intro clinical research2

50 %
50 %
Information about intro clinical research2

Published on October 19, 2008

Author: dr_paramesh


Molecules to Medicare:  Molecules to Medicare NUREMBERG CODE:  NUREMBERG CODE The voluntary consent of the human subject is absolutely essential. No element of force, fraud, deceit, duress, over-reaching or other ulterior form of constraint or coercion. Full disclosure of experiment. Investigator is personally responsible. The thalidomide tragedy, early 1960s:  The thalidomide tragedy, early 1960s The U.S. P.H.S. Syphilis Study:  The U.S. P.H.S. Syphilis Study THE BELMONT REPORT National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979:  THE BELMONT REPORT National Commission for the Protection of Human Subjects of Biomedical and Behavioral Research 1979 A. Boundaries between research and practice B. Ethical principles underlying the conduct of research: Respect for persons Beneficence Justice Declaration of Helsinki (2000):  Declaration of Helsinki (2000) The benefits, risks, burdens and effectiveness of a new method should be tested against those of the best current prophylactic, diagnostic, and therapeutic methods. This does not exclude the use of placebo, or no treatment, in studies where no proven prophylactic, diagnostic, and therapeutic method exists. Slide8:  Deaths Due to HIV Infection United States, 1980-2000 ~ 51,000 Deaths in Peak Year 1995 ~ 15,000 Deaths in 2000 80,000 60,000 40,000 20,000 0 1980 1985 1990 1995 2000 Year Annual Deaths ~ 77,000 Deaths Projected for 2000 62,000 Deaths Prevented in 2000 Slide9:  Coronary Heart Disease Age-Adjusted Death Rates: Actual and Expected United States, 1950-2000 500 400 300 200 100 0 1950 1955 1960 1965 1970 1975 1980 1985 1990 1995 2000 Deaths per 100,000 Year ~ 514,000 Actual Deaths in 2000 ~ 1,329,000 Projected Deaths in 2000 815,000 Deaths Prevented in 2000 OBJECTIVES OF PRECLINICAL TOXICOLOGY STUDIES :  OBJECTIVES OF PRECLINICAL TOXICOLOGY STUDIES DETERMINE IN APPROPRIATE ANIMAL MODELS: The Maximum Tolerated Dose (MTD) Dose Limiting Toxicities ( DLT ) Schedule-Dependent Toxicity Reversibility of Adverse Effects A Safe Clinical Starting Dose FDA PRECLINICAL PHARMACOLOGY & TOXICOLOGY REQUIREMENTS: ONCOLOGY Rx:  FDA PRECLINICAL PHARMACOLOGY & TOXICOLOGY REQUIREMENTS: ONCOLOGY Rx DRUGS Two Species - Rodent & Non-rodent Clinical Route & Schedule Follow NCI Guidelines Pharmacokinetics - Optional BIOLOGICALS Most Relevant Species Clinical Route & Schedule What is a clinical trial?:  What is a clinical trial? Planned study involving people The goal of a clinical trial is to find better ways to prevent or treat a disease in people. Phases of clinical trials:  Phases of clinical trials Phase I: Safety, dosing 15–30 people Phase II: Effectiveness Fewer than 100 people Phase III: Comparative effectiveness >100 to several thousand people Phase I: safety and dosing:  Phase I: safety and dosing Goal: to determine dosing (pharmacokinetics) and determine if medicine is safe in a small group of healthy volunteers Phase II study: safety and effectiveness:  Phase II study: safety and effectiveness If there are no serious safety problems in the Phase I, the medicine is tested in a Phase II study with more people. Phase III: safety and comparative effectiveness:  Phase III: safety and comparative effectiveness If Phase II results show medicine has no major safety problems and seems to be effective, researchers do a Phase III study. Phase III: most important effectiveness study:  Phase III: most important effectiveness study Goals Check safety. Check effectiveness. Find out how well medicine works compared to standard treatment. vs. Standard treatment Experimental treatment Phase IV study:  Phase IV study Goal: to determine long-term safety and effectiveness in large numbers of people Controlled study:  Controlled study Experimental Group Result Result Control Group VS. Study Sample Randomizing participants:  Randomizing participants Computer assigns participants to groups by a process called randomization. Study Sample *R Experimental Group Control Group *R=randomization of participant to a treatment group Randomizing participants:  Randomizing participants Study Sample R Experimental Group Control Group =Site X =Site Y Randomized, controlled studies:  Randomized, controlled studies Double-blind studies:  Double-blind studies Blinding: not letting the participant or the researcher know which group a participant is in Like randomization, blinding reduces the risk of bias. “Double-blind” means participants and researchers do not know if a participant is in experimental or control group. When data collection is complete, the researchers “unblind” the study. Placebo-controlled studies:  Placebo-controlled studies What if there is no medicine known to be an effective treatment? Researchers compare new medicine with a placebo The placebo and experimental treatment are made so that they look exactly the same vs. Experimental Group Placebo Control Group Placebo-controlled study:  Placebo-controlled study experimental control TRADITIONAL PHARMACEUTICAL R&D Suffers High Attrition*:  TRADITIONAL PHARMACEUTICAL R&D Suffers High Attrition* * Tufts CSDD, H&Q 1998; The Pfizer Journal, 1/2000 TRADITIONAL PHARMACEUTICAL R&D Costly* and Time Consuming**:  TRADITIONAL PHARMACEUTICAL R&D Costly* and Time Consuming** * Lehman Brothers, 1997; ** Tufts CSDD Lead Discovery Research 6 Years Drug Development 8.9 Years $608m* Sources of “Modern Drugs”:  Sources of “Modern Drugs” If one looks at the current drug scene from a chemical perspective (data from 1981 – 2002) then the following slides show reasonable approximations of the sources of drugs currently approved, World-wide, by the FDA or equivalent body. Codes are: N Natural Product ND Natural Product Derivative S* Natural Product Pharmacophore S Synthetic Compound B/V Biological / Vaccine (NM) Natural Product Mimic as a subdivision Discovery of Lidocaine:  Discovery of Lidocaine *Central Asian camels refused to eat a certain type of reed *Characterization of gramine as the antifeedant principle led to the synthesis of isogramine *Taste-test: numbness; therefore, lead for anesthetic agent development Courtesy of N. R. Farnsworth Slide30:  “For here we are not afraid to follow the truth wherever it may lead.”

