Abstract
Most randomised clinical trials of cancer treatment include a few hundred patients or less. Recent statistical papers advocate that sometimes thousands of patients should be entered. In this paper I show that for certain types of cancer trials the 'thousands policy' is not required while for others it is desirable but not feasible. In the latter case other strategies should be considered, such as two-stage phase III studies or parallel studies leading to overviews. There is, however, an important subset of trials for which application of the thousands policy is both necessary and feasible. The key to progress lies partly in the achievement of greater recruitment rates in trails of common cancers and partly in greater inter-group collaboration.
Full text
PDF
Selected References
These references are in PubMed. This may not be the complete list of references from this article.
- Baum M. Endoscopic coagulation of upper gastrointestinal haemorrhage, one; randomised clinical trials, two. Br Med J (Clin Res Ed) 1987 Jul 18;295(6591):212–213. doi: 10.1136/bmj.295.6591.212-a. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Byar D. P. Proceedings: The Veterans Administration Cooperative Urological Research Group's studies of cancer of the prostate. Cancer. 1973 Nov;32(5):1126–1130. doi: 10.1002/1097-0142(197311)32:5<1126::aid-cncr2820320518>3.0.co;2-c. [DOI] [PubMed] [Google Scholar]
- Cortes E. P., Holland J. F., Wang J. J., Sinks L. F., Blom J., Senn H., Bank A., Glidewell O. Amputation and adriamycin in primary osteosarcoma. N Engl J Med. 1974 Nov 7;291(19):998–1000. doi: 10.1056/NEJM197411072911903. [DOI] [PubMed] [Google Scholar]
- Eilber F. R., Grant T., Morton D. L. Adjuvant therapy for osteosarcoma: preoperative and postoperative treatment. Cancer Treat Rep. 1978 Feb;62(2):213–216. [PubMed] [Google Scholar]
- Ellenberg S. S., Eisenberger M. A. An efficient design for phase III studies of combination chemotherapies. Cancer Treat Rep. 1985 Oct;69(10):1147–1154. [PubMed] [Google Scholar]
- Jaffe N., Frei E., 3rd, Traggis D., Bishop Y. Adjuvant methotrexate and citrovorum-factor treatment of osteogenic sarcoma. N Engl J Med. 1974 Nov 7;291(19):994–997. doi: 10.1056/NEJM197411072911902. [DOI] [PubMed] [Google Scholar]
- Link M. P., Goorin A. M., Miser A. W., Green A. A., Pratt C. B., Belasco J. B., Pritchard J., Malpas J. S., Baker A. R., Kirkpatrick J. A. The effect of adjuvant chemotherapy on relapse-free survival in patients with osteosarcoma of the extremity. N Engl J Med. 1986 Jun 19;314(25):1600–1606. doi: 10.1056/NEJM198606193142502. [DOI] [PubMed] [Google Scholar]
- Peto R. Why do we need systematic overviews of randomized trials? Stat Med. 1987 Apr-May;6(3):233–244. doi: 10.1002/sim.4780060306. [DOI] [PubMed] [Google Scholar]
- Rosen G., Nirenberg A., Caparros B., Juergens H., Kosloff C., Mehta B. M., Marcove R. C., Huvos A. G. Osteogenic sarcoma: eight-percent, three-year, disease-free survival with combination chemotherapy (T-7). Natl Cancer Inst Monogr. 1981 Apr;(56):213–220. [PubMed] [Google Scholar]
- Theological interference in medicine. Lancet. 1978 Sep 16;2(8090):623–623. [PubMed] [Google Scholar]
- Tolley D. A., Hargreave T. B., Smith P. H., Williams J. L., Grigor K. M., Parmar M. K., Freedman L. S., Uscinska B. M. Effect of intravesical mitomycin C on recurrence of newly diagnosed superficial bladder cancer: interim report from the Medical Research Council Subgroup on Superficial Bladder Cancer (Urological Cancer Working Party). Br Med J (Clin Res Ed) 1988 Jun 25;296(6639):1759–1761. doi: 10.1136/bmj.296.6639.1759. [DOI] [PMC free article] [PubMed] [Google Scholar]
- Yusuf S., Collins R., Peto R. Why do we need some large, simple randomized trials? Stat Med. 1984 Oct-Dec;3(4):409–422. doi: 10.1002/sim.4780030421. [DOI] [PubMed] [Google Scholar]