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Post-Release Drug Treatment Risks: Strategies to Minimise Harm to Patients
Physicians have long accepted unreliable evaluations of the risks attached to pharmacotherapy, i.e. treating our patients with drugs. The reasons for the uncritical attitude...
Clinical Drug Evaluation: The Regulatory Perspectives
Evaluating new drugs for marketing approval is a highly specialised and knowledge-intensive activity. This is especially so if the intention is to conduct quality,...
Meta-analyses of Clinical Drug Trials—Gold Standard Reviews or Statistical Alchemy?
Informal review and synthesis of scientific evidence has been practised for as long as experiments have been replicated. The idea of quantitatively combining the...
Megatrials of Drug Treatments: Strengths and Limitations
A “megatrial” is a very large randomised controlled clinical trial (RCT) recruiting many thousands of patients from many centres in order to assess the...
Clinical Drug Trials: Practical Problems of Phase III
There has been a rapid increase in clinical trial activity in Singapore and other parts of Asia. Randomised clinical trials are the “gold standard”...
Design of Phase I and II Clinical Trials in Oncology and Ethical Issues Involved
Drug development is costly and time-consuming in terms of economic, patient and research resources. An integrated effort involving academia, industry, and regulatory authorities is...
Clinical Drug Development—Practical Issues in Clinical Pharmacology Studies
Clinical pharmacology (CP) as a discipline comes in many guises. The perception for a medical student, and for many doctors, may be that of...
A Review of Software for Data Management, Design and Analysis of Clinical Trials
In clinical trials, subjects are usually entered one at a time, and their responses to treatment monitored sequentially. Regular monitoring of trial progress during...
Assessment of Patient Sociodemographic Variables in Clinical Trials—Can Patient Characteristics Make a Difference?
The pathway by which patients enter clinical trials can be a selective, non-random process. In order for patients to enter clinical trials, a set...
Estimation of Number of Subjects Required for Comparison of Drug versus Control in Adaptive...
Traditional designs for clinical trials make balanced (or 50-50) allocation of patients to treatments. This is done in the past to minimise the variance...