Volume 1, Issue 2, March – April 2010; Article 019 ISSN 0976 – 044X

CLINICAL TRIAL: A REVIEW

S. B. Thorat*, S. K. Banarjee, D. D. Gaikwad, S. L. Jadhav, R. M. Thorat

Vishal Institute of Pharmaceutical Education And Research, Ale, Pune-412411.
*E-mail : rupali.78@rediffmail.com

ABSTRACT
A clinical trial is a research study in human volunteers to answer specific health questions. Carefully conducted clinical trials are fastest
and safest way to find treatment that work in people and way to improve health. Investigational trials determine whether experimental
treatment or new ways of using known therapies are safe and effective under controlled environment. Observational trials address health
issues in large groups of people or population in natural settings. Clinical trials aim to measure therapeutic effectiveness and constitute
an important and highly specialized form of biological assay. In phase I pharmacokinetics, safety, gross effects are studied on human
volunteers, by clinical pharmacologists. If the drug passes the test, it enters phase II testings, where pharmacokinetics, safety, therapeutic
efficiency are studied on selected patients by clinical pharmacologist, if passes hundreds of selected patients are now studied, primarily
for safety and therapeutic effectiveness by clinical investigators in phase III. If this is passed the drug is now approved and marketed.
Even after marketing, physicians from various hospitals and clinics send their opinion about the drug, regarding ADR, efficacy in phase
IV.
Keywords: Clinical Trials, Preclinical Studies, Clinical studies, NDA.

INTRODUCTION Pre-clinical studies

A clinical trial is a research study that tests a new medical Pre-clinical studies involve in vitro (i.e., test tube or
treatment or a new way of using an existing treatment to laboratory) studies and trials on animal populations. Wide-
see if it will be a better way to prevent and screen for ranging dosages of the study drug are given to the animal
diagnose or treat a disease1. For any new drug to enter in subjects or to an in-vitro substrate in order to obtain
clinical trial, it must pass preclinical studies. Preclinical preliminary efficacy, toxicity and pharmacokinetic
studies involve in vitro (i.e. test-tube or Laboratory) information and to assist pharmaceutical companies in
studies and trials on animal populations. Wide range of deciding whether it is worthwhile to go ahead with further
dosages of the study drug is given to animal subjects or to testing.
an in-vitro substrate in order to obtain preliminary
Phase 0
efficacy, toxicity and pharmacokinetic information2.
Phase 0 is a recent designation for exploratory, first-in-
PHASES OF CLINICAL TRIAL
human trials conducted in accordance with the U.S. Food
and Drug Administration’s (FDA) 2006 Guidance on
Exploratory
Investigational New Drug (IND) Studies Phase 0 trials are
designed to speed up the development of promising drugs
or imaging agents by establishing very early on whether
the drug or agent behaves in human subjects as was
anticipated from preclinical studies. Distinctive features of
Phase 0 trials include the administration of single sub
therapeutic doses of the study drug to a small number of
subjects (10 to 15) to gather preliminary data on the
agent's pharmacokinetics (how the body processes the
drug) and pharmacodynamics (how the drug works in the
body).
Phase I
Phase I trials are the first stage of testing in human
subjects. Normally, a small (20-80) group of healthy
volunteers will be selected. This phase includes trials
designed to assess the safety (pharmacovigilance),
tolerability, pharmacokinetics, and pharmacodynamics of
a drug. These trials are often conducted in an inpatient
clinic, where the subject can be observed by full-time
Before pharmaceutical companies start clinical trials on a
staff. The subject who receives the drug is usually
drug, they conduct extensive pre-clinical studies3.
observed until several half-lives of the drug have passed.

