clinical trials

Views:
 
Category: Entertainment
     
 

Presentation Description

Hi, In drug industry clinical trial is a very important phase in Drug Discovery & Development process... But many of us don't even know what that really means... Its a very essential thing to know... And I'm sure that this presentation will help you to enlarge the boundaries of your knowledge... Please give Like if u get any help from our work... Thank you

Comments

Presentation Transcript

Slide 1:

CLINICAL TRIALS PRESENTED BY: ROHAN SINGH SNEHASHIS SARKAr B . PHARM

CONTENTS :

CONTENTS INTRODUCTION GOOD CLINICAL PRACTICES ASSESSMENT OF SAFETY AND EFFICACY DESIRED CRITERIAS DESCRIPTION OF PHASES INVOLVED REGULATORY AUTHORITIES – IND & NDA APPLICATION IN PHARMACEUTICAL INDUSTRY ROLE OF PHARMACISTS IN CLINICAL TRIALS CONCLUSION REFERENCE

INTRODUCTION:

INTRODUCTION A systematic path of pharmaceutical products on human subjects . It discovers or verify the clinical, pharmacological adverse effects. Biomedical and interventions of NEW CHEMICAL ENTITY(NCE) can be known. Safety ,efficacy and effectiveness of the drug can be evaluated by monitoring their effects on large group of people.

INTRODUCTION:

INTRODUCTION The similarity in control groups is achieved by random assignment of patients or volunteers. Clinical trials is preferred to make health care decisions and evidence based medicine to support clinical and health policy choices or issues .

GOOD CLINICAL PRACTICES-PRINCIPLES:

GOOD CLINICAL PRACTICES-PRINCIPLES A standard for designing, conducting , recording and reporting of studies involving human subjects. Statistical designs of the protocols ,use of placebo is required. Cross-over study and the statistical analysis of clinical data should be generated.

GOOD CLINICAL PRACTICE - GUIDELINES:

GOOD CLINICAL PRACTICE - GUIDELINES Trials be conducted in accordance with the ethical principles defined in the declaration of Helsinki. A trial should be conducted and continued if the anticipated benefits justify the risks. Trials should be describes in a clear, detailed protocol. The decisions made in the protocol are the responsibility of a qualified physician or dentist(as appropriate)

GOOD CLINICAL PRACTICES:

GOOD CLINICAL PRACTICES

MEDICAL REASONS FOR DRUG DISCONTINUATION:

MEDICAL REASONS FOR DRUG DISCONTINUATION Lack of efficacy of drug. Intolerable adverse interactions. Subject’s condition deteriorates with time. Abnormal laboratory value. Didn’t meet the original entry criteria.

ASSESSMENTS OF SAFETY:

ASSESSMENTS OF SAFETY Specifications of safety parameters. Methods and periodicity for assuring and recording safety parameters. Procedures for eliciting reports of adverse drug interactions.

ASSESSMENTS OF EFFICACY:

ASSESSMENTS OF EFFICACY Specification of the effective parameters to be used. Descriptions of how effects are measured and recorded. Time and periodicity of effect recording.

CRITERIAS TO PERFORM:

CRITERIAS TO PERFORM Inclusion and Exclusion criteria are a very important aspects of clinical research. The inclusion and exclusion criteria are predominantly outlined in protocol to yield the best results for the research participants . It helps the researcher to take the precise decisions while including the subjects, thereby eventually impacting the analysis and interpretation of results in clinical research .

INCLUSION CRITERIA:

INCLUSION CRITERIA Inclusion criteria provide a set of principles which may be summoned up as - Inclusion of the patients widely depends on factors like: The purpose of the study Trial Design Methodology Subject demography-age, gender, occupation etc.

EXCLUSION CRITERIA:

EXCLUSION CRITERIA The process or the criteria that excludes certain group of people to be included in clinical trial process can be summoned up as - The literature on the basis of sex/gender, race, and ethnicity Sample Size Feasibility of study Research Purpose

DESCRIPTION OF PHASES INVOLVED:

DESCRIPTION OF PHASES INVOLVED

ELABORATING PHASES:

ELABORATING PHASES An investigational medicine is often evaluated in two or more phases

PHASE- 0/PRE CLINICAL PHASE:

PHASE- 0/PRE CLINICAL PHASE First-inhuman trials conducted in accordance with the U.S. Food and Drug Administration’s (FDA) Includes the administration of the study drug to a small number of subjects (10 to 15) to gather preliminary data on the agent's pharmacokinetics & pharmacodynamics .

