Case Study 5fu Plus Leucovorin In Colon Cancer

As is clear, the history of clinical trials in GI cancer is long and has been very successful. As an example illustrating several facets of both the past history of GI clinical trials and issues that will likely be faced again in future studies, here we present a case study of the development, establishment and replacement of what was once the US standard of care for advanced colorectal cancer and, as of 2002, remains the standard for adjuvant stage 3 colon cancer, the 'Mayo Clinic' bolus...

Gynaecology And Infertility

A potential problem that can occur with randomised controlled trials is where the intervention is not targeted at individual patients, but at groups of patients. This can happen where the intervention is an information package for the management of menorrhagia in primary care9 or a clinical guideline for the management of infertility.10 In these studies, randomising patients to receive management using the information package or clinical guidelines would have introduced contamination, since GPs...

Psychiatric Treatments And Their Evaluation The 1950s Onwards

Kopeloff and Cheney's study of removal of focal infections as a treatment for particular forms of mental illness has many aspects of a modern clinical trial, although it is missing that most essential component, random allocation. Kopeloff and Cheney decided themselves in regard to each patient whether they should be operated on or whether they should be a control. It was Fisher who recognised the need for randomisation to treatment groups in medical, biological and agricultural experiments,...

Historical Perspective On Clinical Trials In Breast Cancer

Scientific understanding of the biology of breast cancer has changed radically in the past 50 years. Results of large randomised trials have played a major role in this transition. From the nineteenth century and up into the 1970s, breast cancer was understood to be a local regional disease that spread by direct extension along lymphatic pathways to distant sites. This concept gave rise to the surgical methods promoted by W.S. Halsted14-16 around the turn of the twentieth century, i.e.,...

References

Committee for Proprietary Medicinal Products (CPMP). Clinical investigation of steroid contraceptives in women. The European Agency for the Evaluation of Medicinal Products (2000). 2. Van Look PFA, Perez-Palacios G. Contraceptive Research and Development 1984 to 1994. Oxford Oxford University Press (1994). 3. Rabe T, Runnebaum B. Fertility Control - Update and Trends. Berlin Springer-Verlag (1999). 4. Trussell J, Kost K. Contraceptive failure in the United States a critical review of the...

Clinical Trials Methods

In dental research, the clinical trials methods used mainly follow those developed and adopted in medical research. The basic design principles and considerations are very similar, thus the following discussion on clinical trials methods can be kept short and precise for general areas, with specific areas unique in dentistry discussed in more detail. A few references on clinical trial methodology and some from the dental literature are recommended for general reading.1417 As with the...

Adaptive Designs Of Clinical Trials

Adaptive designs have the dual goals of efficient learning from all relevant results and effective treatment of patients. They are more flexible than conventional designs, and have application in all phases of drug development. Such designs can be implemented using Bayesian methodology as a means to incorporate new information into the trial design. Designs of clinical trials for breast cancer are usually static in the sense that the sample size and any prescription for assigning treatment,...

Phase Iii Studies

Most drugs for obstructive airway diseases are given for maintenance treatment, and the main point to document is the level of disease control of the proposed treatment. At the same time it is important to document the adverse event profile, since most of the drugs in this therapeutic area are considered very safe, and safety must not be an issue of a new drug. Thus the pivotal confirmatory trials for the airway diseases asthma, COPD and rhinitis are parallel group, diary card studies typically...

Skin Disorders And Clinical Trial Methods Adapting Study Design To Setting And Disease

As for other disciplines, the last few decades have seen an impressive increase in the number of clinical trials carried out in dermatology. However, there are indications that the upsurge of clinical research has not been paralleled by a refinement in clinical trial methodology and the quality of randomised control trials (RCTs) in dermatology falls well below the usually accepted standards.1315 In this section we would like to mention some issues which deserve special attention when designing...