Introduction To Clinical Research II

Introduction to Clinical Resear ch - II
By Benhur Pradeep Pradeep.ben84@gmail.com
www.myclinicalresearchbook.blogspot.com
What is Clinical Research

A systematic observational and experimental biomedical studies performed in human sub e cts to test new drugs or combination of drugs or devices or biologics for its safety and thera peutic uses or new approaches to surgery or radiotherapy or procedures to improve the dia gnosis of disease and the !uality life of the p atient.
Purpose of Research
"ntended to increase knowledge about how w ell a diagnostic test or treatment works in a p articular patient population. #o test hypothesis formulated from observatio ns and or intuition. $ltimately to understand better one%s world a nd make &'ense of it(.
%e& Drug Development Proce ss Full Early Life Cycle

Research Development
Preclinical rials Clinical rial Phase I
Development
Phase II! Phase II"
Management
Phase III Phase I#
Discovery Phase
Candidate Profiling Phase
Phase """ ,heck Point
'ubmission *ecision Point
'elected for Proof of ,oncept
)esearch #arget *iscovery of +ead ,ompound 'election of 'uitable ,andidate
,andidate 'election Point
3ull *evelopment Point
*evelopment *ecision Point
"4* R$D Preclinical

+ab testing Animal 'tudies #oxicology 'tudies etc.-.
4*A Clinical ." / ""0

Biological #ests and Pharmacological test in humans )egulatory ,learance
Clinical ."""/"10
)egistration with 2ealth Authorities Preparation for +aunch +aunch and 'ales
#reatment of all fairly and all e5ually share benefits and risks Potential conflict between good of society 1s. individual
7 ethical principles guide clinical research
Ethical %orms in Clinical Res earch
)espect for Persons
#reatment of person as autonomous
Beneficenc e
6ustice
Ethical %orms of Clinical rial s

'ound study designs take into account8
)andomi9ation or sharing of risks Proper use of placebo Processes to monitor safety of )x:#x ,ompetent investigators "nformed consent ;5uitable selection of participants ,ompensation for study related in uries
"ndividuals with targeted disease?@@=7@@ 'ub ects
2ealthy 1olunteers or individuals with targeted disease?@=>@@ 'ub ects Phase I BA=B; studiesPharmacokineticsPharmacodynamics
;valuate of effectiveness
*etermine metabolic and pharmacological actions- <aximum tolerated doses
$p to > <onth
Clinical Research - Phases
*osage intervals;fficacy and safety)isk=Benefit information Phase III
'everal <onths
*rug=*isease interaction *rug=*rug interactions Phase II 'ub ect safety
Phase I#
"ndividuals with targeted disease as well as new age groups- genders etc.>@@@%s 'ub ects
"ndividuals with targeted disease>@@%s B >@@@%s 'ub ects
<onitor ongoing safety in large population
Additional information on effectiveness;valuate overall risk= benefit ratio
'everal Aears
Cngoing review
;pidemiological dataPharmacoeconomics
<a or players in )esearch team

"nvestigator ,linical )esearch Associate ,linical )esearch ,oordinator *ata <anager 'tatistician Patients ")B )egulatory Body
Principal "nvestigator
A person responsible for the conduct of the clinic al trial at a trial site. "f a trial is conducted by a te am of individuals at a trial site- the investigator is the responsible leader of the team and may be c alled the principal investigator.
)esponsibilities 8 "nvestigator
Investigators 'ualifications !de(uacy of Resources Medical Care of )tudy Participants Communication &ith the IR" * IEC Compliance &ith the Protocol Investigational Product care Randomi+ation $ un,inding he Informed Consent Records and Reports Progress Reports )afety Reporting )topping or suspending a study Final report ,y investigator
,),
Person who handles most of the administrative responsibiliti es of a clinical trial- acts as liaison between investigative sit e and sponsor- and reviews all data and records before a m onitor%s visit. 3unctions as extension of "nvestigator. "nvolved in operational duties B recruiting- scheduling- comp leting ,)3%s- administering tests.
,)A .<onitor0
A person appointed by the 'ponsor or ,ontra ct )esearch Crganisation .,)C0 for monitori ng and reporting the progress of the trial and for verification of data. #he monitor ensures that the trial is conducte d- recorded and reported in accordance with t he Protocol- 'tandard Cperating Procedures .'CPs0- Dood ,linical Practice .D,P0 and th e applicable regulatory re5uirements.
)esponsibilities8 <onitor
<ain line of communication between sponsor and site 'ite feasibility #raining and support to site staff / selection Protocol / D,P ,ompliance *ocument completeness / maintenance 'ource *ata 1erification #rial material accounting ;nsure timely A; / 'A; reporting <onitoring reports / other office documentations Prepare and assist in ")B- )egulatory and internal audit or inspection Assist in ")B and )egulatory 'ubmission Assist in ")B and )egulatory 'ubmission
)tudy )tart -p
Protocol Level Feasi,ility Investigator )election Process Conducting Pre )tudy #isits
)ite )tartup
Investigators Meeting )ite Initiation )ite Monitoring )tudy Close out
)tudy Conduct )tudy Completion

