In the past 25 years, the clinical trial processes for developing new drugs have grown increasingly complex. The nature of the therapies being investigated has increased the difficulty of the procedures being conducted, and competition for trial subjects has resulted in complex multi-centre, multi-regional clinical trials becoming the standard for evaluating medical therapies prior to regulatory approval or as post-registration commitments. In turn, the legal, operational, training, and quality processes have also become more complex due to the increase in the number of sites, site staff, data variables, labs, etc.

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TORONTO, Ontario – On May 3-4, 2006, the MaRS Centre was the venue for the “Innovative Proof-of-Concept Designs for Phase I/II and IIIb Studies” seminar hosted by SciAn Services, Inc. The first of a planned annual event, this particular seminar was undertaken in part to address the FDA’s “diagnosis” of a slowed drug development process, and to bring together members of industry and the academia to discuss the challenges of designing clinical trials. Key speakers on statistical and regulatory topics included Dr. Peter Thall (MD Anderson Cancer Centre), Dr. Chyi-Hung Hsu (Novartis US) and Dr. Agnes Klein (Health Canada).

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One of the most interesting and challenging aspects of early phase clinical trials is studying the pharmacokinetics of a new drug, in order to determine how a body processes it. For those readers with limited knowledge of the subject, this article is intended to provide an overview of pharmacokinetics, and the pharmacokinetic terms that are commonly used in medical journals. The article will also introduce the concepts of bioavailability, therapeutic range, accumulation and steady state, and dose proportionality.

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Why bother using style guides? If you have ever been unsure of the correct way to cite reference material from books, electronic sources or government reports, or whether to use periods in abbreviations, or when to use a a generic drug name instead of a proprietary name, a style guide can provide the answer. Do you really know what an acronym is? See what leading style guides say in the following sections.

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A case report form (CRF) is a data collection tool used in clinical trials to support investigators and coordinators in capturing all protocol-required information. A well-designed CRF facilitates data collection and entry, and directly benefits other facets of data management and statistical analysis. An informative and structured CRF simplifies database design and data validation processes as well as manipulation of data during statistical analysis. This paper explores CRF design techniques that consider efficient data management and statistical analysis.

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The primary objective of phase I studies is to determine the maximum tolerated dose (MTD) which produces a specific level of toxicity. The designs described below can be utilized when MTD needs to be determined in patients, not in healthy volunteers.

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The study was designed as a double-blind, randomized comparison of single doses of Test and Reference treatments to conclude on the equivalence or the superiority of one of the treatments as measured by the clinical outcome variable: "need for repeated intervention".

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TORONTO, Ontario – On May 3-4, 2006, the MaRS Centre was the venue for the “Innovative Proof-of-Concept Designs for Phase I/II and IIIb Studies” seminar hosted by SciAn Services, Inc. The first of a planned annual event, this particular seminar was undertaken in part to address the FDA’s “diagnosis” of a slowed drug development process, and to bring together members of industry and the academia to discuss the challenges of designing clinical trials. Key speakers on statistical and regulatory topics included Dr. Peter Thall (MD Anderson Cancer Centre), Dr. Chyi-Hung Hsu (Novartis US) and Dr. Agnes Klein (Health Canada).

Click to view full article in PDF format.

One of the most interesting and challenging aspects of early phase clinical trials is studying the pharmacokinetics of a new drug, in order to determine how a body processes it. For those readers with limited knowledge of the subject, this article is intended to provide an overview of pharmacokinetics, and the pharmacokinetic terms that are commonly used in medical journals. The article will also introduce the concepts of bioavailability, therapeutic range, accumulation and steady state, and dose proportionality.

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The Joint Meeting of the International Biometric Society (ENAR) was held in Birmingham, Alabama from March 26-29, 1995. This conference consisted of sessions covering various areas of bio-statistics as well as a programme of several continuing education courses. Some of these presentations will be summarized in this article, as well as an overview of the course "Applied Bayesian Statistics".

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Interaction between biologically active agents is of great importance in normal/abnormal phyisiology, toxicology, the control of environmental pollution and in therapeutics. Combination of drugs are often used to achieve better efficacy and/or reduce toxicity in the treatment of abnormal disorders that range from malignancies and severe cardiovascular disease to infections, asthma, diabetes and arthritis. An adequate rationale for treatment with drug combinations is often missing and a trial and error method of screening/evaluating drug combinations is therefore a necessary and potentially rewarding avenue of research. The following paper will introduce our readers to the most frequently used methods in the analysis of drug interactions.

