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Frequently Asked Questions about Clinical Trials
What is a clinical trial?*
A clinical trial is a research study to answer specific questions about a new medical treatment
(medicine/drug, medical device, new therapies, vaccines), or new ways of using
known treatments. Clinical trials (also called medical research and research
studies) are used to determine whether such new treatments are both safe and
effective. Carefully conducted clinical trials are the fastest and safest way to
find treatments that work in people.
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Why participate in a clinical trial?*
Participants in clinical trials can play a more active role in their own healthcare, gain access to new
research treatments before they are widely available, and help others by
contributing to medical research.
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Where do the ideas for trials come from?*
Ideas for clinical trials usually come from researchers. After researchers have
tested new therapies or
procedures in the laboratory and in animal studies (preclinical studies), the
treatments with the most promising laboratory results progress into clinical
trials. By conducting clinical trials, more and more information is gained about
a new treatment, its risks and how well it may or may not work.
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Who sponsors clinical trials and where are they conducted?*
Clinical trials are sponsored or funded by a variety of organizations or individuals such as
physicians, medical institutions, foundations, voluntary groups, and
pharmaceutical companies. Trials can take place in a variety of locations, such
as hospitals, universities, doctors' surgeries, or community clinics.
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What is a protocol?*
A protocol is a study plan specific to each clinical trial. The plan is carefully designed to
safeguard the health of the participants as well as answer specific research
questions. A protocol describes what types of people may participate in the
trial; the schedule of tests, procedures, medications, and dosages; and the
length of the study. While in a clinical trial, participants following a
protocol are seen regularly by the research staff to monitor their health and to
determine the safety and effectiveness of their treatment.
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What is a placebo?*
A placebo us an inactive pill, liquid, or powder that has no treatment value. In clinical trials,
experimental treatments are often compared with placebos to assess the
treatment's effectiveness. In some studies, the participants in the control
group will receive a placebo instead of an active drug or treatment.
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What is a control or control group?*
A control is the standard by which experimental treatments are evaluated. In many clinical trials, one
group of patients will be given an experimental drug or treatment, while the
control group is given either a standard treatment for the illness or a placebo.
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What are the different types of clinical trials?*
Interventional trials (also called
treatment trials) determine whether new treatments, new combinations
of drugs, new ways of using known therapies or new approaches to surgery or
radiation therapy are safe and effective. These trials might ask a participant
to take an experimental new drug or undergo surgery.
Prevention trials look for better ways to prevent disease in people who have never had the disease or
to prevent a disease from returning. These approaches may include medicines, vaccines, vitamins, minerals, or lifestyle changes.
Observational trials address health issues in large groups of people. Trial participants may be asked
to answer questions about their family histories or give blood samples, but they
do not receive treatment for their diseases.
Screening trials test the best way to detect certain diseases or health conditions.
Quality of Life trials (or Supportive Care trials) explore ways to improve comfort and the quality of
life for individuals with a chronic illness.
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What is Boehringer Ingelheim's engagement and commitment?
As an innovative pharmaceutical company, Boehringer
Ingelheim has a large and experienced global team managing and conducting
clinical trials in many indications around the world. Such trials are conducted
to establish the potential of drugs under investigation to progress to becoming
new medicines. With these trials we evaluate the safety, tolerability and efficacy of drugs.
They are
fundamental to developing novel treatments of therapeutic benefit.
Patient safety is the prime concern of Boehringer Ingelheim when designing
clinical trials. Our trials are conducted according to agreed international
standards and in compliance with all respective regulations. All patients
who enter into our clinical trials are fully informed about potential risks and
the benefits of their involvement and are free to
withdraw their consent or discontinue participation at any time with no
need for justification.
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What are the phases of clinical trials?
In clinical trials the effects of drugs under investigation are typically
compared to that of placebos, which have no pharmaceutical impact, or with
comparable drugs already on the market. Clinical trials are allocated to four
main clinical development phases.
Phase I
trials study the safety and tolerability of drugs in healthy volunteers.
These trials
also provide information on the degree and time course of absorption,
distribution in the body, metabolic breakdown and excretion of the compound
under investigation. These effects are studied at various dosage levels. This
phase also seeks to identify whether the new drug interacts with food or other
drugs and could reduce or increase the effects of medications taken
simultaneously. Phase I trials include normally 20 to 50 volunteers and
treatment duration generally ranges from single dose
to multiple doses and from a few minutes up
to
two
weeks.
Phase II
trials involve patients with the specific illnesses which are targeted by
the drug
under investigation. These studies, which continue to evaluate drug safety, aim
to establish the proof that a new drug is clinically effective in the
treatment of the particular disease and what the appropriate drug doses should
be. These trials may also result in unanticipated discoveries of treatment for
other diseases. Phase II trials can include up to a few hundred
patients and treatment duration normally does not exceed three months.
Phase III
trials, which only proceed when phase II results have established the proof of
concept for short term efficacy and safety for patients. During Phase III trials substantial
evidence of the safety and efficacy of drugs under investigation is produced in large
patient populations over extended time periods. The regulatory authorities for
pharmaceuticals are provided with all information from these trials to enable
them to determine whether the drug can be marketed as medicine. Phase III trials
include as many as several thousand patients and treatment durations can be up to one year
or
longer.
Phase IV
trials, typically continue to investigate a drug after
its initial approval from the regulatory authorities. In this phase the focus is
on further evaluation of the use for which approval was secured, for comparison to or combination with other established drugs and to
generate more data on safety under broader use. Phase IV trials are an important
tool to strengthen the understanding of the drug and to give guidance to prescribers and patients on the safe and appropriate use under various clinical
conditions. Regulatory authorities can also request such trials to seek answers
to particular issues. Phase IV trials are by definition always performed in the
approved indication. They can be both small and
also extremely large ( 10-30,000 patients).
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* source: based on clinicaltrials.gov, cancer.gov and ich.org
FAQs of 20 July 2005 as provided by
IFPMA
© 2005 - 2007 Boehringer Ingelheim International GmbH, Germany. All rights reserved.
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