19-01-2013, 11:26 AM
MANAGEMENT OF DATA IN CLINICAL TRIALS
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INTRODUCTION
Clinical trials are utilized in many clinical specialties to test the effi cacy of a
specifi c treatment or intervention in a group of patients/subjects, and inferences
are then drawn about the use of the treatment in the general population.
There are different types or phases of clinical trials, but they all have one
common feature. The results that are reported at the end of the trial are only
as good as the quality of the data collected and analyzed as part of the trial.
A “ good ” result of a clinical trial is a result that provides the correct answers
to the questions asked, not necessarily one that is positive or statistically
signifi cant.
Good data management practices are essential to any clinical trial, yet this
area is one that can be neglected during the planning stages of a trial. This
book discusses the various stages of the life of a trial from planning to analysis,
and it focuses on the management of the data during each stage.
Clinical trials can be large or small; they can involve one clinical center or
multiple centers. Multicenter trials allow more rapid accrual of patients to a
trial, and therefore the answers to the questions being asked are available
more quickly. The results of multicenter trials are also more easily generalized
to the population as a whole because the trial includes patients from a variety
of settings, rather than just a single site. Large multicenter trials usually have a
Coordinating Center with a wide range of responsibilities, including input in trial
design, quality control and computerization of trial data, interim and fi nal analyses
of the data, and preparation of a report on the results.
DEFINITION OF A CLINICAL TRIAL
Throughout this book, a clinical trial is defi ned as a trial involving the assessment
of one or more regimens used in treating or preventing a specifi c illness
or disease. The regimen may be curative, palliative, or preventive. There are
other types of clinical studies, some involving the administration of questionnaires,
surveys, or specifi c tests to subjects who fulfi ll certain requirements.
These studies collect information on the subjects entered, but do not assess
the effi cacy of interventions. Many of the guidelines for therapeutic trials apply
equally to these kinds of studies. For the most part, in this book, examples and
terminology will refer to therapeutic trials, but parallels may be drawn for
other types of studies.
DEVELOPMENT OF A CLINICAL TRIAL
A clinical trial goes through various stages from the development of the
hypothesis to be tested, to the analysis of the results. In very broad terms, the
three stages of a clinical trial are:
• Design and development
• Patient accrual and data collection
• Follow - up and analysis
In each of the three stages, consideration must be given to systems for managing
the data. These three stages will be covered extensively in subsequent
chapters, but this outline of each will provide the reader with a general overview
of each stage.
Design and Development
During the design and development stage of a trial, a protocol document is
developed. The protocol contains critical information for the participants in
the trial. Sections usually found in a protocol include:
• Scientifi c rationale for the trial
• Defi nition of the patient population