What is historical Aspects of the Internet and Clinical Trials.James M Metz et. al.
Periodic Prompts and Reminders in Health Promotion and Health Behavior Interventions: Systematic Review
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Tutorial
The Internet and Clinical Trials: Background, Online Resources, Examples and Issues
James Paul1,2, MSc, MD; Rachael Seib1,2, MA; Todd Prescott1,2, BSc
1Department of Anesthesia, Hamilton Health Sciences, Hamilton, ON, Canada
2Department of Anesthesia, Faculty of Health Sciences, McMaster University, Hamilton, ON, Canada
Corresponding Author:
James Paul, MSc, MD
Department of Anesthesia
Hamilton Health Sciences
Hamilton General Site
237 Barton St East
Hamilton, ON L8L 2X2
Canada
Phone: +1 905 527 4322 ext 46698
Fax: +1 905 577 8023
Email: james_paul [at] sympatico.ca
ABSTRACT
Both the Internet and clinical trials were significant developments in
the latter half of the twentieth century: the Internet revolutionized
global communications and the randomized controlled trial provided a
means to conduct an unbiased comparison of two or more treatments. Large
multicenter trials are often burdened with an extensive development
time and considerable expense, as well as significant challenges in
obtaining, backing up and analyzing large amounts of data. Alongside the
increasing complexities of the modern clinical trial has grown the
power of the Internet to improve communications, centralize and secure
data as well as to distribute information. As more and more clinical
trials are required to coordinate multiple trial processes in real time,
centers are turning to the Internet for the tools to manage the
components of a clinical trial, either in whole or in part, to produce
lower costs and faster results. This paper reviews the historical
development of the Internet and the randomized controlled trial,
describes the Internet resources available that can be used in a
clinical trial, reviews some examples of online trials and describes the
advantages and disadvantages of using the Internet to conduct a
clinical trial. We also extract the characteristics of the 5 largest
clinical trials conducted using the Internet to date, which together
enrolled over 26000 patients.
(J Med Internet Res 2005;7(1):e5)
doi:10.2196/jmir.7.1.e5
KEYWORDS
Clinical trials; randomized controlled trial; Internet
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Introduction
Both the Internet and clinical trials were significant developments in
the latter half of the 20th century: the Internet revolutionized global
communications and the randomized controlled trial (RCT) provided a
means to conduct an unbiased comparison of two or more treatments. This
paper reviews the historical development of the Internet and the
randomized controlled trial, describes the Internet resources available
that can be used in a clinical trial, reviews some examples of online
trials and describes the advantages and disadvantages of using the
Internet to conduct a clinical trial.
Historical Aspects of the Internet and Clinical Trials
Origins of the Internet
The Internet was born in the 1960s and its applications were initially
limited by the military uses for which it was originally conceived. The
original “Internet” consisted of a cooperative network of four
university computers in the United States (Stanford Research Institute;
University of California, Los Angeles [UCLA]; University of California,
Santa Barbara; and University of Utah) [1]. The development of a
protocol for information distribution in 1990 by Tim Berners-Lee paved
the way for the emergence on the Internet of applications with broader
public appeal [2]. Fifteen years after its inception, the World Wide Web
has become a nearly indispensable tool in education, government,
business, news media and, most important for the purposes of this paper,
medicine and research [3]. Originally designed as an emergency
communications network, the medium evolved from a communications tool
for academics and the military to a medium used for education,
government, business, news media, entertainment, medicine, and research.
The Internet has grown at a phenomenal rate; with over 100 thousand
domains or hosts in 1993 it currently has over 250 million [4]. It is
the first unrestricted uncensored broadcast medium, and under ideal
circumstances (namely, the right location, low traffic volumes and the
right service provider), it can be very cost-effective, because unlike
the telephone system, there is no charge for long-distance service.