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Phase I trials also normally include dose-ranging, also conditions. It is common practice that certain Phase III
called dose escalation, studies so that the appropriate dose trials will continue while the regulatory submission is
for therapeutic use can be found. The tested range of doses pending at the appropriate regulatory agency.
will usually be a fraction of the dose that causes harm in
While not required in all cases, it is typically expected that
animal testing. Phase I trials most often include healthy
there be at least two successful Phase III trials,
volunteers. However, there are some circumstances when
demonstrating a drug's safety and efficacy, in order to
real patients are used, such as patients who have end-stage
obtain approval from the appropriate regulatory agencies
disease and lack other treatment options. This exception to
(FDA (USA), TGA (Australia), EMEA (European Union),
the rule most often occurs in oncology (cancer) and HIV
etc.).
drug trials. Volunteers are paid an inconvenience fee for
their time spent in the volunteer centre. Pay ranges from a Once a drug has proved satisfactory after Phase III trials,
small amount of money for a short period of residence, to the trial results are usually combined into a large
a larger amount of up to approx £4000 depending on document containing a comprehensive description of the
length of participation. methods and results of human and animal studies,
manufacturing procedures, formulation details, and shelf
There are different kinds of Phase I trials:
life. This collection of information makes up the
1. SAD "regulatory submission" that is provided for review to the
appropriate regulatory authoritiesin different countries.
Single Ascending Dose studies are those in which small
groups of subjects are given a single dose of the drug Most drugs undergoing Phase III clinical trials can be
while they are observed and tested for a period of time. If marketed under FDA norms with proper recommendations
they do not exhibit any adverse side effects, and the and guidelines, but in case of any adverse effects being
pharmacokinetic data is roughly in line with predicted safe reported anywhere, the drugs need to be recalled
values, the dose is escalated, and a new group of subjects immediately from the market. While most pharmaceutical
is then given a higher dose. This is continued until pre- companies refrain from this practice, it is not abnormal to
calculated pharmacokinetic safety levels are reached, or see many drugs undergoing Phase III clinical trials in the
intolerable side effects start showing up at which point the market.
drug is said to have reached the Maximum tolerated dose
Phase IV
(MTD).
Phase IV trial is also known as Post Marketing
2. MAD
Surveillance Trial. Phase IV trials involve the safety
Multiple Ascending Dose studies are conducted to better surveillance (pharmacovigilance) and ongoing technical
understand the pharmacokinetics & pharmacodynamics of support of a drug after it receives permission to be sold.
multiple doses of the drug. Phase IV studies may be required by regulatory authorities
or may be undertaken by the sponsoring company for
Phase II
competitive (finding a new market for the drug) or other
Once the initial safety of the study drug has been reasons (for example, the drug may not have been tested
confirmed in Phase I trials, Phase II trials are performed for interactions with other drugs, or on certain population
on larger groups (20-300) and are designed to assess how groups such as pregnant women, who are unlikely to
well the drug works, as well as to continue Phase I safety subject themselves to trials). The safety surveillance is
assessments in a larger group of volunteers and patients. designed to detect any rare or long-term adverse effects
When the development process for a new drug fails, this over a much larger patient population and longer time
usually occurs during Phase II trials when the drug is period than was possible during the Phase I-III clinical
discovered not to work as planned, or to have toxic effects. trials. Harmful effects discovered by Phase IV trials may
result in a drug being no longer sold, or restricted to
Phase II studies are sometimes divided into Phase IIA and certain uses: recent examples involve cerivastatin (brand
Phase IIB. Phase IIA is specifically designed to assess names Baycol and Lipobay), troglitazone (Rezulin) and
dosing requirements (how much drug should be given), rofecoxib (Vioxx)2.
whereas Phase IIB is specifically designed to study
efficacy (how well the drug works at the prescribed INVESTIGATIONAL NEW DRUG (IND) /
dose(s)). Some trials combine Phase I and Phase II, and CLINICAL TRIAL EXCEPTION (CTX) / CLINICAL
test both efficacy and toxicity. TRIAL AUTHORIZATION (CTA) APPLICATION
Phase III INDs (in the U.S.), CTXs (in the U.K.) and CTAs (in
Australia) are examples of requests submitted to
Phase III studies are randomized controlled multicenter
appropriate regulatory authorities for permission to
trials on large patient groups (300–3,000 or more
conduct investigational research. This research can include
depending upon the disease/medical condition studied) testing of a new dosage form or new use of a drug already
and are aimed at being the definitive assessment of how approved to be marketed.
effective the drug is, in comparison with current 'gold
standard' treatment. Because of their size and In addition to obtaining permission from appropriate
comparatively long duration, Phase III trials are the most regulatory authorities, an Institutional or Independent
expensive, time-consuming and difficult trials to design Review Board (IRB) OR Ethical Advisory Board must
and run, especially in therapies for chronic medical approve the protocol for testing as well as the informed
consent documents that volunteers sign prior to

