Considerations on what constitutes a 'qualified statistician' in regulatory guidelines.

International regulatory guidelines require that a 'qualified statistician' takes responsibility for the statistical aspects of a clinical trial used for drug licensing. No consensus on what constitutes a 'qualified statistician' appears to have been developed so far. The International Society for Clinical Biostatistics is issuing this reflection paper in order to stimulate a discussion on the concept.

Regulatory advice and drug development--a case study in negotiating with regulators.

Regulatory guidance on the development of drugs has existed for well over half a century in some territories. As drug development grew to become global so was born the need for harmonization. Beginning in the 1990 s, the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) developed guidelines which were adopted by the Food and Drug Administration (FDA) in the U.

The potential for bias in reporting of industry-sponsored clinical trials.

Concerns about potentially misleading reporting of pharmaceutical industry research have surfaced many times. The potential for duality (and thereby conflict) of interest is only too clear when you consider the sums of money required for the discovery, development and commercialization of new medicines. As the ability of major, mid-size and small pharmaceutical companies to innovate has waned, as evidenced by the seemingly relentless decline in the numbers of new medicines approved by Food and Drug Administration and European Medicines Agency year-on-year, not only has the cost per new approved medicine risen: so too has the public and media concern about the extent to which the pharmaceutical industry is open and honest about the efficacy, safety and quality of the drugs we manufacture and sell.

Making available information from studies sponsored by the pharmaceutical industry: some current practices.

Since the web-based registry ClinicalTrials.gov was launched on 29 February 2000, the pharmaceutical industry has made available an increasing amount of information about the clinical trials that it sponsors. The process has been spurred on by a number of factors including a wish by the industry to provide greater transparency regarding clinical trial data; and has been both aided and complicated by the number of institutions that have a legitimate interest in guiding and defining what should be made available.

Proposed best practice for statisticians in the reporting and publication of pharmaceutical industry-sponsored clinical trials.

In this paper we set out what we consider to be a set of best practices for statisticians in the reporting of pharmaceutical industry-sponsored clinical trials. We make eight recommendations covering: author responsibilities and recognition; publication timing; conflicts of interest; freedom to act; full author access to data; trial registration and independent review. These recommendations are made in the context of the prominent role played by statisticians in the design, conduct, analysis and reporting of pharmaceutical sponsored trials and the perception of the reporting of these trials in the wider community.

A randomized controlled trial to compare steroid with cyclosporine for the topical treatment of oral lichen planus.

Objective: To compare the effectiveness of cyclosporine solution versus triamcinolone acetonide in orabase in the treatment of oral lichen planus (OLP) in reducing signs and symptoms.

Study Design: One hundred thirty-nine biopsy-proven OLP patients were randomly assigned to cyclosporine (68) or steroid (71) applied onto the target lesion and affected areas. Assessments were at weeks 0, 2, 4, 8 by clinical scoring and grid measurement of the target lesion (reticulation, erythema, ulceration).

Cardiac arrest and resuscitation epidemiology in Singapore (CARE I study).

Objectives: To describe the epidemiology of out-of-hospital cardiac arrest (OHCA) in Singapore, the emergency medical services (EMS) response, and to identify possible areas for improvement.

Methods: This prospective observational study constitutes phase I of the Cardiac Arrest and Resuscitation Epidemiology (CARE) project. Included were all patients with nontraumatic OHCA conveyed by the national emergency ambulance service.