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Organized research on human beings intended to provide adequate information on the drug use as a therapeutic agent on its safety and efficacy.
Only a well designed clinical study on a defined population can give meaningful results- (positive or negative) about any therapeutic intervention
cost of the drug development 900 million US $ time taken for the drug development 10-12 years of the cost and time is spent on clinical
Total
2/3rds
trials.
Historical review
19TH CENTURY
20th CENTURY
Ancient
pharmacy practice
Growth of Pharma industry 1947 Nuremberg code after the trials by the Nazi physicians Emphasized on the informed consent
Drugs given on trial and error basis Practicing physician decided all.
1950s Proper testing of drugs on human beings started The concept of randomized controlled clinical trials appeared.
Drugs and cosmetics act 1940 schedule-Y Indian GCP guidelines ICMR Guidelines WHO Guidelines ICH-GCP Guidelines
Clinical
Clinical research now Multidisciplinary, multinational, multibillion dollar global business governed by many complex and interrelated regulations and guidelines.
Sponsor Investigators Monitors Auditors and the quality control personnel. Biostatisticians.
Data management group. Regulatory Affairs. Reporting and Documentation medical writing. Business development group
Pharma companies Clinical/contract research organizations (CROs) Biotech companies Central diagnostic laboratories Clinical research training institutes
Clinical trials
Drug discovery
Drug development
PRECLINICAL STUDIES
Toxicity studies: Acute toxicity studies LD50 Sub- acute toxicity studies Chronic toxicity studies Special toxicity studies: carcinogenecity, teratogenicity 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
Phase-I - Clinical pharmacology, safety of new drugs Phase-II - Safety and efficacy of new drug in patients, exploratory trial.
Investigators
Subjects
International conference on harmonization(ICH) Good clinical practice(GCP) Independent ethics committee IEC Institutional Review board IRB Informed consent
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
MONITORIN G
Overseeing the progress of a clinical trial Ensuring that it is conducted according to the approved protocol, GCP, SOPs and the regulatory requirements.
Internal department of the CRO Avoids unnecessary risks to the patients. Essential to improve the quality of all the processes of the trial.
AUDI T
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
PHARMACOVIGILANC E
Collection of data on adverse effects of the drugs that are already in the market
PHARMACOEPIDEMIOLO GY
Collection of data in terms of both efficacy and safety after being prescribed to large number of patients.
OUTSOURCI NG
Transferring part of the activity of drug development to any other independent organizations (contractual research organizations).
FRAU D
Generation of a false data with an intention to deceive.
MISCONDUC T
Behavior which falls short of good ethical or scientific standards(carelessness)
BIOAVALABILITY STUDIES
Bioequivalence studies
Conducted for new formulations, Compare the new formulation of any established drug with the existing formulation.
Organized 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.
BIOSTATISTIC S
During the protocol designing To calculate number of patients to be included in the trial(sample size)
Randomization Review of data and For the final analysis of results by applying suitable statistical methods.
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. Preparation of research papers. Medico-marketing 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.
The End