Protocol Design

PROTOCOL DESIGN

Dr. JAYASHREE ICRI

DEFINITION AND PURPOSE 

  

A Document that describes the objectives,design,methodology and statistical considerations and organisation of a trial Background and rationale for the trial Protocol amendments Content and format-SOP

Why ,how,what

PROTOCOL  Protocol

to be comprehensive-users  Information to study site staff  Data collection and analysis.  Clinical study report

PROTOCOL –INPUTS  Staff

of the sponsor company  Regulatory affairs department  Marketing department  Medical literature  Investigators brochure  statistician

OBJECTIVES OF THE STUDY  Precise

and clearly defined  As few as possible  What can the results demonstrate – Primary objective – Secondary objective

PATIENT SELECTION  Criteria

for inclusion and exclusion  Inclusion – Evidence to confirm the diagnosis  Exclusion

– Concomitant medication – Concomitant disease – Contra-indications

TRIAL DESIGN  Study,phase,end-point

of study

– Comparator or non comparator – Cross-over or parallel group  Choice

of comparator

 Bias

– Selection or allocation bias – Observer bias

METHODOLOGY 

Treatment material – – – – – – – –

Blinding method Quantities Period of use Compliance checking Packaging Labelling Storage and handling Escape medication and concomitant medication

METHODOLOGY 

Patient management – – – – –



Schedule of events Investigations-central lab,relevant inv Adverse affects treatment-by ,to ,when Patient instructions Records and data collection-source documents,entry in to CRF , direct entry into CRF.

Assesment of efficacy and safety.

STATISTICAL CONSIDERATIONS  DESIGN  COMPARATOR-PROS  SAMPLE

AND CONS

SIZE  STATISTICAL ANALYSIS

ETHICAL CONSIDERATIONS  Basis

for the study should be ethical from subject’s point of view – Ensure safety – Invasive investigations – Use of placebo

 IC,confidentiality,compensation,

indemnity,audit and finance

ORGANISATION, PRACTICALITIES  Commitment

of all participants  Cultural variabilities

TRIAL ADMINISTRATION  Co

ordination – staff,monitor  Responsibility – regulatory authorities,maintain data,ADR monitor  Agreement – between company ,investigator,regulatory bodies.  Funding ALL ACCORDING TO COMPANY SOP.

PROTOCOL REVIEW AND SIGN -OFF  Circulated

for critical review  Protocol writer-editor with a team  Committee of individuals specified in the SOP

PROTOCOL AMENDMENTS  Minimum  Procedure

for dealing and tracking amendments are defined in SOP  Review and sign off, ethics committee approval