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Nanospheres of Biodegradable Polymers: A System for Clinical Administration of an Anticancer Drug Paclitaxel (Taxol®)

Paclitaxel (Taxol®) is a diterpenoid extracted from the bark of a rare, slow growing Pacific yew or Western yew tree (Taxus brevifolia). Its antitumour activity was detected in 1967 in the US NCI (National Cancer Institute) screening of cytotoxic agents from natural products and was then found later to...

Pharmacogenetics: Role in Modifying Drug Dosage Regimens

Synder in 1932 wrote the first report on the Mendelian inheritance of the inability to taste phenylthiourea. Twenty-five years later, Arno Motulsky suggested hereditary factors might be the explanation to inter-individual differences in drug responses. This article is available only as a PDF. Please click on “Download PDF” on top...

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 towards medication, which comprise 60% to 90% of all clinical interventions, depending on specialty, have not been systematically studied. This article is available only as a...

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, safety and clinical evaluations of new drugs that have not been approved elsewhere. This article is available only as a PDF. Please click on “Download PDF”...

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 evidence from different samples can be traced back to the early 1900s, when Karl Pearson analysed the preventive effect of serum inoculations against enteric fever. This...

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 effectiveness of treatments on clinical outcomes. Examples of megatrials which successfully recruited more than 10,000 patients include the International Studies of Infarct Survival (ISIS) series...

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” in study design, which enable the question of efficacy of different treatments or managements to be effectively compared. This article is available only as a PDF....

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 needed to ensure novel, effective therapies continue to be approved for clinical use. This article is available only as a PDF. Please click on “Download PDF”...

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 painful series of lists of drugs to learn, the drugs being traditionally classified by functionality and effects. This article is available only as a PDF....

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 the early stages is advisable, and prompt attention to data errors, inconsistencies or missing items on the case record forms (CRFs) is required, so that...

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 of circumstances must occur exclusive of having the disease being investigated and meeting clinical entry criteria. This article is available only as a PDF. Please click...

Estimation of Number of Subjects Required for Comparison of Drug versus Control in Adaptive Designs

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 of different estimators. This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.

The Ethics of Placebo-Controlled Trials in Developing Countries to Prevent Mother-to-Child Transmission of HIV

Placebo-trials on HIV-infected pregnant women in developing countries like Thailand and Uganda have provoked recent controversy. Such experiments aim to find a treatment that will cut the rate of vertical transmission more efficiently than existing ‘gold standard’ treatments like zidovudine. This article is available only as a PDF. Please click...

Evaluating Drugs from Cradle to Grave—Evolving Systems for a Complex Activity

Are medicines dangerous chemicals or life enhancing agents? The answer is ‘Both of those things, often at the same time, and worse in the wrong hands’. This article is available only as a PDF. Please click on “Download PDF” on top to view the full article.