See discussions, stats, and author profiles for this publication at: https://www.researchgate.

net/publication/349534334

Clinical Trials: A General Review

Article · January 2016

DOI: 10.15520/ijcrr/2016/7/12/215

CITATION READS

1 5,710

3 authors, including:

Akhilesh Tiwari Megha Joshi

Indira Gandhi National Tribal University Institute of pharmacy, Vikram University
28 PUBLICATIONS   77 CITATIONS    13 PUBLICATIONS   32 CITATIONS   

SEE PROFILE SEE PROFILE

Some of the authors of this publication are also working on these related projects:

Synthesis, Characterization and Anti-Inflammatory Activity of Novel 1, 5-Disubstituted Indole Derivatives View project

All content following this page was uploaded by Akhilesh Tiwari on 23 February 2021.

The user has requested enhancement of the downloaded file.

International Journal of Contemporary Research and Review ISSN: 0976-4852
CrossRef DOI: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.

Clinical Trials: A General Review

Dr. AkhileshTiwari*, Megha Joshi, Dr. KamleshDashora

Institute of Pharmacy, Vikram University, Ujjain
E-mail- [email protected]
Accepted 2016-11-11; Published 2016-012-05

Abstract:

Clinical research is an important part of the drug discovery process to ensure the safety and efficacy of any
new drug. In today’s global scientific era, clinical trials are the compulsory for bringing newer and better
drugs to market. Clinical trials test potential treatments in human volunteers (subjects) to see whether they
should be approved for wider use in the general population. India stood as a global hub for clinical trials in
past years due to various factors.In this paper we discuss about clinical trials and clinical trials in India.

Key words: Clinical Trial, phases, Blind trial, Randomized trial

Introduction:

one or more health-related interventions to

Clinical trials as the name suggests are set of
evaluate the effects on health outcomes’.
experiments and observations done for clinical
research. in human subjects. They are carried out The main aspect of research in drug discovery
in search of new treatments, interventions or tests leads to newer, safer and more efficacious drugs
as a means to prevent, detect, treat or manage being made available for mankind. Before a new
various diseases or medical conditions. Clinical drug is introduced in the market, it has to go
Trials helps in determining if a new intervention through various phases of rigorous methods of
works, its safety & efficay, and is it better than trials first in animals and then in humans subjects.
already available treatments. According to WHO they are most important and decisive part for new
defines clinical trial as: drug to come in market. Without clinical trials,
researchers cannot properly determine whether
‘Any research study that prospectively assigns
new medicines developed in the laboratory or by
human participants or groups of humans to
using animal models are effective or safe, or
22131
International Journal of Contemporary Research and Review, Vol. 7, Issue. 12, Page no: 22131-22135
doi: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.
Dr. AkhileshTiwari et al, Clinical Trials: A General Review

whether a diagnostic test works properly in a • Diagnostic trials are conducted to find
clinical setting1-3. better tests or procedures for diagnosing a
particular disease or condition.
Types of clinical trial
• Treatment trials test experimental
treatments, new combinations of drugs, or
Clinical trials can be classified in to various ways
new approaches to surgery or radiation
One way is to classify clinical trials on basis of therapy.
mode of study • Quality of life trials (supportive care
trials) explore ways to improve comfort
1) Intervantional Study:-in this study
and the quality of life for individuals with
researchers measure how the subjects'
a chronic illness.
health changes. They give the research • Compassionate use trials or expanded
subjects a particular medicine and then access trials provide partially tested,
compare the treated subjects with those unapproved therapeutics to a small number
receiving no treatment or the standard
of patients who have no other realistic
treatment. This is a type of a comparative options. This involves a disease for which
study. no effective therapy has been approved, or
2) Clinical observational study:- in this a patient who has already failed all
study the researchers observe the subjects
standard treatments and whose health is
given with new medicine and measure too compromised to qualify for
their outcomes. participation in randomized clinical trials

