CLINICAL TRIAL PROTOCOL DESIGN ppt presentation.pptx

here i am sharing my ppt presentation on clinical trail protocol design

1. Clinical trial protocol design Presented by SUMAN DHAURIA REG NO- AU/2023/0010563 ROLL NO- PG/06/MPHARMP/2023/012 MPHARM (PHARMACEUTICS),1 ST SEM ,1 ST YEAR 1

2. Introduction Overview of clinical trail development Classification of clinical research design Members involve in clinical trail protocol design Elements of a protocol Conclusion References CONTENTS 2

3. INTRODUCTION C linical trail is a systemic investigation in human subjects for evaluating the safety and efficacy of any new drug . Trail protocols are the documents that describe the objectives, design, methodology, statistical considerations and aspects related to organization of clinical trail . General Information P rotocol title, protocol identifying number and date. Name and address of the sponsor and monitor . Name and title of the persons authorized to sign the protocol . Name ,title , address and telephone number of the sponsors and medical expert for the trail . Name and title of the investigator who is responsible for conducting the trail . Name, title , address and telephone number of the qualified physician who is responsible for all trail-site related medical decisions. Name and address of the clinical laboratory and other medical or technical department or institutions involve in the trail. 3

4. OVERVIEW OF CLINICAL DRUG DEVELOPMENT PHASE 0 - Treatment are given to a small number of objects to gather preliminary data pharmacokinetic parameters. PHASE I- Testing within a small groups of people (20-80) to determine safety and dosing of drug. PHASE II - are performed on larger groups of people(100-300) to assess how well the drug works . PHASE III- testing with large groups of people typically (1000- 3000) to determine safety and efficacy of a drug. PHASE IV – Post marketing surveillance – long term safety 4

5. CLINICAL RESEARCH DESIGN Experimental Studies Observational studies Cohort studies Case-control studies Uncontrolled Trail Controlled trail Cross-sectional studies Non - Randomized Randomized (RCTs) CLASSIFICATION OF CLINICAL RESEARCH DESIGN 5

6. MEMBERS INVOLVE IN CLINICAL TRAIL PROTOCOL DESIGN Chemist- know the physical and chemical properties of trail molecule. Pharmacologist- Should have knowledge about on animal dosing ,side effect ,effective dose for human adverse effect. Doctor / Physician – Complete knowledge of diseases Should have knowledge of clinical trail protocol as well as the logistics associated with clinical trail protocol. Statisticians- What different analysis will be done Ensure that collected data will support the analysis what forms will be data takes Data Entry Person- Perform data entry and Coding Investigators - Consultant (Scientist/ physician/Doctor), Objectives of the protocol Program Manager- Final writer co-ordination with all team member Execution of clinical trail 6

7. ELEMENTS OF A PROTOCOL:A CHECKLIST Title page- provide the full title of the trail , including if possible, a precise description of the trail objective . Table of contents- It has main heading , subheading, and appropriate page number. Introduction- include the description of the specific diagnosis and special subject characteristics for each disease to be investigated. Bibliography- all important reference should be sited appropriately. Objective - to evaluate the efficacy and safety of medication X VS medication Y in ( diagnosis of the disease ) as found in outpatient population . General - Contains a condensed summary of the protocol. Risks - is based on preclinical research in animals : the pharmacology and toxicology of the new drug is establish before being brought forward for trails in human. Confidentiality- If the subject getting enrolled for clinical trail his or her confidentiality should not compromised. Materials and Methods - Establish the number of subjects that must complete the trail and be a part of final statistical analysis. include a age range, gender, subject inclusion criteria ,subject exclusion criteria, trail procedures. 7

8. Trial Drugs – Include a complete description of the medication , lot number ,generic and brand name used in the trail. Assignment of trail drugs – two things must be establish Outline the method of randomization so that procedure is clear. make certain that the method of randomization is truly random so that a valid conclusion can be drawn. Dosage range- Describe the dosage range to be used in the trail. Dosage schedule – addresses when appropriate amount of drug are to be administered : once daily ,twice daily , every 4 hours , three times daily or given in the morning or evening Administration of trail drugs – describe how the drug is to be administered to or taken by the subject : with meals , before or after meals, with liquids or dissolved in specific juice . Labeling of the trail drugs – proper labeling of the medication is very important throughout the trail. Duration of the drug treatment – while protocol designing it becomes important to establish how long a drug should be evaluated to establish its efficacy and safety. Concomitant medications – all the records of the concomitant medication should be recorded in case report form. Case report forms- all the data on an individual subject during the course of clinical trail is recorded on a subjects CRF. Laboratory Assessments – through laboratory assessments the review of the data and safety of a drug can be assessed and measured. 8

9. Adverse experiences - all adverse experiences occurring in the trail must be reported on the drug reaction record provided in the subject case report forms . Statistical handling of data- must be final before an investigational trial begins. Overall Duration of the trail – the maximum allowable time required by an investigators to complete the evaluation of all subjects into the trail should be clearly stated . Institutional review board – a recognized and certified IRB must review the proposed clinical research protocol to determine the safety and anticipated benefits to subjects. Informed constant – ensure that no experimentation is carried out on people who are unaware to participate in an investigational clinical program. Monitoring – typically called clinical research associate who confirmed that all necessary information on the CRF has been recorded. Location of the trail- list the investigators(s) and address(s), telephone number(s) , where the trail is to be conducted. Location of the laboratory testing facilities- list of the names , addresses and telephone numbers of all test laboratories involved in the trail. Investigators obligations- written assurance form that agrees to conduct clinical trail according to protocol design . Signature page- a provide space for investigators signature and date the agreement is signed Amendments . 9

10. CONCLUSION Many approaches and different styles are useful in the development and preparation of a sound clinical research trail protocol . The foregoing guidelines can be modified to suit the applicants needs and objectives . No matter which patch is mapped out, it is imperative that investigators abide by the final protocol. Strict adherence to a well- designed protocol will result in research projects that reflect the stated objectives in the required amount of time leading to successful and definitive conclusions. 10

11. 1 1. Richard A. Guarino , Clinical Research protocols: Oxford pharmaceutical Resources , Inc, Totowa, New Jersey , USA 1984; 224- 245 . REFERENCES 11

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