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Rules and principles for Clinical trials were first
introduced in Avicenna's The Canon of Medicine in 1025 AD,
which still form the basis of modern clinical trials:
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"The drug must be free from any extraneous
accidental quality."
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"It must be used on a simple, not a composite,
disease."
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"The drug must be tested with two contrary types of
diseases, because sometimes a drug cures one disease by
its essential qualities and another by its accidental
ones."
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"The quality of the drug must correspond to the
strength of the disease. For example, there are some
drugs whose heat is less than the coldness of certain
diseases, so that they would have no effect on them."
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"The time of action must be observed, so that essence
and accident are not confused."
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"The effect of the drug must be seen to occur constantly
or in many cases, for if this did not happen, it was an
accidental effect."
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"The experimentation must be done with the human body,
for testing a drug on a lion or a horse might not prove
anything about its effect on man."
Coordination between Europe, Japan and the United States
led to a joint regulatory-industry initiative on
international harmonization named after 1990 as the
International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for
Human Use (ICH) ICH HARMONISED TRIPARTITE GUIDELINE. The
guidelines are continuously being updated and are have
open excess to all at http://www.ich.org/cache/compo/276-254-1.html
Following are some common terms used in clinical trials.
ADVERSE REACTION: (Adverse Event.) An unwanted effect
caused by the administration of drugs. Onset may be sudden
or develop over time.
CLINICAL: Pertaining to or founded on observation and
treatment of participants, as distinguished from theoretical
or basic science.
CLINICAL INVESTIGATOR/ Principal Investigator: A medical
researcher in charge of carrying out a clinical trial's
protocol. Sub Investigator: A medical researcher assisting
the PI.
CLINICAL TRIAL: A clinical trial is a research study to
answer specific questions about vaccines or new therapies or
new ways of using known treatments. Clinical trials (also
called medical research and research studies) are used to
determine whether new drugs or treatments are both safe and
effective. Carefully conducted clinical trials are the
fastest and safest way to find treatments that work in
people. Trials are in four phases: Phase I –IV.
COMMUNITY-BASED CLINICAL TRIAL (CBCT): A clinical trial
conducted primarily through primary-care physicians rather
than academic research facilities.
COMPASSIONATE USE: A method of providing experimental
therapeutics prior to final FDA approval for use in humans.
This procedure is used with very sick individuals who have
no other treatment options. Often, case-by-case approval
must be obtained from the FDA for "compassionate use" of a
drug or therapy.
COMPLEMENTARY AND ALTERNATIVE THERAPY: Broad range of
healing philosophies, approaches, and therapies that Western
(conventional) medicine does not commonly use to promote
well-being or treat health conditions. Examples include
acupuncture, herbs, etc.
CRA: A clinical research associate ensures compliance
with the clinical trial protocol, checks clinical site
activities, makes on-site visits, reviews Case Report Forms
(CRFs) and communicates with clinical research
investigators. A clinical research associate is usually
required to possess an academic degree in Life Sciences and
needs to have a good knowledge of Good clinical practice and
local regulations.
CASE REPORT FORM: A Case Report Form (or CRF) is a paper or
electronic questionnaire specifically used in clinical trial
research. The Case Report Form is the tool used by the
sponsor of the clinical trial to collect data from each
participating site. All data on each patient participating
in a clinical trial are held and/or documented in the CRF,
including adverse events
CRO: A Contract Research Organization (CRO) is a service
organization that provides support to the
pharmaceutical/biotech industry in the drug and medical
device research & development process.
DATA SAFETY AND MONITORING BOARD (DSMB): An independent
committee, composed of community representatives and
clinical research experts, that reviews data while a
clinical trial is in progress to ensure that participants
are not exposed to undue risk. A DSMB may recommend that a
trial be stopped if there are safety concerns or if the
trial objectives have been achieved.
DOSE-RANGING STUDY: A clinical trial in which two or more
doses of an agent (such as a drug) are tested against each
other to determine which dose works best and is least
harmful.
DOUBLE-BLIND STUDY: A clinical trial design in which
neither the participating individuals nor the study staff
knows which participants are receiving the experimental drug
and which are receiving a placebo (or another therapy).
Double-blind trials are thought to produce objective
results, since the expectations of the doctor and the
participant about the experimental drug do not affect the
outcome; also called double-masked study.
DRUG-DRUG INTERACTION: A modification of the effect of a
drug when administered with another drug. The effect may be
an increase or a decrease in the action of either substance,
or it may be an adverse effect that is not normally
associated with either drug.
EFFICACY: (Of a drug or treatment). The maximum ability
of a drug or treatment to produce a result regardless of
dosage. A drug passes efficacy trials if it is effective at
the dose tested and against the illness for which it is
prescribed. In the procedure mandated by the FDA, Phase II
clinical trials gauge efficacy, and Phase III trials confirm
it .
ENDPOINT: Overall outcome that the protocol is designed
to evaluate. Common endpoints are severe toxicity, disease
progression, or death.
