UNDERSTANDING CLINICAL RESEARCH

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UNDERSTANDING CLINICAL RESEARCH AND CLINICAL TRIAL
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WHAT IS CLINICAL RESEARCH

• Clinical research is scientific study that
  involves people. Individuals volunteer to
  participate in carefully conducted studies which
  ultimately uncover improved methods and knowledge
  on screening, diagnoses, treatment and prevention
  of disease and on the promotion of health and
  health care.
• Clinical research can be observational (e.g.
  health economic research) or interventional (e.g.
  clinical trials).
• Improving standard care is one of the aims of
  clinical research

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TYPES OF CLINICAL RESEARCH
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WHAT IS A CLINICAL TRIAL

• Clinical trial means a systematic study of new
  drug(s) in human subject(s) to generate data for
  discovering and / or verifying the clinical,
  pharmacological (including pharmacodynamic and
  pharmacokinetic) and /or adverse effects with the
  objective of determining safety and / or efficacy
  of the new drug.
• Generally considered to be biomedical or
  health-related research studies in human beings
  that follow a pre-defined protocol

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WHAT IS A DRUG

• A substance intended for use in the diagnosis,
  cure, mitigation, treatment, or prevention of
  disease.
• A substance (other than food) intended to affect
  the structure or any function of the body.
• A substance intended for use as a component of a
  medicine but not a device or a component, part or
  accessory of a device.

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DRUG DISCOVERY
PRECLINCAL TESTING IN ANIMALS
CLINICAL TRIAL
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HOW DOES CLINICAL RESEARCH DIFFER FROM FROM
STANDARD CARE 

• The difference between clinical research and
  standard care is that clinical research
• involves human volunteers, these may be patients
  or can all be healthy individuals who are not
  suffering from an illness or condition. 
• Is carried out with the ultimate aim of improving
  standard care. The research may be testing an
  intervention (e.g. a product or procedure) or
  collecting data through interviews or
  observations about a topic such as patient
  experience, disease management etc.

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WHO CAN PARTICIPATE IN A CLINICAL TRIAL

• Before joining a clinical trial, a participant
  must qualify for the study
• Some research studies seek participants with
  illnesses or conditions to be studied in the
  clinical trial, while others need healthy
  participants
• It is important to note that inclusion and
  exclusion criteria are not used to reject people
  personally. Instead, the criteria are used to
  identify appropriate participants and keep them
  safe.
• The criteria help ensure that researchers will be
  able to answer the questions they plan to study

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WHAT HAPPENS DURING A CLINICAL TRIAL

• The clinical trial process depends on the kind of
  trial being conducted
• The clinical trial team includes doctors and
  nurses as well as social workers and other health
  care professionals who check the health of the
  participant at the beginning of the trial, give
  specific instructions for participating in the
  trial, monitor the participant carefully during
  the trial, and stay in touch after the trial is
  completed

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• Some clinical trials involve more tests doctor
  visits than the participant would normally have
  for an illness or condition
• Clinical trial participation is most successful
  when the protocol is carefully followed and there
  is frequent contact with the research staff

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HOW IS THE SAFETY OF THE PARTICIPANT PROTECTED

• Most clinical research is federally regulated
  with built in safeguards to protect the
  participants
• The trial follows a carefully controlled
  protocol, a study plan which details what
  researchers will do in the study
• As a clinical trial progresses, researchers
  report the results of the trial at scientific
  meetings, to medical journals, and to various
  government agencies
• Individual participants' names will remain secret
  and will not be mentioned in these reports

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WHAT SHOULD PEOPLE CONSIDER BEFORE PARTICIPATING
IN A TRIAL

• What is the purpose of the study?
• Who is going to be in the study?
• Why do researchers believe the experimental
  treatment being tested may be effective? Has it
  been tested before?
• What kinds of tests and experimental treatments
  are involved?
• How do the possible risks, side effects, and
  benefits in the study compare with my current
  treatment?
• How might this trial affect my daily life?

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• How long will the trial last?
• Will hospitalization be required?
• Who will pay for the experimental treatment?
• Will I be reimbursed for other expenses?
• What type of long-term follow up care is part of
  this study?
• How will I know that the experimental treatment
  is working? Will results of the trials be
  provided to me?
• Who will be in charge of my care?