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This article illustrates the use of analysis-of-covariance to explore the association between a covariate and the treatment effect in a 22 cross-over trial. The type I sum of squares is used in the analysis and the results are identical to the 2 separate analyses of covariance presented by Jones and Kenward (1989). An illustration of the analyses based on the example used by Jones and Kenward is presented. Based on the expected mean squares, the appropriateness of the hypothesis tests on the main and interaction effects is discussed.

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Why bother using style guides? If you have ever been unsure of the correct way to cite reference material from books, electronic sources or government reports, or whether to use periods in abbreviations, or when to use a a generic drug name instead of a proprietary name, a style guide can provide the answer. Do you really know what an acronym is? See what leading style guides say in the following sections.

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Quality Assurance is a well established discipline, not least in the healthcare industry where ethical and regulatory considerations require the application of strict quality criteria to the final product delivered to patients. Less often are Quality Assurance criteria applied to more intangible aspects of human endeavour, such as planning and forecasting. We need look no further than government deficit projections to realize that this is a lamentable omission. And deficit financing is not an option for industry.

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As the range of therapeutic products available has expanded, regulatory agency requirements for safety documentation have also grown. Hence, all individuals involved in the process of risk-benefit assessment of investigational and approved drug products need to be familiar with the most frequently encountered drug reactions. This includes investigational site clinical staff as well as clinical research monitors, project managers and safety officers of sponsoring pharmaceutical companies and CRO's working as partners with the pharmaceutical industry.

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A case report form (CRF) is a data collection tool used in clinical trials to support investigators and coordinators in capturing all protocol-required information. A well-designed CRF facilitates data collection and entry, and directly benefits other facets of data management and statistical analysis. An informative and structured CRF simplifies database design and data validation processes as well as manipulation of data during statistical analysis. This paper explores CRF design techniques that consider efficient data management and statistical analysis.

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Data exchange, whether in the form of documents, databases, or other media, has become an essential part of daily business. Additionally, there is a growing need for companies to maintain data in a useable form for an extended period of time, particularly in the pharmaceutical industry.

A new drug application (NDA) to a regulatory agency requires considerable preparation of reports and supporting documentation. This process can result in substantial paper-output, making data and document management an issue for the sponsor and the reviewing regulatory agency.

There is a growing trend for electronic submissions. Such submissions are often referred to as "computer assisted new drug applications", or CANDA. CANDAs address the issues of paperoutput and storage, and also provide a means to facilitate the review process by allowing information contained in reports, appendices and databases to be fully accessible by the regulatory agency. Electronic submissions have appeal since the entire submission can be provided on, for example CD-ROM, and the information can be easily archived.

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An increasing number of pharmaceutical companies and CRO's are turning their attention to groupware technologies (a set of applications which allow a group of people to share information simultaneously; Lotus NotesTM or Microsoft ExchangeTM) to address their information management needs, including clinical study management. In a series of articles, we will review the key characteristics of groupware, the specific requirements of a clinical study management system and its possible extension to incorporate data management. We will assess the feasibility of a distributed data management system which creates the necessary environment for data entry and review to be performed at various study locations, e.g., at investigational sites and/or regional CRO offices.

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In the past 25 years, the clinical trial processes for developing new drugs have grown increasingly complex. The nature of the therapies being investigated has increased the difficulty of the procedures being conducted, and competition for trial subjects has resulted in complex multi-centre, multi-regional clinical trials becoming the standard for evaluating medical therapies prior to regulatory approval or as post-registration commitments. In turn, the legal, operational, training, and quality processes have also become more complex due to the increase in the number of sites, site staff, data variables, labs, etc.

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The pressure to examine the allocation of health care resources has greatly increased in recent years for several reasons, including escalating health care costs, new health care technologies that are increasingly effective, but increasingly expensive, and health care budgets that have been reduced. The above pressures are forcing decision makers to seek new principles for the adoption of new technologies. Consequently, health economics, which studies the economic aspects of health care interventions, has become a rapidly growing field.

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