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Introduction To Clinical Research: Drug Development

Clinical research involves organized studies on human subjects to evaluate the safety and efficacy of new drugs, medical devices, and other therapies. It is a highly regulated, multidisciplinary field that accounts for approximately two-thirds of the total time and costs associated with drug development. Clinical research has become more formalized over time with an increased focus on ethics, informed consent, and rigorous study design and documentation to ensure patient safety and reliable results.

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301 views

Introduction To Clinical Research: Drug Development

Clinical research involves organized studies on human subjects to evaluate the safety and efficacy of new drugs, medical devices, and other therapies. It is a highly regulated, multidisciplinary field that accounts for approximately two-thirds of the total time and costs associated with drug development. Clinical research has become more formalized over time with an increased focus on ethics, informed consent, and rigorous study design and documentation to ensure patient safety and reliable results.

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Introduction to clinical research

What is clinical research?


 Organized research on human beings
Intended to provide adequate information on the drug use as a therapeutic agent on its
safety and efficacy.
 Also referred to as Clinical trial management

Clinical research - position in drug development


Drug development
Discovery research
Formulation and development

Clinical development (trials)


Commercialization

When do we need clinical trials?


new drugs
for new uses of existing drugs,
medical devices,
new drug delivery systems etc.
Evidence to prove the efficacy and safety in human beings.
Only a well designed clinical study on a defined population can give meaningful
results- (positive or negative) about any therapeutic intervention

The need for organized study


EVALUATION OF DRUG X FOR OSTEOARTHRITIS
How many patients improved?
-approximately 150 /200
What was the percentage of improvement?
80-90%

CLINICAL TRIAL -I

Any drop outs?


-May be 10-12
Reasons?
-may be they did not get symptomatic relief???
Any side effects?
-Gastritis,headache,diarrhoea etc.
CLINICAL TRIAL - II
EVALUATION OF DRUG Y FOR OSTEOARTHRITIS
How many patients improved?
If the criteria of 40% is considered as improvement, 150/200 showed
improvement(p<.01)

What was the percentage of improvement?


100 patients 40-50%
40 patients 50-60%
10 patients 60-70%

Any drop outs?


There were 10 drop outs due to following reasons
3 -gastritis
4- no improvement
3 -reasons not known

Any side effects?


Gastritis,
headache,
diarrhoea etc.
tingling and numbness
1,2,3, were due to the drug.

OUTCOME
Clinical trial-1
Trial poorly designed
No definite outcome,
Results ambiguous

Clinical trial –2
Trial well designed, organised and conducted
Definite outcome.
Results- conclusive.

Scope of clinical research?


Total cost of the drug development
900 million US $

Total time taken for the drug development


10-12 years

2/3rds of the cost and time is spent on clinical trials.


Historical review-
19TH CENTURY

Ancient pharmacy practice


Drugs given on trial and error basis
Practicing physician decided all.

History: The concept of Ethics


20th CENTURY

Growth of Pharma industry


1947 Nuremberg code after the trials by the Nazi physicians
Emphasized on the informed consent

History: The concept of Ethics


1950s Proper testing of drugs on human beings started
The concept of randomised controlled clinical trials appeared.

Historical review: Ethics


Emphasized on the informed consent

WMA (world medical association)-1964-guidance to physicians and other participants in medical


research involving human subjects

Further growth in ethical issues


WMA (1964) (World Medical Association) guidance to physicians and other
participants in medical research involving human subjects
Declaration of Helsinki
Thalidomide disaster brought about an exponential growth in Pharmaceutical
legislation

Ethical issues today


International conference on hormonisation- Good clinical practices
(ICH-GCP) Guidelines
Institutional review board/Institutional ethics committee
Patients informed consent

Regulatory guidelines today


Drugs and cosmetics act 1940
schedule-Y
Indian GCP guidelines
ICMR Guidelines
WHO Guidelines
ICH-GCP Guidelines
Clinical research then and now
CLINICAL RESEARCH 50 YEARS AGO
- investigator driven informal activity

CLINICAL RESEARCH NOW


Multidisciplinary, multinational,multibillion dollar global business governed by many
complex and interrelated regulations and guidelines.