PHASE- 1 (up to several months):

PHASE- 1 (up to several months ) Initial safety trials on a new API. An attempt to establish the dose range tolerated by volunteers for single and for multiple doses. Normally, a small (15- 100) group of healthy volunteers. Sometimes conducted on ill patients

PHASE- 2 (up to 2 years):

PHASE- 2 (up to 2 years ) Evaluating efficiency & safety. Starts when phase 1 is concluded. Performed on larger groups (20-300) Phase II studies are sometimes divided into Phase IIA and Phase IIB.

PHASE- 2A & B:

PHASE- 2A & B 2A- Objectives focus on dose-response, type of patient, frequency of dosing, or numerous other characteristics of safety and efficacy. 2B- Represents the most rigorous demonstration of a medicine's efficacy.

PHASE- 3 (one to four years):

PHASE- 3 (one to four years ) Most expensive, time consuming process, difficult trials to design and run Randomized controlled multicenter trials on large patient groups (300–3,000 or more) At least two successful Phase III trials needed in order to obtain approval from the appropriate regulatory agencies

PHASE- 4 (more than one year):

PHASE- 4 (more than one year ) Post Marketing Surveillance Trial Infinite process Surveillance and ongoing technical support of a drug after it receives permission to be sold. Different formulations medicine comparisons are evaluated.

REGULATORY AUTHORITIES- IND & NDA:

REGULATORY AUTHORITIES- IND & NDA The role of these authorities is to provide the legal framework for clinical trials. AN IMPORTANT DISTINCTION:- 1 . Role of Regulating Authorities 2. Role of Government

Role of Regulatory Authorities:

Role of Regulatory Authorities Ensuring the quality of the investigational product Ensuring subject rights and safety during a study Educating the parties who conduct or oversee the study Receiving and acting on complaints about a clinical study

Role of Government:

Role of Government Establish a legal framework for GCP Protect rights and safety of subjects Ensure quality of data, quality of regulatory decisions and implementation of quality systems Sanctions/ penalties for violators Licensure of medical professionals Qualifications of clinical investigators/ staff Provide mandates to the regulatory authority

Aim of regulatory body:

Aim of regulatory body To protect the safety and rights of the subjects participating in a trial (ii) To ensure that trials are adequately designed to meet scientifically sound objectives.

APPLICATION IN-PHARMACEUTICAL INDUSTRY:

APPLICATION IN-PHARMACEUTICAL INDUSTRY The pharmaceutical industry plays an active role in policy surrounding the research, discovery and development of new NCE.

Relation between clinical trial & pharmaceutical industry:

Relation between clinical trial & pharmaceutical industry Phase Occurring I Clinical pharmacology: pharmacokinetics And Pharmacodynamics Measured In Healthy volunteers II Exploratory Therapeutic Trials In Small numbers of closely monitored patients III Extensive clinical trials on large numbers of patients IV Post marketing surveillance-long-term studies of morbidity/mortality, multicentre studies to monitor usage of the drug.

ROLE OF PHARMACISTS IN CLINICAL TRIALS:

ROLE OF PHARMACISTS IN CLINICAL TRIALS We provide the necessary facilities required for proper storage of IMPs. We ensure there is constant supply of IMPs at all times. We provide the necessary information to patient regarding the drug administration. We document the review of the patient. We often run research projects to improve the outcomes. We conduct observational surveys that are aimed at investigating patients’ or physicians’ perspectives and attitudes towards medications.

CONCLUSION:

CONCLUSION Clinical trial study should be clarified with well defined objectives. Statistical analysis of the data should be generated. Clinical Findings of the new drug should have significant advantage over the existing therapy Their should be a good planning, organizing skills and appropriate resource allocation.

REFERENCE:

REFERENCE The Pharmacological Basis Of Therapeutics – Goodman and Gilman,11 th edition 2006- TATA McGRAW HILL, New Delhi, India Principles of Clinical Research- Dr. R.B. Ghool , 2 nd edition 2016- NIRALI PRAKASHAN, Pune , India Regulation of Clinical Trials – Rakesh Kumar Rishi , 1 st edition 2007- KONGPOSH PUBLICATION PVT. LTD. New Delhi, India Basic Pharmacology and Pharmacotherapeutics - Dr. Suresh R.Naik , 1 st edition 2017- NIRALI PRAKASHAN, Pune , India

authorStream Live Help