CLINICAL RESEARCH

-SAI KRISHNA

STAGES OF DRUG DEVELOPEMENT

Discovery Product Characterization Formulation, Delivery, Packaging Development Pharmacokinetics And Drug Disposition Pharmacokinetic

 Preclinical Toxicology Testing - Acute Studies - Repeated Dose Studies - Genetic Toxicity Studies - Reproductive Toxicity Studies - Carcinogenicity Studies - Toxicokinetic Studies

 Bioanalytical Testing Clinical Trials

 Clinical research is a branch of medical 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.

 The term clinical research refers to the entire biography of a drug from its inception in the lab to its introduction to the consumer market and beyond. Once the promising candidate or the molecule is identified in the lab, it is subjected to preclinical studies or animal studies where different aspects of the drug (including its efficacy and toxicity) are studied.

 In the United States, the data obtained from the pre-clinical studies are submitted as an Investigational New Drug (IND) to the Food and Drug Administration (FDA) for permission to conduct human studies.

 In the European Union, the European Medicines Agency (EMEA) acts in a similar fashion for studies conducted in their region. These human studies are conducted in four phases in research subjects that give consent to participate in the clinical trials

 The Code of Federal Regulations (CFR) defines a clinical trial as the clinical investigation of a drug that is administered or dispensed to, or used involving one or more human subjects

Three Important Key Words

Experimental unit Treatment Evaluation of the treatment

Experimental unit
Referred as a subject from a target population under study Usually used to specify the intended study population to which the results of the study are inferenced

Treatment
A treatment can be a Placebo Combination of a new pharmaceutical identity New diet Surgical procedure Diagnostic test Medical device Health education proogram No treatment

Evaluation
Effectiveness and safety of treatment Pharmacoeconomics

CLINICAL TRIALS
Clinical trials are generally considered to be biomedical or health-related research studies in human beings that follow a predefined protocol. 2 TYPES I) Interventional II) Observational types

I)Interventional studies are those in which the research subjects are assigned by the investigator to a treatment or other intervention, and their outcomes are measured. II)Observational studies are those in which individuals are observed and their outcomes are measured by the investigators.

STEPS INVOLVED IN CLINICAL RESEARCH EFFORT

BENEFITS OF PARTICIPATION
Possible benefits: Patients will receive, at a minimum, the best standard treatment (if one exists) If the new treatment or intervention is proven to work, patients may be among the first to benefit Patients have a chance to help others and improve patient care

RISK OF PARTICIPATION
Possible risks: New treatments or interventions under study are not always better than, or even as good as, standard care Even if a new treatment has benefits, it may not work for every patient Health insurance and managed care providers do not always cover clinical trials

PATIENT PROTECTION
There have, unfortunately, been past abuses in patient protection Federal regulations ensure that people are told about the benefits, risks, and purpose of research before they agree to participate

HOW ARE PATIENTS RIGHTS PROTECTED Informed consent Scientific review Institutional review boards (IRBs) Data safety and monitoring boards (DSMBs)

INFORMED CONSENT
Purpose Procedures Potential risks and benefits Individual rights

SCIENTIFIC REVIEW
Institutional review boards (IRBs) are required by federal law for trials that are: --Federally funded --Subject to FDA regulation

DATA AND SAFETY MOBITORING BOARDS Ensure that risks are minimized Ensure data integrity Stop a trial if safety concerns arise or objectives have been met

Sometimes patients: Dont know about clinical trials Dont have access to clinical trials May be afraid or suspicious of research Cant afford to participate May not want to go against health care providers wishes

REASONS FOR FEW PEOPLE PARTICIPATING IN CLINICAL TRIALS

Health care providers might: Lack awareness of appropriate clinical trials Be unwilling to lose control of a persons care Believe that standard therapy is best Be concerned that clinical trials add administrative burdens