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Volume 1, Issue 2, March – April 2010; Article 019 ISSN 0976 – 044X

participating in a clinical study. An IRB is an independent members, whose responsibility it is to ensure the
committee of physicians, community advocates and others protection of the rights, safety and well-being of human
that ensures a clinical trial is ethical and the rights of study subjects involved in a trial and to provide public assurance
participants are protected. of that protection, by among other things, reviewing and
approving /providing favorable opinion on, the trial
NEW DRUG APPLICATION (NDA) / MARKETING
protocol, the suitability of the investigators facilities, and
AUTHORIZATION APPLICATION (MAA)
the methods and material to be used in obtaining and
NDAs (in the U.S.) and MAAs (in the U.K.) are examples documenting informed consent of the trial subjects.
of applications to market a new drug. Such application
The legal status, composition, function, operations and
document safety and efficacy of the investigational drug
regulatory requirements pertaining to Independent Ethics
and contain all the information collected during the drug
Committees may differ among countries, but should allow
development process. At the conclusion of successful
the independent Ethics Committee to act in agreement
preclinical and clinical testing, this series of documents is
with GCP as described in this guideline.
submitted to the FDA in the U.S. or to the applicable
regulatory authorities ion other countries. The application COMPLIANCE WITH PROTOCOL
must present substantial evidence that the drug will have
The investigator/institution should conduct the trial in
the effect it is represented to have when people use it or
compliance with the protocol agreed to by the sponsor
under the conditions for which it is prescribed
and, if required, by the regulatory authority (ies) and
recommended or suggested in the labeling. Obtaining
which were given approval/ favourable opinion by the
approval to market a new drug frequently takes between
IRB/IEC. The investigator/ institution and the sponsor
six months and two years4.
should sign the protocol, or an alternative contract, to
TYPES OF CINICAL TRIAL: confirm agreement.
1. Treatment trials The investigator should not implement in deviation from,
or changes of the protocol without agreement by the
Test experimental treatments, new combinations of drugs,
sponsor and prior review and documented approval /
or new approaches to surgery or radiation therapy.
favorable opinion from the IRB / IES of an amendment,
2. Prevention trials except where necessary to eliminate an immediate
hazard(s) to trial subject, or when the change(s) involves
Look for better ways to prevent disease in people who only logistical or administrative aspect of the trial (e.g.
have never had the disease or to prevent a disease from change in monitor (s), change of telephone no.(s).
returning. These approaches may include medicines,
vitamins, vaccines, minerals, or lifestyle changes. The investigator, or person designated by the investigator,
should document and explain any deviation from the
3. Diagnostic trials approved protocol.
Conducted to find better tests or procedures for diagnosing
The investigator may implement a deviation from, or a
a particular disease or condition.
change of the protocol to eliminate an immediate hazard(s)
4. Screening trials to trial subjects without prior IRB/IEC approval/ favorable
opinion. As soon as possible, the implemented deviation
Test the best way to detect certain diseases or health or change, the reasons for it, and if appropriate, the
conditions. proposed protocol amendment(s) should be submitted.
5. Quality of Life 1. To the IRB/IEC for review and approval/favorable
Trials (or Supportive Care trials) explore ways to improve opinion.
comfort and the quality of life for individuals with a 2. To the sponsor for agreement.
chronic illness2..
3. To the regulatory authority (IES).
MONITORING CLINICAL TRIALS:
PLANS OF CLINICAL TRIALS
The purposes of trial monitoring are to verify that:
Trials may be open, blind or double-blind.
1. The rights and well being of human subjects are
protected. 1. Open trial
2. The reported trial data are protected. In an open trial, the researcher knows the full details of the
treatment and so does the patient. These trials are open to
3. The conduct of the trial is in compliance with the challenge for bias, and they do nothing to reduce the
currently approved protocol/amendment(s), with placebo effect. However, sometimes they are unavoidable,
GCP, and with the applicable regulatory as placebo treatments are not always possible (see
requirement(s). Blinding). Usually this kind of study design is used in
ETHICAL CONSIDERATION bioequivalence studies.
An Independent body (a review board or a committee,
institutional, regional, national, or supranational),
constituted of medical professionals and non- medical