Origins of the Randomized Controlled Trial
A clinical trial can be defined as any form of planned experiment
involving patients [5]. The goal of a trial is to discover or verify the
safety and effectiveness of interventions designed to promote wellness
and prevent, diagnose, treat and provide prognosis information about
disease [6]. The essence of a trial is comparison [7]. The comparison is
between a group of patients who receivedtreatment with the intervention
in question and a group of patients who receivedplacebo or another
standard treatment. The modern clinical trial has evolved to include
several features in order to provide reliable and valid results. A good
trial addresses a specific clinical question for which there is
equipoise (an uncertainty as to whether any of the treatments is to be
preferred over the others). It uses a predefined patient population, a
well-defined intervention in comparison with an appropriate control,
predefined outcomes, and a methodology that involves getting informed
consent from participants. Further, a trial involves appropriate
blinding, randomization, and analysis. The inclusion of a control group,
as opposed to historical data, is to ensure that any observed
differences are due to the treatment under investigation and not another
prognostic factor [5]. The purpose of randomization is to balance the
treatment groups for both known and unknown prognostic factors such that
any observed differences in outcome are more likely to be due to
differences between the treatments in question [8]. Hence, randomization
helps to prevent patient selection bias. The purpose of blinding
(patients, investigators, and analysts) is to prevent outcome assessment
bias.
[view this figure] Figure 1. Cumulative number of randomized control
trials (RCTs) versus online RCTs (based on Medline and Old Medline
searches from 1950) on a logarithmic scale over time
Although many examples of clinical investigation can be found throughout
the history of medicine, the RCT emerged in the mid-20th century as the
most powerful and scientifically sound way to establish the efficacy
and safety of medications [9]. Statistician Ronald Fisher introduced the
practice of randomization (randomly assigning study participants to one
or more treatment groups) in horticultural research in 1926 [6]. An
epidemiologist, Austin Bradford Hill, is generally given credit for the
first randomized trial involving humans in 1948 [7]. This trial,
conducted by the Medical Research Council in the United Kingdom,
addressed the question of whether streptomycintherapy and bed rest was
more effective than bed rest alone in treating patients with pulmonary
tuberculosis. In the past few decades the RCT has been increasingly used
as a method to evaluate medical interventions. The Cochrane Controlled
Trials Register (CCTR) is a bibliography of controlled trials generated
from hand searching the world’s medical journals and as of the year 2004
it identified over 415 thousand trials [10]. A recent search of the
PubMed database of the National Library of Medicine in the United States
yielded 65886 controlled clinical trials and 32760 of these were
randomized controlled trials. This represents published trials since the
mid-1960s [11]. Figure 1 illustrates the growth of RCTs. The increasing
pace of RCT research is reflected by the fact that it took 21 years
(1948-1969) for the first 1000 trials to be conducted yet thousands of
trials were conducted in 2004 alone.
The Complexity of Modern Clinical Trials
An RCT is conceptually simple, but to plan a protocol for a study,
obtain funding, recruit patients, conduct the trial, and analyze the
data collected require considerable resources. The initial clinical
trials evaluating antibiotic therapy for communicable diseases had the
advantage of large treatment effects–Hill’s trial on streptomycin
therapy demonstrated a 74% risk reduction for mortality [12]. Today,
most interventions investigated in superiority trials are expected to
have a more modest benefit, perhaps a 10% to 20% risk reduction for an
important outcome [6]. In order to investigate these more modest
treatment effects it is necessary for modern trials to be carefully
designed so that both systematic and random error are minimized, as
differences of this magnitude cannot be detected reliably against a
background noise of chance or other influences. Systematic error is
minimized with a well-designed protocol that avoids bias, and random
error is avoided by studying a large enough sample size [13]. Sample
size is of particular importance in the conduct of equivalence trials.
Equivalence trials, in contrast to superiority trials, are designed to
establish no difference in efficacy between two interventions. However,
in order to show equal efficacy, equivalence trials usually will require
a 10% larger sample size in comparison with conventional superiority
trials [14]. In order to achieve a sufficient sample size in a
reasonable time, many trials recruit patients from multiple centers
across several geographical entities (eg, cities, countries) [6]. These
multicenter trials require infrastructure which is accomplished with a
central coordinating center that usually handles the recruitment of
study centers, the randomization of patients, any necessary laboratory
analysis of patient samples, data collection, data analysis, and quality
control [15].
Internet Resources Applied to the Clinical Trial
Although the complexity of modern clinical trials is unlikely to change
in the future, using Internet resources may reduce the expense and
development time of a clinical trial. The Internet has many features
that are useful in the conduct of a clinical trial. For instance,
funding information and tools for developing a trial protocol are
available online; and the processes of patient registration,
randomization, data collection, analysis, and publication can all be
accomplished with online resources. The Internet is also an ideal
vehicle for the dissemination of information, and in this respect may
facilitate the ease and rapidity with which the findings of a trial are
translated into clinical practice. Table 1 summarizes a selection of
Internet resources for conducting a clinical trial.
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