3easibility 'tudies
Protocol feasibility8 #o assess from the region.s0: country.ies0 where the clinical study is to be con ducted- agreement on important study criteria lik e inclusion exclusion criteria- comparator drug- a nd study procedures outlined in the Protocol 'yn opsis- to prevent the need for protocol amendm ents later in the planning process A secondary ob ective is to provide information t o support finali9ation of the country:region alloca tion
3easibility 'tudies
'ite feasibility8 involves assessing site potential based on multivariate factors like Principal "nves tigators experience / interest in ,linical )esearc h- patient inflow- accessibility to the site- availabil ity of patients that meet the study criteria- and ot her related factors that affect the accrual rates a nd proper conduct of study related activities. #his is done to ensure that appropriate sites:Pri ncipal "nvestigators are identified
)ite )election
"t can be defined as a systematic planned process to evaluate a nd select an investigator and site for conduct of clinical trial 3actors involved in selection
)eputation in field 3acilities desirable for trial conduct Access to patient population Accessible geographic location Anticipated time for initiation and completion of trial )elationship with sponsor Budgetary factors Past experience ;xperienced staff ;,Bability to process protocols fairly and expeditiously
Investigator Meeting
Purpose
Achieve uniformity in approach by all investigators )eview and discuss the protocol Answer 5uestions Denerate enthusiasm Det everyone to know each other and develop a sens e of teamwork and trust )eview potential difficulties- issues and problems )eview administrative ground rules
)ite Initiation
'tudy initiation is done to review protocol- proce sses and procedures to ensure that all site perso nnel understand re5uirements of trial 'ites are initiated after all regulatory / ethical do cumentation is complete- after "P and other supp lies are shipped and before any patients are enr olled
Monitoring
Purpose E #o verify
protection of rights and well=being of sub ects reported trial data is accurate- complete- and verifiabl e trial is in compliance with8 Protocol and amendments )egulatory re5uirements ;nrolment *rug supply
)tudy Close .ut

After ensuring the study is complete All ,)3 received All study material is accounted for All investigational product is accounted for and b alance returned to sponsor ;nsure payment completion
/ey Issues
)tart -p
*elegate responsibilities ;ducate research team ;nrollment plan 'tudy documents
Conduct
Protocol compliance *ocumentation )ecord retention #rial drug accountability 'afety reporting
Close .ut
3inal drug accountability Preparation of records for archiving 'torage or destruction of lab samples *ata 5uery resolution 4otification to governing regulatory body
)ite Management
A structured / planned approach to manage vari ous research activities:functions at a site to ensu re execution through compliance and strict adhe rence to safety standards =through periodic moni toring per pre=determined:planned monitoring pl Design Close out Reporting an.
Feasi,ilit y )tudy )tart up Follo& up E0ecutio n Pu,licati on
)ite Management
)tudy Documents
"nvestigator%s Boucher Protocol "nformed ,onsent 3orm ,ase )eport 3orm 3inancial *isclosure 3orm ;, Approval +etter ,linical #rial Agreements and Budget +ab 4ormal )anges 'ample +abels Pre trial <onitoring )eport 'igned Agreements between ? parties.
Process Flo&
Pre-study planning 2Personnel1 .ther resources1 EC approvals etc314 !greements Closing meeting1 Evaluation of the study Close the data1 dispatch of the data archiving Investigators meeting1 practical planning1 training
Ethics1 Feasi,ility significance
)tudy Protocol Central La,
Proposal of study
Conduct of study5 Recruitment of the participants1 Informed consent1 Clinical e0aminations1 )pecimen collection1 Dispatch1 Documentation
Data analysis Correction
'ueries Monitoring
Thank you

Introduction To Clinical Research II

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Introduction to Clinical Resear ch - II

By Benhur Pradeep Pradeep.ben84@gmail.com

What is Clinical Research

%e& Drug Development Proce ss Full Early Life Cycle

Candidate Profiling Phase

Phase """ ,heck Point

'ubmission *ecision Point

'elected for Proof of ,oncept

)esearch #arget *iscovery of +ead ,ompound 'election of 'uitable ,andidate

,andidate 'election Point

3ull *evelopment Point

*evelopment *ecision Point

"4* R$D Preclinical

4*A Clinical ." / ""0

7 ethical principles guide clinical research

Ethical %orms in Clinical Res earch

)espect for Persons

#reatment of person as autonomous

Ethical %orms of Clinical rial s

"ndividuals with targeted disease?@@=7@@ 'ub ects

*etermine metabolic and pharmacological actions- <aximum tolerated doses

Clinical Research - Phases

*osage intervals;fficacy and safety)isk=Benefit information Phase III

*rug=*isease interaction *rug=*rug interactions Phase II 'ub ect safety

"ndividuals with targeted disease>@@%s B >@@@%s 'ub ects

<onitor ongoing safety in large population

Additional information on effectiveness;valuate overall risk= benefit ratio

<a or players in )esearch team

)tudy Conduct )tudy Completion

)tudy Close .ut

Ethics1 Feasi,ility significance

)tudy Protocol Central La,

Data analysis Correction

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rug=isease interaction rug=rug interactions Phase II 'ub ect safety