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1. Blind trials individuals who can serve as the legally authorized

representative.
A. Single-blind trial
In some U.S. locations, the local IRB must certify
In a single-blind trial, the researcher knows the details of
researchers and their staff before they can conduct clinical
the treatment but the patient does not. Because the patient
trials. They must understand the federal patient privacy
does not know which treatment is being administered (the
(HIPAA) law and good clinical practice. International
new treatment or another treatment) there might be no
Conference of Harmonization Guidelines for Good
placebo effect. In practice, since the researcher knows, it is
Clinical Practice (ICH GCP) is a set of standards used
possible for him to treat the patient differently or to
internationally for the conduct of clinical trials. The
subconsciously hint to the patient important treatment-
guidelines aim to ensure that the "rights, safety and well
related details, thus influencing the outcome of the study.
being of trial subjects are protected". The declaration of
B. Double-blind trial Helsinki of the World Medical Association (1964) codifies
recommendation for guidance of doctors in clinical
In a double-blind trial, one researcher allocates a series of research7.
numbers to 'new treatment' or 'old treatment'. The second
researcher is told the numbers, but not what they have ICH GCP GUIDELINES
been allocated to. Since the second researcher does not
The principals of ICH GCP --
know, he cannot possibly tell the patient, directly or
otherwise, and cannot give in to patient pressure to give 1. Clinical trial should be conducted in accordance with
him the new treatment. In this system, there is also often a the ethical principals that have their origin in the
more realistic distribution of sexes and ages of patients. Declaration of Helsinki, and that are consistent with
Therefore double-blind (or randomized) trials are GCP and the applicable regulatory requirement.
preferred, as they tend to give the most accurate results.
2. Before a trial is initiated, foreseeable risks and
C. Triple-blind trial inconveniences should be weighed against the
anticipated benefit for the individual trial subject and
Some randomized controlled trials are considered triple-
society. A trial should be initiated and continued only
blinded, although the meaning of this may vary according
if the anticipated benefits justify the risks.
to the exact study design. The most common meaning is
that the subject, researcher and person administering the 3. The rights, safety, and well being of the trial subjects
treatment (often a pharmacist) are blinded to what is being are the most important considerations and should
given. Alternately, it may mean that the patient, researcher prevail over interests of science and society.
and statistician are blinded. The team monitoring the
4. The available nonclinical and clinical information on
response may be unaware of the intervention being given
an investigational product should be adequate to
in the control and study groups. These additional
support the proposed clinical trial.
precautions are often in place with the more commonly
accepted term "double blind trials", and thus the term 5. Clinical trials should be scientifically sound, and
"triple-blinded" is infrequently used. However, it connotes described in a clear, detailed protocol.
an additional layer of security to prevent undue influence
6. A trial should be conducted in compliance with the
of study results by anyone directly involved with the
study6 protocol that has received prior institutional review
board (IRB) independent ethics committee (IEC)
ETHICAL CONDUCT approval / favorable opinion.
Clinical trials are closely supervised by appropriate 7. The medical care given to and medical decisions made
regulatory authorities. All studies that involve a medical or on behalf of, subjects should always be the
therapeutic intervention on patients must be approved by a responsibility of a qualified physician, or when
supervising ethics committee before permission is granted appropriate, of a qualified dentist.
to run the trial. The local ethics committee has discretion
8. Each individual involved in conducting a trial should
on how it will supervise nonintervention studies
(observational studies or those using already collected be qualified by education, training, and experience to
data). In the U.S., this body is called the Institutional perform his or her respective tasks.
Review Board (IRB). Most Ribs are located at the local 9. Freely given informed consent should be obtained
investigator's hospital or institution, but some sponsors from every subject prior to clinical trial participation.
allow the use of a central (independent/for profit) IRB for
investigators who work at smaller institutions. 10. All clinical trial information should be recorded,
handled, and stored in a way that allows its accurate
To be ethical, researchers must obtain the full and reporting, interpretation and verification.
informed consent of participating human subjects. (One of
the Rib’s main functions is ensuring that potential patients 11. The confidentiality of records that could identify
are adequately informed about the clinical trial.) If the subjects should be protected, respecting the privacy
patient is unable to consent for him/herself, researchers and confidentiality rules in accordance with the
can seek consent from the patient's legally authorized applicable regulatory requirement.
representative. In California, the state has prioritized the 12. Investigational products should be manufactured,
handled, and stored in accordance with applicable

