Clinical Research

By:
Dhara Thakkar
 Introduction
• A Systemic obversvational and experimental biomedical studies
performed in human subjects to test new drugs or combination of
drugs or device or biologics for its safety and therapeutic uses or
new approached to surgery or radiotherapy or procedures to
improve the diagnosis of diseases and the quality life of patient.
 Candidate Clinical Life Cycle
Research Early Development Full
PhaseDevelopment
New Drug Development Process
Preclinical
Discovery Phase Profiling Trials Phase IIA Phase IIB Phase III Phase IV
Phase
Trials
I Management

R&D Preclinical Clinical (I & II) Clinical (III & IV)

• Research Target
• Discovery of lead
compound
• Selection of Suitable
Candidate
• Lab Testing • Biology tests and • Registration with
• Animal Studies pharmacological Health authorities.
• Toxicology Studies test in humans. • Preparation for
etc • Regulatory launch
Clearance • Launch and Sales.
 pharmacolo
information on
ongoing
effectiveness,

benefits ratio.
Determine

effectiveness
Maximum
metabolic

in large
BA-BE Studies,

of
Drug-disease interaction

tolerated
risk-
Dosage intervals,

actions,
Additional Phases of Clinical Research

doses
Evaluate
population
Evaluate
gical
and
Pharmacokinetics,
drur-drug interaction
epidemiological data
Efficacy and Safety,

overall
pharmacoeconomics
Pharmacodynamics
subject safety

Monitor
safety
Risk- Benefits information
Phase I II
Phase

Individuals
Volunteers
individuals
Phase III IV
Phase

subjects.

disease,
targeted

Healthy
subjects

Targeted
20-100

disease,
targeted
1000’s Subjects

Indiviuals
200-300

Individuals with
100’s-1000’s

asorwell as new
with
genders
age groups,
Subjects
Up to 1 Month

Targeted
Several Months

disease,

with
Years
Saveralreview
Ongoing

disease
etc.

with
 Protocol Level

Study Start Up
Feasibility

Investigator
Selection Process

Conducting Pre
Study Visits
Site Startup

Investigators
Meeting

Site Initiation

Site Monitoring

Site Close Out

Study Conduct

Study Completion
 Feasibility Studies
• Protocol feasibility :- To assess from the region(s)/ country(ies)
where the clinical study is to be conducted, agreement on
important study criteria like inclusion exculsion criteria,
comparator drug and study procedures outlined in the protocol
synopsis, to prevent the need for protocol amendments later in
the planning process.
• A secondary objective is to provide information to support
finalization of the country/ region allocation.
 Feasibility Studies
• Site feasibility: involves assessing site potential based on
multivaries factors like principal investigators experience &
interest in clinical research, patient inflow, accessibility to the site,
availability of patients that meet the study criterua and other
related factors that affect the accrual rates and proper conduct of
study related activites.
• this is done to ensure that appropriate sites/ principal investigator
are indentified.
 Site Selection
• It can be defined as a systematic planned process to evaluate and select an
investigator and site for conduct of clinical trial.
• Factors involved in selection are:-
– Reputation in field
– Facilities desirable for trial conduct
– Access to patient population.
– accessible geographic location
– anticipated time for initiation and completion of trial.
– Relationship with sponsor
– budgetary factors
– past experience
– experienced staff
– EC- abilibty to process protocols fairly and expeditiously.
 Site Initiation
• Study initiation is done to review protocol,processes and
procedures to ensure that all site personnel understanf
requirements of trial.
• Site are initiated after all regulatory and ethical
documentation is complete, after IP and other supplies
are shipped and before any patients are enrolled.
 Monitoring Visits by CRA
• The purpose of this visit is to verify inclusive exclusive
criteria and documentation as per protocol requirement,
protocol deviation if there are any, SAE documentation
and their reports.
• They also verify protection of right and wellbeing of
subjects through ICF, reported trial data is accurate,
complete and verifiable, trial is in compliance with protocol
and amendments, regulatory requirements, enrollment of
subject, drug supply and their visits according to protocol.
 Site Management
• A structured and planned approach to manage various
research activities / function at a site to ensure execution
through compliance and strict adhrence to safety
standards through periodic monitoring per pre-
determined/ planned monitoring plan.
Proposal of study
Process Flow
Study Protocol
Ethics, Feasibility
significance
Pre- Study planning
(personnel,other
Resources, EC
approvals etc.)

Conduct of Study :
Recuritment of the
participants, informed Investigators
Queries consent, clinical meeting, practical Agreements
examinations,Specimen planning, training
ccollections, Dispatch
Documentation

Close the data, Close meeting,

Data Analysis
dispatch of the Evaluation of
Correction
data archiving the study.
 Study Documents
• Investigator’s Boucher
• Protocol
• Informed Consent Form
• Case Report Form
• Financial Disclosure Form
• EC Approval Letter
• Clinical Trial Agreements and Budget
• Lab normal Ranges
• Sample Labels
• Pre- trials Monitorings Reports
• Signed Agreements between 2 Parties.
 Study Close Out
• After ensuring the study is complete
• All CRF received
• All Study material is accounted for
• All investigational product is accounted for and balance
returned to sponsor.
• Ensure payment completion.