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1. INTRODUCTION TO
CLINICAL
RESEARCH
JULIUS
MATERN
Medical laboratory scientist
Clinicallabgurus.com

2. Agenda
• Introduction
• Clinical research and standard care
• Research ethics
• Study design
• Maintaining ethical standard ,data quality and uniformity in a
study
• Protocol
• SOPs
CLINICAL RESEARCH 2

3. Agenda
• Informed consent
CLINICAL RESEARCH 3

4. Introduction
Clinical research: Is the scientific study that involve people.
• Individual volunteer to participate in carefully conducted studies
which ultimately uncover improved methods and knowledge on
screening, diagnosis, treatment and prevention of diseases.
INTRODUCTION 4

5. Clinical
research can be
:
 Interventional
 Observational

6. Introduction
OBSERVATIONAL STUDIES
Are projects where there is no investigational products assigned to participants.
Example: Research on how therapies work, health economic research, Qualitative
research such as understanding patient experience
OBSERVATIONAL STUDIES 6

7. Introduction
INTERVENTIONAL STUDIES
Are controlled experiments like clinical trials where every participants is
allocated to the treatment /control group at the start of the study.
• Treatment group: Receive experimental intervention, treatment or tested drugs.
• Control group: Serve as reference/comparison group, do not receive experimental
Treatment ,may receive placebo(inactive substance)
INTERVENTIONAL STUDIES 7

8. introduction
Intervention can include drugs, cells and biological products,
surgical procedure devices, preventive care e.t.c
Studies can be
• Single center studies: Which is done in one location
• Multi-centered studies: Which is done in many sites
PRESENTATION TITLE 8

9. How does clinical Research
differ from standard care?
CLINICAL RESEARCH 9

10. Clinical research & Standard
care
• Clinical research : Involves volunteers who may patients or healthy
individuals who are not suffering from illness or condition.
• Clinical research is carried out with the aim of improving standard
care.
• Clinical research may involve control group depending on type of
research.
CLINICAL RESEARCH 10

11. Clinical research & Standard
care
• Clinical research must stick to protocol without deviations.
CLINICAL RESEARCH 11

12. Why do we perform clinical
Research ?
CLINICAL RESEARCH 12

13. Clinical research
Clinical research is performed to collect data on usual /unusual events,
conditions, population group to allow us to
• Observe treatment and health practices so that we can learn how
they can be improved.
• Test interventions to develop new drugs and vaccines and find new
uses of the existing therapies.
CLINICAL RESEARCH 13

14. Clinical research
• Learn more about specific disease so we can better understand how
to manage ,treat and prevent them.
Example: "1990's clinical trial showed that the progress of AIDs could
be delayed by combining antiretroviral drugs."
CLINICAL RESEARCH 14

15. The most reliable way of improving
health outcomes is through
continuous practice of clinical trial in
different people and communities
CLINICAL RESEARCH 15

16. MAIN PRINCIPLE OF
RESEARCH ETHICS
PRINCIPLE OF RESEARCH ETHICS 16

17. RESEARCH ETHICS
• RESEARCH ETHICS: Refers to the set of principles and guidelines
that govern the responsible conduct of research.
• It involve ensuring that research is conducted with integrity,
honesty and respect for the right and well beings of participants.
CLINICAL RESEARCH 17

18. JUSTICE
Belmont report list 3 basic principles of research ethics
• JUSTICE
This principle emphasize the fair distribution of benefits and
burden of the research.
It require researcher treat individuals fairly and avoid exploitation
of vulnerable groups
CLINICAL RESEARCH 18

19. Cont...
Example: When selecting participants for research study ,researcher
must ensure the recruitment process is fair and does not
disproportionate include or exclude certain group.
CLINICAL RESEARCH 19

20. Beneficence
• Beneficence Require researcher to maximize benefit and minimize
potential harms to participants.
It involves commitment to promote well being of individuals and
ensuring that research has favorable balance of potential benefits over
risks.
CLINICAL RESEARCH 20

21. Beneficence
Example
• In clinical trial testing a new drug , researcher must careful weigh
the potential benefit of drug in treating a medical conditions against
the possible side effect or risks to participants.
CLINICAL RESEARCH 21

22. Respect of autonomy
Individual freedom to choose and act must be respected and
vulnerable individuals must be protected.
This principle emphasizes the importance of recognizing autonomy
and dignity of individuals. It require obtaining consent from the
research participants , ensure they understand the nature of study, its
potential risks and benefits and that participation is voluntary.
CLINICAL RESEARCH 22