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good manufacturing practice (GMP). They should be ROLE OF PLACEBO

used in accordance with the approval protocol.
Placebo is a Latin term which means “ I may please
13. Systems with procedures that assure the quality of you.” The placebo effect is an effect attributable to a
every aspect of the trial should be implanted5. medicament as a procedure, and is not due to any
specific pharmacodynamic property of the substance
INTERNATIONAL CONFERENCE ON
for the condition being treated. Placebo effect may be
HARMONIZATION GUIDELINES
defined as “ how the patients perception of treatment
In Recognition of the international market place for influences his / her response.” Placebos are used, During
pharmaceutical and in an effort to achieve global the clinical trial, to eliminate the possibility that the
efficiency for both regulatory agencies and the benefit of the drug is solely due to chance; and as
pharmaceutical industry, the FDA, counterpart agencies of therapeutic agents that work psychologically.
the European Union and Japan and geographic
A placebo preparation is usually an inert substance
representatives of the pharmaceutical industry formed a
like starch or lactose. However occasionally it may be
tripartite organization in 1991 to discuss, identify, and
a drug that is active but in a different situation. In
address relevant regulatory issues.
fact, even when an active drug is used, its placebo
This organization, named the international conference on effect often comforts the patient much before the
Harmonization of Pharmaceuticals for Human Use (ICH) drug is effective. It is well known that the patient as
has worked toward harmonizing, or bringing together, well as his relatives get some immediate relief as
regulatory requirements with the long-range goal of soon as the doctor’s medicine is administered,
establishing a uniform set of standards for drug irrespective of its drug content. This is because of
registration within these geographic areas. their faith in the doctor that things will go well in
his hands.
With ICH success, duplicative technical requirements for
registering Pharmaceuticals would be eliminated, new Placebos can often produce relief of subjective
drug approvals would occur more rapidly, patients’ access symptoms associated with psychological disturbances.
to new medicines would be enhanced worldwide, the This includes relief from anxiety, headache, pain,
quality, safety, and efficacy of imported products would insomnia and breathlessness. Hence placebos are often
be improved, and there would be an increase in employed in the treatment of certain diseases where
information transfer between participating countries. the psychic element is suspected to be responsible for
subjective symptoms. Objective responses such as
The ICH’s work toward uniform standards is focused on increase or decrease in Europhiles and eosinophils
three general areas, quality, safety and efficacy. The may sometimes be seen with placebos. When
quality topic includes stability, light stability, analytical administered for its therapeutic effects, the placebo
validation, impurities, and biotechnology. The safety
preparation, must appear to be relevant to the illness, must
topics include carcinogenicity, genotoxicity,
be harmless, Should preferably conform to the patient’s
toxicokinetics, reproduction toxicity and single and repeat-
expectations and To be effective, the ‘potency ‘ of the
dose toxicity.
preparation must be shown by some signs such as
The efficacy topics include population exposure, strong taste, a colorful capsule or a tablet of odd
managing clinical trials, clinical study reports, dose shape and sometimes even by obvious but harmless
response, ethic factors, good clinical practices, and side effect like colored urine.
geriatrics. For each topic, relevant regulations are During clinical trials, placebos are used to eliminate
identified, addressed and consensus guidelines developed. the effect of bias of the physician and the patient,
The intension is that these guidelines will be incorporated particularly in evaluating a new drug claimed to be
in to domestic regulations. In the United states the effective in conditions like bronchial asthma, angina
resulting guidelines are published in the Federal Register pectoris, pain and psychiatric disorders. In such cases
as notices, with accompanying statements indicating that the placebo should be indistinguishable from the
the guideline should be “Useful” or “considered” by active medicament in physical prosperities like color,
applicants conducting required studies or submitting smell, taste and form.
registration applications. Placebo effect may be modified by:
Examples of specific ICH developed guidelines: 1. Personality of the physician.
1. Stability testing of new drug substances and products 2. Personality of the patient.
2. Validation of analytical procedures for
3. Form of administration9
Pharmaceuticals
ROLE OF PHARMACISTS IN CLINICAL TRIALS
3. Impurities in new drug substances and products
Pharmacists have an active role to play in research and
4. General consideration for clinical trial8. clinical trials first of all, we provide the necessary
facilities required for proper storage of the investigational
medicinal products (IMPs), either in the fridge or at