Add a comment

Related presentations

Related pages

Intro to Clinical Research | Research + Innovation ...

Intro to Clinical Research. This three day course provides an introduction to the various resources relevant to those who will be developing and conducting ...
Read more

Intro | Upstate Clinical Research Associates

Upstate Clinical Research Associates,LLC Is A Dedicated, Multi-therapeutic Clinical Research Center. We Are Committed To Excellence In Conducting Phase II-IV
Read more

Intro to PubMed for Clinical Research Students - YouTube

Want to watch this again later? Sign in to add this video to a playlist. This very brief tutorial teaches how to access articles in full-text ...
Read more

Intro to Clinical Trials: FAQs | Clinical Trials of South ...

The idea of joining a clinical research study may be exciting, yet unfamiliar. Choosing to participate in a clinical research study is an important ...
Read more

Intro to clinical research

Page | 1 July 2013 Introduction to Clinical Research Office of Research and Faculty Development School of Dental Medicine Stony Brook ...
Read more

NIH Clinical Center: Introduction to the Principles and ...

The Introduction to the Principles and Practice of Clinical Research (IPPCR) is a course to train participants on how to effectively conduct clinical research.
Read more

Introduction to Clinical Research - NCURA Region I ...

Stage 3 . Informal Clinical Research Management. Process is informal, not well-defined, or based mainly on individual experience. Stage 0 . Functional Clinical
Read more

GCRC Intro to Clinical Research - University of Maryland ...

1 General Clinical Research Center Nancy Englar, MHL, BSN, RN Nurse Director L. Samuel Dongmo, Ph.D. Bioinformatics Core Director Kathleen Palmer, RN, CCRC
Read more

Clinical research - Wikipedia, the free encyclopedia

Clinical research is a branch of healthcare science that determines the safety and effectiveness of medications, devices, diagnostic products and treatment ...
Read more