Skip to main content
PMC home page
The BMJ logoLink to The BMJ
. 1995 May 20;310(6990):1305–1306. doi: 10.1136/bmj.310.6990.1305

Registration of drugs for treating cancer and HIV infection: a plea to carry out phase 3 trials before admission to the market.

P P Koopmans 1
PMCID: PMC2549681  PMID: 7773046

Abstract

Drugs for cancer and HIV infection tend to be admitted to the market on the basis of results from phase 2 trials. Assessing the benefit-risk balance with phase 2 trials often is difficult--the effect of the drug is usually temporary; the correlation between response or improvement of clinical measurements and the patient's wellbeing is often poor; and the side effects of drugs for these fatal diseases are serious. Therefore, although sometimes difficult to conduct, comparative trials that use standard treatment, placebos, or best supportive care remain the cornerstone for reliably assessing the benefit-risk balance.

Full text

PDF

Selected References

These references are in PubMed. This may not be the complete list of references from this article.

  1. A trial of disputation. Lancet. 1994 Jan 1;343(8888):1–2. [PubMed] [Google Scholar]
  2. AIDS, ethics, and clinical trials. Institute of Medical Ethics Working Party on the Ethical Implications of AIDS. BMJ. 1992 Sep 19;305(6855):699–701. doi: 10.1136/bmj.305.6855.699. [DOI] [PMC free article] [PubMed] [Google Scholar]
  3. Atzpodien J., Körfer A., Franks C. R., Poliwoda H., Kirchner H. Home therapy with recombinant interleukin-2 and interferon-alpha 2b in advanced human malignancies. Lancet. 1990 Jun 23;335(8704):1509–1512. doi: 10.1016/0140-6736(90)93039-r. [DOI] [PubMed] [Google Scholar]
  4. Beutler E. Cladribine (2-chlorodeoxyadenosine) Lancet. 1992 Oct 17;340(8825):952–956. doi: 10.1016/0140-6736(92)92826-2. [DOI] [PubMed] [Google Scholar]
  5. Byrne M. Cancer chemotherapy and quality of life. BMJ. 1992 Jun 13;304(6841):1523–1524. doi: 10.1136/bmj.304.6841.1523. [DOI] [PMC free article] [PubMed] [Google Scholar]
  6. Coates A., Gebski V., Bishop J. F., Jeal P. N., Woods R. L., Snyder R., Tattersall M. H., Byrne M., Harvey V., Gill G. Improving the quality of life during chemotherapy for advanced breast cancer. A comparison of intermittent and continuous treatment strategies. N Engl J Med. 1987 Dec 10;317(24):1490–1495. doi: 10.1056/NEJM198712103172402. [DOI] [PubMed] [Google Scholar]
  7. Groopman J. E., Scadden D. T. Interferon therapy for Kaposi sarcoma associated with the acquired immunodeficiency syndrome (AIDS) Ann Intern Med. 1989 Mar 1;110(5):335–337. doi: 10.7326/0003-4819-110-5-335. [DOI] [PubMed] [Google Scholar]
  8. Lagakos S. W., Hoth D. F. Surrogate markers in AIDS: where are we? Where are we going? Ann Intern Med. 1992 Apr 1;116(7):599–601. doi: 10.7326/0003-4819-116-7-599. [DOI] [PubMed] [Google Scholar]
  9. Moertel C. G. Chemotherapy for colorectal cancer. N Engl J Med. 1994 Apr 21;330(16):1136–1142. doi: 10.1056/NEJM199404213301608. [DOI] [PubMed] [Google Scholar]
  10. Rothman K. J., Michels K. B. The continuing unethical use of placebo controls. N Engl J Med. 1994 Aug 11;331(6):394–398. doi: 10.1056/NEJM199408113310611. [DOI] [PubMed] [Google Scholar]
  11. Scheithauer W., Rosen H., Kornek G. V., Sebesta C., Depisch D. Randomised comparison of combination chemotherapy plus supportive care with supportive care alone in patients with metastatic colorectal cancer. BMJ. 1993 Mar 20;306(6880):752–755. doi: 10.1136/bmj.306.6880.752. [DOI] [PMC free article] [PubMed] [Google Scholar]
  12. Souquet P. J., Chauvin F., Boissel J. P., Cellerino R., Cormier Y., Ganz P. A., Kaasa S., Pater J. L., Quoix E., Rapp E. Polychemotherapy in advanced non small cell lung cancer: a meta-analysis. Lancet. 1993 Jul 3;342(8862):19–21. doi: 10.1016/0140-6736(93)91882-m. [DOI] [PubMed] [Google Scholar]
  13. Tobias J. S. Cancer of the head and neck. BMJ. 1994 Apr 9;308(6934):961–966. doi: 10.1136/bmj.308.6934.961. [DOI] [PMC free article] [PubMed] [Google Scholar]
  14. Trimble E. L., Adams J. D., Vena D., Hawkins M. J., Friedman M. A., Fisherman J. S., Christian M. C., Canetta R., Onetto N., Hayn R. Paclitaxel for platinum-refractory ovarian cancer: results from the first 1,000 patients registered to National Cancer Institute Treatment Referral Center 9103. J Clin Oncol. 1993 Dec;11(12):2405–2410. doi: 10.1200/JCO.1993.11.12.2405. [DOI] [PubMed] [Google Scholar]

Articles from BMJ : British Medical Journal are provided here courtesy of BMJ Publishing Group

RESOURCES