This document outlines the design of clinical trial protocols, detailing their purpose, structure, and the roles of team members involved. It covers the phases of clinical drug development, various research designs, and essential protocol elements to ensure safety and efficacy in drug testing. Conclusions emphasize the importance of adhering to a well-structured protocol for effective research outcomes.

1. Clinical trial protocol design
Presented by
SUMAN DHAURIA
REG NO- AU/2023/0010563
ROLL NO- PG/06/MPHARMP/2023/012
MPHARM (PHARMACEUTICS),1ST SEM ,1ST 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
2

3. INTRODUCTION
 Clinical 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
 Protocol 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

12. 12