INTRODUCTION TO CLINICAL RESEARCH

What is Clinical research?

Clinical research composed of Medical and Behavioral research involving investigatory volunteer participants. The investigations of drugs that are carefully developed and conducted with recorded clinical outcomes. It includes identification of better ways to prevent, diagnose, treat, and understand human disease, trials that test new treatments clinical management and clinical outcomes, and long term studies, strict scientific guidelines & Ethical principles to protect participants.

Research process is a systematic investigational to 

establish fact treatment whereas the treatment is the 

care provided to improve a situation.

Clinical trial

Trial is nothing but following most promising treatments

in laboratories and animal studies. It is also referred as

clinical study.

A clinical trial includes

·        The Research study that tests how well an intervention works in a group of people.

·        Test for new methods of screening, prevention, diagnosis, or therapy etc.

·        At the time of clinical trial additional information is learned about an intervention, its risks, and its effectiveness and/or efficacy.

Clinical trials and their individual phases are a very important part of clinical research. They assure the safety and effectiveness of new drugs or treatments to be properly assessed before being approved for use in the general public.

Clinical Trial Classifications: 

Phases of Clinical Trials

•         Phase I:  Studies in normal healthy volunteers to understand safety and pharmacokinetics

•         Phase II: Drug dose ranging efficacy safety studies to determine the optimal dose for a particular indication.

•         Phase III: Large scale metacentric comparative studies to assess       efficacy safety of the study drug v/s currently accepted treatment

•         Phase IV: Post Marketing Studies

Experimental Studies:

Randomized Clinical Trials (RCT)

•         Compare outcomes (etiology, cause, efficacy of trial group and control group following an      intervention

most powerful tool to assess efficacy.

•         The Controlled, randomized, double-blind trials are the “Gold Standard” in clinical research

Randomized Clinical Trials (RCTs)

•         Placebo Control

It Compares one or more active treatments to a dosage form not containing an active treatment

•         Active Treatment 

Compares two or more treatments each with different ingredients

•         Historical Control

Compares observations in a current study with a previously conducted, similar study

What is ICH - GCP?

·        The aim of GCP is to protect the rights and safety of subjects and ensure data collected are accurate and valid.

·        Most governments are in the process of transforming GCP guidelines into regulations.

International ethical and scientific quality standard for:

•         Designing

•         Conducting

•         Recording

•         Reporting

Key Players in Clinical Trial

Career Prospects in India for Clinical Research

Pharmaceutical industry is a booming career for

researchers worldwide and in INDIA there are huge

openings for CR professionals due to increasing 

population.

Clinical Research Training Institute is demanding

 tremendous growth and job opportunities.

With the increasing flow of multinational sponsor’s Indian clinical research, there is exponential growth and new avenues for employment.

List of some of the avenues:

·        CRO (Contract research organization)

·        Pharma Industry

·        Biotech companies

·        Medical device companies

·        Patient recruitment organizations

·        Pharmacovigilance

·        Clinical trial operations

·        Clinical Data Management

·        Quality Assurance

·        Regulatory affairs

·        Research labs

·        Logistic services

·        Clinical trial audits

Every clinical research process requires a principal investigator to lead the study. These investigators could be medical practitioner’s professors, scientists, researchers.

Besides them, clinical trial studies need a visit array of professional is with various roles.

·        List of some of the roles:

·        Clinical Research Associate

·        Clinical Research Coordinator

·        Clinical research Manager

·        Clinical Data Manager

·        Clinical Data Coordinator

·        Quality control associate

·        Medical Coder

·        Medical Writer

·        Data entry associate

·        Bio technician

·        SAS Programmer

·        Quality assurance associate

·        Medical monitor

·        Pharmacovigilance associate

·        Lab staff

·        Research Nurse

·        Regulatory affair associate

·        Research auditor