medication errors, which include, but are not limited to,
confusion between drug names and confusion regarding drug
labeling. These may lead to improper use of the drug, to
prescribing or administering an improper dose, or to a
patient’s taking another medication with which the drug
interacts.

15. FDA may decide to issue a Public Health Alert
or a Press Release about a medical product or
hold a media briefing to communicate important
risk information.

16. When Does FDA Communicate Emerging Drug
Safety Information to the Public?
 FDA considers many factors in deciding whether emerging drug safety
information should be made available to the public.
 These factors may include, but are not limited to, the following:
 Seriousness of the event (e.g., severity and reversibility) relative to the
benefits of treatment
 Magnitude of the risk (e.g., likelihood of occurrence)
 Strength of the evidence of a causal relationship between the use of a
drug and the adverse event
 Extent of patient exposure (e.g., how broadly the drug is used)
 Disproportionate impact on particular populations (e.g., children or the
elderly)

17.  Potential for preventing or mitigating the risk in the patient
population (e.g., by monitoring patient selection or avoiding a
concomitant treatment)
 Availability of alternative therapies

18. How Does FDA Communicate Important Drug
Safety Information to the Public?
 FDA has created effective and ongoing relationships with a
wide array of trade and professional associations, patient
advocacy and consumer groups, safety organizations, media,
and other entities.
 tools and methods to communicate drug safety information to
the public
 FDA-approved prescribing information (i.e., drug labeling)
 Drug Safety Communication (DSC)- a post-market
communication tool

19. What is FDA-approved labeling ?
 FDA-approved prescribing information for health care
professionals — and patient package inserts and Medication
Guides for patients — is the primary source of established
information about a drug’s safety and efficacy; it summarizes
the essential scientific information needed for the safe and
effective use of the drug.

20. Features of FDA-approved labeling
 Patient-focused information (patient labeling) could help prevent
serious adverse effects
 A drug product has serious risk(s) (relative to benefits) of which
patients should be made aware because information concerning
the risk(s) could affect a patient’s decision to use, or to continue to
use, the product
 A drug product is important to health, and patient adherence to
directions for use is crucial to the drug’s effectiveness.

21. What is Drug Safety Communication?
 A Drug Safety Communication (DSC) is a specific tool used by FDA to
communicate to the public important information about safety issues, including
emerging safety information, about marketed drugs
 DSCs generally communicate the following information:
 A summary of the safety issue and the nature of the risk being communicated
 The established benefit or benefits of the drug being discussed
 Recommended actions for health care professionals and patients, when
appropriate
 A summary of the data reviewed or being reviewed by FDA