Evidence Based Medicine

Question 1

Evidence Based Medicine

Answer 1

• Integration of best research with clinical expertise and patient values
• How many people improved compared to the control group which can create scientific evidence and affect patient care

Question 2

5As

Answer 2

1. Ask a clinical question
2. Acquire the best evidence
3. Appraise the evidence
4. Apply the evidence
5. Assess the impact
   * *Start from the top**

Question 3

EBM Pros

Answer 3

• Rigorous standards
• Placebo effect is accounted for in RCT
• Best guidelines take into account COI, statistical, and clinical significance of the findings

Question 4

EMB Cons

Answer 4

• “My patient is different”
• “Cookbook medicine”
• RCT = rigid criteria and compliance higher than in real life
• Many scenarios/patients for which there are no EBM studies

Question 5

Drug Approval Process

Answer 5

1. Preclinical Submit IND after this
2. Phase 1 - Safety
3. Phase 2 - Safety/Dosing
4. Phase 3 - Efficacy Submit NDA after this
5. Post-Marketing - Effectiveness

Question 6

Pharmacoepidemiology

Answer 6

• Study of the use/effect of drugs in large numbers of people
• Focus - borrowed from clinical pharmacology
• Method - borrowed from epidemiology
• Most applied in post-marketing surveillance

Question 7

Evaluation Need in Postmarketing

Answer 7

• Withdrawal - 3-4% of medicines in past 20 years
• Limitations with Pharm IV trials (serious, uncommon ADR) like limited N, short duration, narrow criteria
• New ADRs found in post-marketing are common

Question 8

Pharmacoepidemiology Studies Reasons

Answer 8

1. Regulatory
2. Marketing
3. Legal
4. Clinical

Question 9

Regulatory Reasons

Answer 9

• Required by FDA in post-marketing
• Obtain early approval for marketing
• In response to AE reports to FDA
• Assist application for approval for international marketing

Question 10

Marketing Reasons

Answer 10

• Assist market penetration
• Increase name recognition
• Re-position drug (Different populations, indications, etc)
• Protect drug for AE accusations

Question 11

Legal Reasons

Answer 11

• Plaintiffs must prove causations, damages, negligence

- Post marketing studies show attempt to detect toxic effects

Question 12

Clinical Reasons

Answer 12

• Hypothesis testing (detect beneficial/harmful drug effects)
• Hypothesis generation