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Literature DB >> 338116

The case for recording events in clinical trials.

Abstract

The value of clinical trials in detecting unwanted effects of new medicines would be enhanced if doctors recorded all adverse events experienced by patients and not just those regarded as adverse reactions to drugs. All events should be reported to the centre co-ordinating the trial and analysed in treated patients and controls. This method might have revealed the ocular toxicity of practolol before the drug was marketed in 1970.

Entities: Chemical Disease Species

Mesh：

Year: 1977 PMID： 338116 PMCID： PMC1632767 DOI： 10.1136/bmj.2.6101.1523

Source DB: PubMed Journal: Br Med J ISSN： 0007-1447

7 in total

1. THE DESIGN AND LOGIC OF A MONITOR OF DRUG USE.

Authors: D J FINNEY
Journal: J Chronic Dis Date: 1965-01

2. Adverse drug reactions-a matter of opinion.

Authors: F E Karch; C L Smith; B Kerzner; J M Mazzullo; M Weintraub; L Lasagna
Journal: Clin Pharmacol Ther Date: 1976-05 Impact factor: 6.875

3. Measurement of side effects of drugs.

Authors: E C Huskisson; J A Wojtulewski
Journal: Br Med J Date: 1974-06-29

4. Comprehensive drug surveillance.

Authors: H Jick; O S Miettinen; S Shapiro; G P Lewis; V Siskind; D Slone
Journal: JAMA Date: 1970-08-31 Impact factor: 56.272

5. Side effects of hypotensive agents evaluated by a self-administered questionnaire.

Authors: C J Bulpitt; C T Dollery
Journal: Br Med J Date: 1973-09-01

6. Frequency of eye complaints and rashes among patients receiving practolol and propranolol.

Authors: D C Skegg; R Doll
Journal: Lancet Date: 1977-09-03 Impact factor: 79.321

7. Clinical trials of new drugs.

Authors: C T Dollery
Journal: J R Coll Physicians Lond Date: 1977-04

7 in total

19 in total

1. Benefits and harms of drug treatments.

Authors: Jan P Vandenbroucke
Journal: BMJ Date: 2004-07-03

Review 2. Synthesising licensing data to assess drug safety.

Authors: Klim McPherson; Elina Hemminki
Journal: BMJ Date: 2004-02-28

3. A survey of adverse drug reactions in family practice.

Authors: J L Reynolds
Journal: Can Fam Physician Date: 1984-01 Impact factor: 3.275

4. Evaluation of three methods of symptom reporting in a clinical trial of felodipine.

Authors: M A Wallander; E Dimenäs; K Svärdsudd; I Wiklund
Journal: Eur J Clin Pharmacol Date: 1991 Impact factor: 2.953

Review 5. Pharmacovigilance in the pharmaceutical industry.

Authors: J C Talbot; B S Nilsson
Journal: Br J Clin Pharmacol Date: 1998-05 Impact factor: 4.335

6. Monitoring adverse drug reactions: a preliminary study.

Authors: J L Reynolds
Journal: Can Fam Physician Date: 1981-08 Impact factor: 3.275

7. After practolol.

Authors:
Journal: Br Med J Date: 1977-12-17

8. Double-blind comparison of once-daily bopindolol, pindolol and atenolol in essential hypertension.

Authors: W Schiess; D Welzel; R Gugler
Journal: Eur J Clin Pharmacol Date: 1984 Impact factor: 2.953

Review 9. The way towards adverse event monitoring in clinical trials.

Authors: M A Wallander
Journal: Drug Saf Date: 1993-03 Impact factor: 5.606

10. Postmarketing surveillance: practical experience with ketotifen.

Authors: W P Maclay; D Crowder; S Spiro; P Turner
Journal: Br Med J (Clin Res Ed) Date: 1984-03-24