Transcript Clinical Trials

Clinical Trial
Terminologies
Abbreviated protocol
• A summary protocol containing brief information about
the study which may be used as a concept document to
get internal approval to start the planning phase of a
study.
• It may also be used as an initial discussion document
for a meeting with a prospective Principal Investigator.
Action Letter
• The letter from regulatory authority to the sponsor
company,
in
response
to
an
application
submission to do a clinical study.
• It may be an “Approval letter” with some minor
modifications recommended or a “Non Approval
Letter” indicating that significant changes will be
needed before the application can be considered.
Admission criteria
• Basis for selecting target population for a
clinical trial.
• Subjects must be screened to ensure that their
characteristics match a list of admission
criteria and that none of their characteristics
match any single one of the exclusion criteria
set up for the study.
Adverse Drug Reaction (ADR)
• In case of approved pharmaceutical products: A noxious and
unintended response at doses normally used or tested in
human.
• In case of new unregistered pharmaceutical products ( or those
products which are not yet approved for the medical condition
where they are being tested): A noxious and unintended
response at any dose(s).
• In clinical studies, an untoward medical occurrence seemingly
caused by overdosing, abuse / dependence and interactions
with other medicinal products is also considered as an ADR.
Adverse Event/ Experience (AE)
• Any untoward medical occurrence (including a symptom/ disease or
an abnormal laboratory finding) during treatment with a
pharmaceutical product in a patient or a human volunteer that does
not necessarily have a relationship with the treatment being given.
•
When an Adverse Event has been assessed and there is reasonable
grounds for suspicion that it is causally related to the investigational
product(s) established, it must be considered as an Adverse Drug
Reaction.
Aim of Study
• The objective of the clinical study.
• Each study should only have one main objective.
• If additional objectives are required then a separate
study should be undertaken for each objective.
Amendment
• A document that describes changes or additions to an
Investigational New Drug (IND) filed with the
Regulatory Authority a supplement to a pending New
Drug Application (NDA) such as a safety or data update
or changes to a existing protocol.
Ascending Doses
Subjects are dosed with increasingly higher doses of a
drug until the maximum tolerated dose is reached. This
usually applies to a Phase- I study.
Archiving of Clinical Study Data
According to GCP Guidelines, clinical study data
should be stored for at least five years by the
investigator/ CRO and for the lifetime of the drug by
the pharmaceutical company.
Assent
• Agreement by an individual not competent to give legally
valid informed consent (e.g., a child or cognitively
impaired person) to participate in research.
Assurance
• A formal written, binding commitment that is submitted
to a Regulatory Agency in which an institution promises
to comply with applicable regulations governing research
with human subjects and stipulates the procedures
through which compliance will be achieved.
Audit of a Study
• A systematic verification of the study, carried out by persons
not directly involved, such as: Study related activities to
determine consistency with the Protocol.
• Studies data to ensure that there are no contradictions on
Source Documents.
•
The audit should also compare data on the Source Documents
with the interim or final report.
•
Compliance with the adopted SOPs.
Baseline
Measurements that are taken at the beginning of a study to serve as a
reference for subsequent measurements or observations.
Belmont Report
A statement of basic ethical principles governing research involving
human subjects issued by the U.S. National Commission for the
Protection of Human Subjects in 1978.
Bias
When a point of view prevents impartial judgment on issue relating
to the subject of that point of view. In clinical studies, this is
controlled by blinding and randomization.
Case History Record
The hospital chart or medical office file containing
medical and demographic information on the study
subject.
Causality
The relationship between the adverse experience and
the test agent in terms defined in the protocol.
Case Report/Record Form (CRF)
• A printed, optical, or electronic document designed to record all of
the protocol required information to be reported to the sponsor on
each trial subject. (ICH)
• A document designed in consonance with the Protocol, to record
data and other information on each study subject.
• The Case Record form should be in such a form and format that
allows accurate input, presentation, verification, audit and inspection
of the recorded data. A CRF may be in printed or electronic format.
Certificate of Destruction
• All returned and unused medication has to be destroyed at the end of
the study.
•
Normally this material is returned to the sponsor together with the
appropriate inventory.
• Certificate of destruction is issued which lists the drugs and the
quantity destroyed on a given date.
• This certificate is filed in the clinical study Master File.
Clean database (or file)
One from which errors have been eliminated and in which
measurements and other values are provided in the same units.
Clinical research associate (CRA)
Person employed by a sponsor, or by a contract research
organization acting on a sponsor’s behalf, who monitors the
progress of investigator sites participating in a clinical study. At
some (primarily academic) sites, clinical research coordinators
are called CRAs.
