Clinical Research: Introduction and Ethics

Presented by- Submitted To-Bhavya Rewari Mrs. Jyothi Y.M.Pharm, 1st year Asst. Prof. Dept. of Pharmacology Dept. of Pharmacology

Krupanidhi College of Pharmacy

Bangalore

Contents

• Definition and Scope of clinical research• Role of sponsor• Study director or principal investigator• Clinical Research Associate in conduct of

Clinical Research

Clinical Research

• Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment regimens intended for human use

• These may be used for prevention, treatment, diagnosis or for relieving symptoms of a disease

Clinical Research

• According to the International Conference on Harmonization (ICH), the definition of a clinical trial or study is as follows:

Any investigation in human subjects intended to discover or verify the clinical, pharmacological and/or other pharmacodynamic effects of an investigational product, and/or to identify any adverse reactions to an investigational product, and/or to study absorption, distribution, metabolism, and excretion of an investigational product with the object of ascertaining its safety and/or efficacy.

Clinical Research

• The National Institutes of Health defines “clinical research” as research conducted with human subjects for which an investigator (or colleague) directly interacts with human subjects

• Excluded from this definition are in vitro studies that utilize human tissues that cannot be linked to a living individual

• Clinical research includes:

Patient-oriented research – This type of research involves a particular person or group of people, or uses materials from humans.

Clinical Research

This research can include-

1) mechanisms of human disease

2) therapeutic interventions

3) clinical trials

4) development of new technologies • Epidemiological and behavioral studies – These types

of studies examine the distribution of disease, the factors that affect health, and how people make health-related decisions

Clinical Research

• Outcomes and health services research – These studies seek to identify the most effective and most efficient interventions, treatments, and services

Role of a sponsor

• Sponsor is an individual, company, institution, or organization which takes responsibility for the initiation, management, and/or financing of a clinical trial

• This is the organization or individual that initiates the clinical trial and finances the study

• The organization may be a government department, pharmaceutical company, university, or individual

Role of a sponsor

• Sponsor team contain following-

Project Manager

CRA/Monitor

CRO (Contract Research Organization)

Data Manager

Biostatician

Medical Writer

Role of a sponsor

• Responsibilities of sponsor:

Selection of Site and Investigator

Sponsor responsibility is to select well qualified, trained and experienced investigator(s) for the conduct of trial.

The selected investigator should be based at the institutions/hospitals having sufficient resources to properly conduct the trial

Role of a sponsor

Allocation of Duties and Responsibilities

Prior to initiating a Study the Sponsor should define and allocate all Study related duties and responsibilities to the respective identified person(s)/organization(s)

Study director or principal investigator

• The Investigator is the person who conducts the trial• If there is a team in the investigation, then there is a

Principal Investigator• This person is normally an expert in the field of the

disease to be investigated• The Investigator ’ s responsibility is to ensure that GCP is

being implemented during the course of the trial and the subjects ’ rights and welfare are respected

• Another important point is that the Investigator has to maintain impartiality

• He/she is not an employee of the company (the Sponsor where the drug is developed), to show that there is transparency and no conflict of interest, nor is there financial gain if the drug is successful

References

• DRUGS-From Discovery to Approval, Second Edition, by RICK NG

• http://keck.usc.edu/Research/Clinical_Research/Definition.aspx

• http://en.wikipedia.org/wiki/Clinical_research• http://

www.slideshare.net/santoshzarkariya/sponsor-responsibilities-ppt