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WHERE DO THE IDEAS FOR TRIALS COME FROM

• Ideas for clinical trials usually come from
  researchers
• After researchers test new therapies or
  procedures in the laboratory and in animal
  studies, the experimental treatments with the
  most promising laboratory results are moved into
  clinical trials
• During a trial, more and more information is
  gained about an experimental treatment, its risks
  and how well it may or may not work

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OBJECTIVES OF CLINICAL TRIAL

• The objectives should be clearly defined,
  stated in a manner that will allow the objectives
  to be investigated by a quantitative assessment
  of appropriate outcomes
• The objectives should include
• A precise statement of the degree of benefit
  expected from the intervention, as well as the
  duration of the benefit
• Clear statements of the time frame of the study
• A definition of the patients for whom the benefit
  is sought

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BENEFITS OF PARTICIPATING IN A CLINICAL TRIAL

• Clinical trials that are well-designed and
  well-executed are the best approach for eligible
  participants to
• Play an active role in their own health care
• Gain access to new research treatments before
  they are widely available
• Obtain expert medical care at leading health care
  facilities during the trial
• Help others by contributing to medical research

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RISKS OF PARTICIPATING IN A CLINICAL TRIAL

• There may be unpleasant, serious or even
  life-threatening side effects to experimental
  treatment
• The experimental treatment may not be effective
  for the participant
• The protocol may require more of their time and
  attention than would a non-protocol treatment,
  including trips to the study site, more
  treatments, hospital stays or complex dosage
  requirements

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GLOBAL SCENARIO OF CLINICAL RESEARCH

• CLINICAL TRIAL OVERVIEW
• The global clinical trials market is estimated to
  value at nearly US 44 Bn in 2019, and is
  expected to register a CAGR of 5.7. 
• The global clinical trials market is segmented on
  the basis of phases, study design,
  indications/symptoms, and region.

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• GLOBAL CLINICAL TRIAL MARKET DYNAMICS
• Increasing demand for new medical equipments and
  medicines among end users, coupled with growing
  investment for research and development
  activities for development of effective medicines
  are major factors driving growth of the global
  clinical trials market.
• In addition, increasing number of individuals
  suffering from chronic diseases as well as
  changing conditions and nature of certain types
  of chronic diseases is another factor anticipated
  to support growth of the global clinical trials
  market to significant extent.

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INDIAN SCENARIO OF CLINICAL RESEARCH

• India has long been identified as a major
  resource center for conducting clinical trials
  and data management services. Plus points include
  its large patient population, well-trained,
  enthusiastic and foreign-educated investigators,
  and significantly lower cost. 
• The average cost of Phase I/II/III trials in the
  US is over 20/50/100 million, respectively. But
  in India, one may do it at half (50-60) the
  said cost and 75 faster. Lowest per patient
  trial cost coupled with an extensive gene pool
  and extremely lower cost of technical services is
  doing the job here. 

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• What makes India a hot spot for researchers is
  the presence of treatment-naive patients with a
  wide spectrum of diseases spanning from
  Multidrug-resistant pneumonia, Hepatitis B,
  Diabetes, to rare cancers than in the West. 
• Volunteer enrollment is also high, as people
  believe that participation in research trials
  could offer them access to quality health care
  and medicines, which otherwise would not be
  affordable

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CAREER OPPORTUNITIES IN CLINICAL RESEARCH

• Clinical research is an attractive industry which
  foresees tremendous growth and job opportunities
  not only for trained medical, pharmaceutical and
  paramedical professionals, but also for
  regulatory authorities, government and the
  society at large.
• With the inflow of multinational players in
  research, the industry is poised to grow
  exponentially and open up new vistas of
  employment for a large number of people.

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• CANDIDATES CAN MAKE THEIR CAREER IN THE FIELDS OF
  
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• Contract Research Organizations (CRO)
• Pharmaceutical Industries
• Biotechnology Companies
• Medical Device Company
• Patient Recruitment Organisations (PRO)
• Clinical Data Management
• Regulatory Affairs
• Pharmacovigilance
• Medical Writing
• Central Lab
• Research Sites
• Auditing of Clinical Trials

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