Clinical research coordinator (CRC)
• Person
who
handles
most
of
the
administrative
responsibilities of a clinical trial, acts as liaison between
investigative site and sponsor, and reviews all data and records
before a monitor’s visit.
Synonyms:
trial
coordinator,
nurse.
coordinator,
study
coordinator,
research
clinical coordinator, research nurse, protocol
Clinical trial
Systematic study of a test article (treatment, drug, device) In
one or more human subjects.
Synonyms: clinical study, clinical investigation.
Confidentiality
Prevention of disclosure, to other than authorized individuals,
of a sponsor’s proprietary information or of a subject’s identity.
(ICH)
Contract research organization (CRO)
A person or an organization (commercial, academic, or
other) contracted by the sponsor to perform one or more
of a sponsor’s trial-related duties and functions. (ICH)
Control group
The group of subjects in a controlled study that receives
no treatment, a standard treatment, or a placebo.
Controlled study
•
A study in which a test article is compared
with a treatment that has known effects.
• The control group may receive no treatment,
standard treatment, or placebo.
Database
Data stored in computer form for retrieval,
processing, and/or analysis.
Data monitoring
Process by which case report forms are
examined for completeness, consistency, and
accuracy.
Declaration of Helsinki
• A set of recommendations or basic principles that guide medical doctors
in the conduct of biomedical research involving human subjects.
•
It was originally adopted by the 18th World Medical Assembly (Helsinki,
Finland,1964);
Demographic data
•
Characteristics of subjects or study populations, which include such
information as age, sex, family history of the disease or condition for
which they are being treated, and other characteristics relevant to the study
in which they are participating.
Double-blind study
A study in which neither the subject(s) nor the
investigator(s) know what treatment a subject is receiving.
Ethics Committee
An independent review board or committee comprising of
medical,
scientific
and
non-medical/non-scientific
members, whose responsibility is to verify the protection of
the rights, safety and wellbeing of human subjects
involved in the study.
Food and Drug Administration (FDA)
The United States regulatory authority charged
with, among other responsibilities, granting
IND and NDA approvals.
Informed consent
A process by which a subject voluntarily
confirms his or her willingness to participate
in a particular trial, after having been
informed of all aspects of the trial that are
relevant to the subject’s decision to participate.
Impartial witness
A person, who is independent of the trial, who
cannot be unfairly influenced by people involved
with the trial, who attends the informed consent
process if the subject or the subject’s legally
acceptable representative cannot read, and who
reads the informed consent form and any other
written information supplied to the subject. (ICH)
Investigator
A person responsible for the conduct of the clinical trial at
a trial site. If a trial is conducted by a team of individuals at
a trial site, the investigator is the responsible leader of the
team and may be called the principal investigator. (ICH).
Monitor
Person employed by the sponsor or CRO who is
responsible for determining that a trial is being conducted in
accordance with the protocol.
Multicenter trial
A clinical trial conducted according to a single
protocol but at more than one site, and
therefore, carried out by more than one
investigator.
New Drug Application (NDA)
An application to FDA for a license to market
a new drug in the United States.
Nuremberg Code
• Code of ethics for conducting human medical
research set forth in 1947.
Open study
A trial in which subjects and investigators
know which product each subject is receiving;
opposite of double blind study.
Pharmacovigilance
Term used for adverse event monitoring and
reporting in some countries.
Prospective study
Investigation in which a group of subjects is
recruited and monitored in accordance with
criteria described in a protocol.
Randomization
The process of assigning trial subjects to
treatment or control groups using an element
of chance to determine the assignments in
order to reduce bias. (ICH)
Source documents
Original documents, data, and records
(e.g., hospital records, clinical and office charts, laboratory notes,
memoranda, subjects’ diaries or evaluation checklists, pharmacy
dispensing records, recorded data from automated instruments,
copies or transcriptions certified after verification as being accurate
copies, microfiches, photographic negatives, microfilm or magnetic
media, x-rays, subject files, and records kept at the pharmacy, at
the laboratories and at medico-technical departments involved
in the clinical trial). (ICH)
Sub investigator
Any individual member of the clinical trial
team designated and supervised by the
investigator at a trial site to perform critical
trial-related
procedures and/or to make
important trial related decisions
(e.g., associates, residents, research fellows).
(ICH)
Subject/trial subject
An individual who participates in a clinical trial, either as recipient
of the investigational product(s) or as a control. (ICH)
Subject identification code
A unique identifier assigned by the investigator to each trial subject
to protect the subject’s identity and used in place of subject’s name
when the investigator reports adverse events and/or other trialrelated data. (ICH)
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