Clinical research -a multi-disciplinary approach


Sponsor
Investigators
Monitors
Auditors and the quality control personnel.
Biostatisticians.
Data management group.
Regulatory Affairs.
Reporting and Documentation medical writing.
Business development group

Players in Clinical Research Industry


Pharma companies
Clinical/contract research organisations(CROs)
Biotech companies
Central diagnostic laboratories
Clinical research training institutes

Understanding clinical research


New drug development
Drug discovery and development
Clinical trials

NEW DRUG DEVELOPMENT PROCESS


Drug discovery
Synthesis
Drug designing
Target validation(Preliminary in-vitro screening)
Pharmacological assays

Drug development
Safety
Efficacy
Kinetics
Formulation
PRECLINICAL STUDIES
Include studies conducted on Experimental animals for safety and efficacy

Toxicity studies
Acute toxicity studies LD50
Sub- acute toxicity studies
Chronic toxicity studies
Special toxicity studies-carcinogenecity,teratogenecity genotoxicity,effects on fertility
and reproduction

Efficacy studies
In- vitro assays-Studies conducted using only animal tissues or cells or enzyme
systems
In- vivo assays-Experiments using whole animals

CLINICAL TRIAL PHASES


Phase-I- Clinical pharmacology,safety of new drugs
Phase-II-safety and efficacy of new drug in patients,exploratory trial.
Phase-III-multicentric confirmatory trial.
Phase-IV-post- marketting surveillance

Who conducts the clinical trial?


Investigators
Principal investigator
Co-investigator

Who participates in the trial?


Subjects
Healthy Human Volunteers
Patients

Ethical issues and guidelines


International conference on harmonization(ICH)
Good clinical practice(GCP)
Independent ethics committee IEC
Institutional Review board IRB
Informed consent

Good clinical practice


It is the international standard for conducting the clinical trials which lays down the
standard for
Design
Conduct
Monitoring
Termination
Analysis and Documentation.

Informed consent
A written free consent of the subjects to participate in a clinical trial after receiving
complete information about the new product

Regulatory requirements
Drugs and cosmetics act 1940
Schedule-Y
DCGI Drug controller General of India
US-FDA United states-Food and drug administration act.
MHRA Medicinal and health care products regulatory agency

MONITORING
Overseeing the progress of a clinical trial
Ensuring that it is conducted according to the approved protocol, GCP, SOPs and the
regulatory requirements.
Usually done by Clinical research associates.

Quality control and quality assurance


Internal department of the CRO
Avoids unnecessary risks to the patients.
Essential to improve the quality of all the processes of the trial.

AUDIT
Systematic and independent examination of the trial related documents and activities
Checks whether the trial is going on as per the protocol,GCP,SOP.
Whether reported accurately or not

PHARMACOVIGILANCE
Collection of data on adverse effects of the drugs that are already in the market

PHARMACOEPIDEMIOLOGY
Collection of data in terms of both efficacy and safety after being prescribed to large number of
patients.

OUTSOURCING
Outside source utilisation for conducting a clinical study.
Transferring part of the activity of drug development to any other independent
organisations (contractual research organisations).

STANDARD OPERATING PROCEDURES


Written instructions to achieve uniformity in the performance.

FRAUD
Generation of a false data with an intention to deceive.

MISCONDUCT
Behaviour which falls short of good ethical or scientific standards(-carelessness)

BIOAVALABILITY STUDIES
To understand how much of drug is available for action.

Bioequivalence studies.
Conducted for new formulations,
Compare the new formulation of any established drug with the existing formulation.

Data management,analysis and validation


Organised collection of accurate data from the clinical trial,
Capture the data from the data base
To provide a clean data to the statistician to facilitate analysis.

BIOSTATISTICS
During the protocol designing
to calculate number of patients to be included in the trial(sample size)
randomisation
review of data and
For the final analysis of results by applying suitable statistical methods.

DOCUMENTATION AND REPORTING


Record any event or step in the data management
Necessary for retrospective analysis
for the purpose of audit

MEDICAL WRITING
To prepare reviews on the drug based on the available literature.
Preperation of research papers.
Medico-marketting literature.

SUMMARY
Clinical research is an integral part of drug development
Unlike the past, today the process has gained a unique position due to the regulatory
requirements and ethical guidelines available globally..
Designing, conducting,monitoring, appropriate quality assurance and data
management determine the success of the clinical research.

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