Another way is to classify trials is by their

Phases of clinical trial
purpose
Phase I studies: this phase assess the safety of a
• Prevention trials to prevent disease in
drug or device. This is initial phase of testing,
people who have never had the disease or
which may take about several months to complete.
to prevent a disease from returning. These This phase usually includes a small number of
approaches may include medicines, healthy volunteers (20 to 100). The purpose of
vitamins, vaccines, minerals, or lifestyle
phase 1 trial is to determine the effect/ effects of
changes.
the drug or device on humans including how it is
• Screening trials test the best way to detect absorbed, metabolized, and excreted (ADME).
certain diseases or health conditions. This phase also investigates the dose related side

22132
International Journal of Contemporary Research and Review, Vol. 7, Issue. 12, Page no: 22131-22135
doi: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.
Dr. AkhileshTiwari et al, Clinical Trials: A General Review

effects. About 70% of experimental drugs pass Phase IV studies this phase is also called as Post
this phase of testing. Marketing Surveillance Trials. They are
conducted after a drug or device has been
Phase II studies: this phase assesses the efficacy
approved for consumer sale after approval from
of a drug or device. This is second phase of
regulatory authority. Pharmaceutical companies
testing. It takes several months to two years for
have several objectives at this stage: (1) to
completion, and involves up to several hundred
compare a drug with other drugs already in the
patients. Most phase II studies are randomized
market; (2) to monitor a drug's long-term
trials where one group of patients receives the
effectiveness and impact on a patient's quality of
experimental drug, while a second "control" group
life; and (3) to determine the cost-effectiveness of
receives a standard treatment or placebo. Often
a drug therapy relative to other available and new
these studies are "blinded" which means that
therapies. Phase IV studies can result in a drug or
neither the patients nor the researchers know who
device being taken off the market or restrictions of
has received the experimental drug. This allows
use could be placed on the product depending on
researchers to provide the pharmaceutical
the findings in the study4-6.
company and the FDA with comparative
information about the relative safety and Trial Design
effectiveness of the new drug. About one-third of
Adaptive clinical trial: - purpose of an adaptive
experimental drugs successfully complete both
trial is quickly identifying drugs that have a
Phase I and Phase II studies.
therapeutic effect done by adjusting dosing levels.
Phase III studies this phase assess randomized This trial evaluates a medical device or treatment
and blind trials in several hundred to several by observing participant outcomes on a prescribed
thousand patients. This is large-scale testing, schedule, and modifying parameters of the trial
which lasts up to several years. It provides the protocol in accord with those observations.
researchers and regulatory authority with a more Modifications parameters include dosage, drug
thorough understanding of the effectiveness of the undergoing trial, patient selection criteria, sample
drug or device, the benefits and the range of size and mix.
possible adverse reactions. About 70% to 90% of
Randomized trial: - Purpose of Randomized trial
drugs that enter Phase III trial successfully
is to reduce bias for testing new drug treatment. In
complete this phase of testing. Once Phase III is
this trial, each study subject is randomly assigned
complete, a pharmaceutical company can request
to receive either the study treatment or a placebo.
FDA approval for marketing the drug.
Group receiving placebo is control group.

22133
International Journal of Contemporary Research and Review, Vol. 7, Issue. 12, Page no: 22131-22135
doi: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.
Dr. AkhileshTiwari et al, Clinical Trials: A General Review

