Clinical research after drug approval: What is needed and what is not

Drug Information Journal

Volumn 33, Issue 2, 1999, Pages 627-634

  Decoster, Genevieve ^a   Buyse, Marc ^b  

^a F HOFFMANN LA ROCHE LTD   (Switzerland)

^b INTERNATIONAL DRUG DEVELOPMENT INSTITUTE   (Belgium)

Author keywords

Clinical trial design; Good clinical practice; Phase IV studies; Postregistration studies

Indexed keywords

CLINICAL RESEARCH; DRUG APPROVAL; DRUG EFFICACY; DRUG RESEARCH; DRUG SAFETY; GOOD CLINICAL PRACTICE; METHODOLOGY; PRIORITY JOURNAL; REVIEW;

EID: 0032967002     PISSN: 00928615     EISSN: None     Source Type: Journal    
DOI: 10.1177/009286159903300232     Document Type: Review

References (41)

1. CPMP/ICH/135/95. European Agency for the Evaluation of Medicinal Products Human Medicines Evaluation Units. Effective January 17, 1997.
2. Japan's New GCP and other Rules on Clinical Trials. Japanese Technical Requirements for New Drug Registration 1997. Yakuji Nippo, Ltd.; 1997.
3. WHO guidelines for good clinical practice (GCP) for trials on pharmaceutical products. Geneva: World Health Organization; Feb 1, 1994.
4. 21 CFR (Code of Federal Regulations) parts 50, 56, 312, 214, National Archives and Records Administration. Revised as of April 1, 1997.
5. Spilker B. Marketing studies. Drug News Perspect. 1990;3(6):369-371.
6. Witte PU. Postmarketing observational studies and phase IV trials in Germany. Appl Clin Trials. 1993; 2(7):54-60.
7. Venulet J. Potential role of postmarketing research. Drug Exptl Clin Res. 1987;XIII:673-683.
8. Toscani MR, Resnick G. Postmarketing studies: methods for implementation and potential use of data. Drug Inf J. 1992;26:261-265.
9. Bell RL, O'Brian Smith E. Clinical trial in postmarketing surveillance of drugs. Contr Clin Trials. 1982;3:61-68.
10. Edlavitch SA. Postmarketing surveillance methodologies. Drug Intel Clin Pharm. 1988;22:68-78.
11. Ellenberg SS, Finkelstein DM, Schoenfeld DA. Statistical issues arising in AIDS clinical trials. J Am Stat Assoc. 1992;87:562-569.
12. Cocchetto DM, Jones DR. Faster access to drugs for serious or life-threatening illnesses through use of the accelerated approval regulation in the United States. Drug Inf J. 1998;32:27-35.
13. Hakkaraien H, Hattab JR, Venulet J. Phase IV research by pharmaceutical companies. Pharmacopsychiat. 1984;17:168-176.
14. Ray WA, Griffin MR, Avorn J. Evaluating drugs after their approval for clinical use. N Engl J Med. 1993;329:2029-2032.
15. Kass Wenger N. Why community physicians should encourage their patients to participate in randomized clinical trials. Circulation. 1978;58:963-964.
16. ISIS - 2 (Second International Study of Infarct Survival) Collaborative Group. Randomized trial of intravenous streptokinase, oral aspirin, both, or neither among 17,187 cases of suspected acute myocardial infarction. Lancet. 1988;ii:349-360.
17. Yusuf S, Collins R, Peto R, et al. Intravenous and intracoronary fubrinolytic therapy in acute myocardial infarction: overview of results on mortality, reinfarction and side-effects from 33 randomized controlled trials. Eur Heart J. 1985;6:556-585.
18. GISSI (Gruppo Italiano per la Studio dela Streptochinasi Nell-Infarcto Miocardico). Effectiveness of intravenous thrombolytic treatment in acute myocardial infarction. Lancet. 1986;ii:397-401).
19. Royal RM. Ethics and statistics in randomized clinical trials (with discussion). Stat Sci. 1991;6:52-88.
20. Antman EM, Lau J, Kupelnick B, et al. A comparison of results of meta-analysis of randomized control trials and recommendations of clinical experts. JAMA. 1992;268:240-248.
21. Buyse M, Poplavsky JL. Clinical evaluation of virus safety and inhibitor incidence: statistical considerations. Blood Coagul Fibrinol. 1995;6 (Suppl.2): S86-S92.
22. Waldron HA, Cookson RF. Avoiding the pitfalls of sponsored multicentre research in general practice. Br Med J. 1993;307:1351-1354.
23. Buyse M. Potential and pitfalls of randomized clinical trials in cancer research. Cancer Surveys. 1989; 8:91-105.
24. Strom BL, Miettinen OS, Melmon KL. Postmarketing studies of drug efficacy: when must they be randomized? Clin Pharmacol Ther. 1983;34:1-7.
25. Byar DP, Schoenfeld DA, Green SB, et al. Design considerations for AIDS trials. N Engl J Med. 1990;323:1343-1348.
26. Tognoni G, Alli C, Avanzini F, et al. Randomised clinical trials in general practice: lessons from a failure. Br Med J. 1991;303:969-971.
27. Lamas GA, Pfeffer MA, Hamm P, et al. Do the results of randomized clinical trials of cardiovascular drugs influence medical practice? N Engl J Med. 1992;327:241-247.
28. Boissel JP. Impact of randomized clinical trials on medical practice. Contr Clin Trials. 1989;4:120S-134S.
29. Peto R, Collins R, Gray R. Large-scale randomized evidence: Large, simple trials and overview of trials. J Clin Epidemiol. 1995;48:23-40.
30. Buyse M. The case for loose inclusion criteria in clinical trials. Acta Chir Belg. 1990;90:129-131.
31. Yusuf S, Held P, Teo KK, Toretsky ER. Selection of patients for randomized controlled trials: implications of wide or narrow eligibility criteria. Stat Med. 1990;9:73-86.
32. Stenning S. The "uncertainty Principle" selection of patients for cancer clinical trials. In: Introducing new treatments for cancer. Williams CJ, ed. New York: John Wiley; 1992.
33. Temple R. Government viewpoint of clinical trials of cardiovascular drugs. Med Clinics N Am. 1989; 73:495-509.
34. Fleming TR. Treatment evaluation in active control studies. Cancer Treat Rep. 1987;71:1061-1065.
35. Makuch RW, Pledger G, Hall DG, et al. Active control equivalence studies. In: Statistical Issues in Drug Research and Development. Pearce KE, ed. New York: Marcel Dekker; 1992.
36. ICH Harmonised Tripartite Guideline for Good Clinical Practice. Brookwood Medical Publications; 1996.
37. Brown L. Implementation of ICH GCP. GCP J. 1998:5;11-14.
38. Buyse M. Regulatory vs public health requirements in clinical trials. Drug Inf J. 1993;27:977-984.
39. Jefferys DB. Good Clinical Practice: EC expectations, education, self-regulation, or imposition? Drug Inf J. 1992;26:609-613.
40. ISIS-3 (Second internal study of infarct survival) Collaborative group. ISIS-3: a randomized comparison of streptokinase vs tissue plasminogen activator vs anitreplase and of aspirin plus heparin vs aspirin alone among 41,299 cases of suspected acute myocardial infarction. Lancet. 1992;339:753-770.
41. CPMP Working Party on Pharmacovigilance. Draft guideline for marketing authorization holders on company-sponsored post-marketing safety studies. III/3176/93, 1993.