ENROLLING: The act of signing up participants into a
study. Generally this process involves evaluating a
participant with respect to the eligibility criteria of the
study and going through the informed consent process.
EXPERIMENTAL DRUG: A drug that is not FDA licensed for
use in humans, or as a treatment for a particular condition
FROM 1572: Form submitted by Principal Investigator which
contains contact details, CV, financial disclosure, conflict
of interest and agreement to conduct the study with ICH GCP
guidelines
INCLUSION/EXCLUSION CRITERIA: The medical or social
standards determining whether a person may or may not be
allowed to enter a clinical trial. These criteria are based
on such factors as age, gender, the type and stage of a
disease, previous treatment history, and other medical
conditions. It is important to note that inclusion and
exclusion criteria are not used to reject people personally,
but rather to identify appropriate participants and keep
them safe.
INSTITUTIONAL REVIEW BOARD (IRB): 1. A committee of
physicians, statisticians, researchers, community advocates,
and others that ensures that a clinical trial is ethical and
that the rights of study participants are protected. All
clinical trials in the U.S. must be approved by an IRB
before they begin. 2. Every institution that conducts or
supports biomedical or behavioral research involving human
participants must, by federal regulation, have an IRB that
initially approves and periodically reviews the research in
order to protect the rights of human participants.
INTENT TO TREAT: Analysis of clinical trial results that
includes all data from participants in the groups to which
they were randomized even if they never received the
treatment.
INVESTIGATIONAL NEW DRUG: A new drug, antibiotic drug, or
biological drug that is used in a clinical investigation. It
also includes a biological product used in vitro for
diagnostic purposes.
NEW DRUG APPLICATION (NDA): An application submitted by
the manufacturer of a drug to the FDA - after clinical
trials have been completed - for a license to market the
drug for a specified indication.
OFF-LABEL USE: A drug prescribed for conditions other
than those approved by the FDA.
ORPHAN DRUGS: An FDA category that refers to medications
used to treat diseases and conditions that occur rarely.
There is little financial incentive for the pharmaceutical
industry to develop medications for these diseases or
conditions. Orphan drug status, however, gives a
manufacturer specific financial incentives to develop and
provide such medications.
PEER REVIEW: Review of a clinical trial by experts chosen
by the study sponsor. These experts review the trials for
scientific merit, participant safety, and ethical
considerations.
PHARMACOKINETICS: The processes (in a living organism) of
absorption, distribution, metabolism, and excretion of a
drug or vaccine.
PHASE I TRIALS: Initial studies to determine the
metabolism and pharmacologic actions of drugs in humans, the
side effects associated with increasing doses, and to gain
early evidence of effectiveness; may include healthy
participants and/or patients.
PHASE II TRIALS: Controlled clinical studies conducted to
evaluate the effectiveness of the drug for a particular
indication or indications in patients with the disease or
condition under study and to determine the common short-term
side effects and risks.
PHASE III TRIALS: Expanded controlled and uncontrolled
trials after preliminary evidence suggesting effectiveness
of the drug has been obtained, and are intended to gather
additional information to evaluate the overall benefit-risk
relationship of the drug and provide and adequate basis for
physician labeling.
PHASE IV TRIALS: Post-marketing studies to delineate
additional information including the drug's risks, benefits,
and optimal use.
PRECLINICAL: Refers to the testing of experimental drugs
in the test tube or in animals - the testing that occurs
before trials in humans may be carried out.
PROTOCOL: A study plan on which all clinical trials are
based. 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.
QUERY: Any clarification sought from the clinical
monitor, data associates or sponsor
RECRUITING: The period, during which a trial is attempting
to identify and enroll participants for the study.
Recruitment activities can include advertising and other
ways of solicting interest from possible participants.
RISK-BENEFIT RATIO: The risk to individual participants
versus the potential benefits. The risk/benefit ratio may
differ depending on the condition being treated. .
STUDY CORDINATOR: They are employed by Principal
investigators. Study coordinators work directly with study
volunteers, providing them safety and protection while
collecting and managing the study data. They promote,
advertise, and conduct telephone and face-to-face screenings
to recruit volunteers. During the study process, they assess
volunteer condition and coordinate ongoing
clinical/laboratory testing and physical exams.
STUDY ENDPOINT: A primary or secondary outcome used to judge
the effectiveness of a treatment.
STUDY TYPE: The primary investigative techniques used in
an observational protocol; types are Purpose, Duration,
Selection, and Timing.
TOXICITY: An adverse effect produced by a drug that is
detrimental to the participant's health. The level of
toxicity associated with a drug will vary depending on the
condition which the drug is used to treat.
TREATMENT IND: IND stands for Investigational New Drug
application, which is part of the process to get approval
from the FDA for marketing a new prescription drug in the
U.S. It makes promising new drugs available to desperately
ill participants as early in the drug development process as
possible. Treatment INDs are made available to participants
before general marketing begins, typically during Phase III
studies. To be considered for a treatment IND a participant
cannot be eligible to be in the definitive clinical trial. |