Randomized trial are used to check effectiveness pharmaceutical related issues in India. The DCGI
and efficacy of drug. is equivalent to the commissioner of FDA. India
follows schedule Y for drug trials and Schedule Y
Blind trial: - In blind trials, the subjects
is equivalent to the IND regulations 21CFR:312.
involved in the study do not know which study
In India, DCGI is not subdivided into several
treatment they receive and for what purpose. In
centers and offices to individually regulate
double blind trials, subjects and investigator /
different kinds of products. but, the DCGI himself
doctor do not know which medication is given.
signs on all applications filed with his office.
Neither the patients nor the researchers monitoring
These include not only clinical trial applications
the outcome know which patient is receiving
but all applications for marketing approval of
which treatment, until the study is over. It is very
drugs and medical devices, for import and export
effective to reduce bias.
of regulated products and for manufacturing. India
follows ICH E6 guidance for clinical trials7-9. The
Clinical trials in India
Indian Council of Medical Research (ICMR)
India is looked upon as a favorable destination for released an Indian version of GCPs to for India
conducting global clinical trials. It is estimated specific issues for conducting clinical operations.
that nearly 20% of all global clinical trials are An IEC in India is similar to an Institutional
conducted in India. Being the second largest Review Board (IRB) in the US. All sites need to
populated country in the world, India can have IEC approval, in addition to the DCGI’s
contribute significantly to global drug approval, before enrolling any subject. In India
development programs. India provides an clinical trial application process takes about 4-8
opportunity in terms of availability of large patient weeks for starting a trial, while in US, other
populations, highly educated talent, a wide European countries and Australia, it takes about 2-
spectrum of disease, lower costs of operations, 4 weeks for processing an application for trial.
low cost of medication compared to other
Conclusion
developed countries and a favorable economic,
intellectual property environment, and
A Clinical trial is compulsory for a drug/device to
importantly, use of English as the primary
ensure its safety & efficacy in humans before their
language make it easy to set up clinical sites in
usage. Clinical trials can provide answers
India. India’s equivalent to the US Food and Drug
regarding the use or not of a therapeutic agent that
Administration (FDA) and European Medicines
can benefit millions of patients worldwide.
Agency (EMEA) is the office of the Drugs
Although, the filing process of the clinical trial
Controller General (India) (DCGI). The DCGI is
application in India is a lengthy process; it
the federal official responsible for all
22134
International Journal of Contemporary Research and Review, Vol. 7, Issue. 12, Page no: 22131-22135
doi: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.
Dr. AkhileshTiwari et al, Clinical Trials: A General Review

involves many committees like NDAC, Technical Preferences & Growth Outlook" Syndicated
review committee, Apex Committee, Ethics Publication,
Committee but clinical trials in India have
7. "India: Prime Destination for Unethical Clinical
undergone many changes from 2008 to till date,
Trials". Common Dreams.
still altering. These changes made India to be a
global hub for clinical trials. Being the second
8. Paul J, Seib R, Prescott T (Mar 2005). "The
most populated country in the world, India can
Internet and Clinical Trials: Background, Online
contribute significantly to global drug
Resources, Examples and Issues" (Free full
development programs.
text). Journal of medical Internet research. 7 (1):
e5.
References

9. ICH Guideline for Good Clinical Practice:

1.http://www.temple.edu/pascope/about_trials.htm
Consolidated Guidance
2. Clinical trial Wikipedia, the free encyclopedia.
10. Pharmabiz.com, Mumbai (May 2014),ISCR
Available from: URL http://en.wikipedia.org/
releases Guide for clinical trial participants on
wiki/clinical_trial.
International Clinical Trials Day.
3. ICH Harmonized Tripartite Guideline for Good
11. Hannan, E. L. (2008). "Randomized clinical
Clinical Practice ‘Academy For Clinical
trials and observational studies: Guidelines for
Excellence’.
assessing respective strengths and
4. The Lancet (2009). "Phase 0 trials: A platform limitations". JACC: Cardiovascular
for drug development?". The Lancet. 374 (9685): Interventions.1 (3): 211–7
176–118
12. Rang, HP; Dale, MM; Ritter, JM; Moore, PK
5. Yang, Z. J., et al. (2010). "Motivation for (2003). Pharmacology 5 ed. Edinburgh: Churchill
Health Information Seeking and Processing About Livingstone.
Clinical Trial Enrollment." Health
Communication 25(5): 423-436.

6. Life Sciences Strategy Group, (May 2009)

"Clinical Trial Technology Utilization, Purchasing

22135
International Journal of Contemporary Research and Review, Vol. 7, Issue. 12, Page no: 22131-22135
doi: http://dx.doi.org/10.15520/ijcrr/2016/7/12/215.

View publication stats