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controlled room temperature. Regular temperature human volunteers for confirmation of useful properties of
monitoring is ensured and recorded. new drug. After preclinical development, investigational
new drug passes through clinical phases I, II, III and IV.
It is also the pharmacist’s duty to ensure there is constant
These phases provide in detail explanation of
supply of IMPs at all times, and that they are dispensed to
pharmacokinetic, pharmacodynamic profile and side effect
patients accordingly. Patients are counselled on the correct
which may be harmful or beneficial, adverse effect and
use of the IMPs in addition to any written information that
post marketing surveillance.,
is provided, such as, Informed Consent Form or the Patient
Information Leaflet. IMPs returns from patients are
REFERENCES
counted and documented to determine compliance to the
treatment. For inject able IMPs, pharmacists will also
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ensure that they are prepared in accordance to the
http://www.temple.edu/pascope/about_trials.html
specifications stipulated in the trial, and that they are
administered appropriately. 2. Clinical trial wikipedia, the free encyclopedia. Jan 28
2008. Available from: URL http://en.wikipedia.org/
Besides managing clinical trials, oncology pharmacists
wiki/clinical_trial. 28 Jan 2008.
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chemotherapy or other supportive drugs like anti-emetics, Pharmacology, 3rd ed, Vallabh Prakashan New Delhi,
blood growth factor injections, etc. 2004, 21.
Drug Utilization Evaluations (DUEs) are research projects 4. Itkar S., Pharmaceutical Management, 3rd ed, Nirali
that are commonly conducted by pharmacists. These Prakashan, Pune, 2007, 13.4-13.5.
projects aim to facilitate rational use of drugs within our
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patients. Essentially, providing insights on how drugs are
Clinical Practice ‘Academy For
used in patients and observing prescribing patterns by our
Clinical Excellenge’.
physicians. DUEs are sometimes considered as drug audits
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CONCLUSION 08/pharmacy.
A clinical trial for any new drug follows under the
guidelines of ICH and GCP, clinical trial are conducted in

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