23. Others-Non-Maleficence
This is often started as " Do not harm"
This principle emphasize to avoid harm intentionally and reduce
potential risk of any action or intervention
CLINICAL RESEARCH 23

24. Research governance
It is the broad range of regulations and standards of good practice that
are in place to ensure participants are protected and quality is assured
across all aspects of clinical research.
CLINICAL RESEARCH 24

25. Research governance
It is the broad range of regulations and standards of good practice that
are in place to ensure participants are protected and quality is assured
across all aspects of clinical research.
CLINICAL RESEARCH 25

26. CONSENT
What is informed consent and why is it needed?
• Informed consent: Is the main mechanism for ensuring an
individual's right are protected .
• Informed consent involve explaining to the
potential participants about all the study related activities that are
beyond standard care and ask that person consent to be included in
the study. CLINICAL RESEARCH 26

27. CONSENT
Informed consent by International conference on harmonization
principle of good clinical practice(ICH GCP) 1996 guideline defined as
"Is the process by which a person freely confirm their willingness to
participate in clinical research after having been informed of all parts of
the study that are relevant to the individual decision to participate"
CLINICAL RESEARCH 27

28. CONSENT
Process of obtaining consent should be ongoing process that is not a
single event (Reading and signing)
When taking consent from participants the investigator should ??
• Full inform the potential participants of all applicable parts of the study
such as purpose, duration, required procedures, and key contacts.
CLINICAL RESEARCH 28

29. CONSENT
• Be sensitive to the needs of individuals who are part of vulnerable
groups example children's, poor, little knowledge
• Explain benefit and risks involved in taking study.
• Encourage if participants agree to participate they can always ask the
research team for additional information throughout the study
CLINICAL RESEARCH 29

30. CONSENT
• Explain that is participants changes mind they are free to leave and no
obligation to explain why they are leaving
• Being able to communicate in simple non-technical words in a way
person can understand.
• Informed consent should be documented by means of written, signed
and dated informed consent form.
CLINICAL RESEARCH 30

31. MEANS OF TAKING CONSENT
• Incase participants can not sign by himself then someone who is
independent from the study should sign as witness that the individual
agreed to participates.
• No procedure are allowed to take place before the informed consent
process is complete and informed document is signed
CLINICAL RESEARCH 31

32. CONSENT
• It is important that participants understand that informed consent form
is not a contract.
In some cases community can not sign form due to illiteracy or other
issue then
• Consent form will be based first on approval of the project by
community leaders , then verbal consent to the individual.
CLINICAL RESEARCH 32

33. CONSENT
In case of high illiteracy the witness signs the consent form to confirm
that they have observed the participants has read for them and they
have understood and had all questions answered.
So witness sign and participants provide their thumbprint with the
person taking consent writing their names and date.
Other method used is taking audio and video recording of the consent
process CLINICAL RESEARCH 33

34. STUDY DESIGN
Design used in any of the study is dependent on question being
investigated.
Common used study designs are
• Cohort studies
• Case control studies
CLINICAL RESEARCH 34

35. STUDY DESIGN
• Cross sectional study
• Case report and
• Clinical trial
CLINICAL RESEARCH 35

36. COHORT STUDIES
• Participants are grouped based on their shared characteristics(cohort)
and followed over time to assess the development of specific outcome
• Example: Following a group of individual with history of exposure to a
particular risk factor and compare their health outcome to the group
without that exposure.
CLINICAL RESEARCH 36

37. COHORT STUDIES
• This type of study design allow you to collect specific data over a
given time and allow for interaction with participants.
• I is expensive
• Can take years to complete
CLINICAL RESEARCH 37

38. CASE CONTROL STUDIES
• Participants with particular condition (cases) are compared with those
without conditions(control) to identify factor associated with condition.
• Example: Investigating factor associated with rare disease by
comparing individuals diagnosed with disease(cases) to those without
diseases(controls)
CLINICAL RESEARCH 38

39. CASE CONTROL STUDIES
• Aim is to uncover what caused the outcomes in one group but not the
other
• All participants should be recruited from the same population.
• Relative in expensive
• Subjected to recall bias(those group with disease may remember
intervention or exposure more easily than those in control group
39

40. CROSS SECTIONAL STUDY
• Data is collected from participants at a single point in time to examine
relationship between variables or characteristics.
• Example: Surveying a population to determine prevalence of certain
health condition and their association with demographic factors.
• It is quick and easy but it doesn’t allow distinction to be made between
cause and effect
CLINICAL RESEARCH 40

41. CASE REPORT
• Case report are the detailed histories of single case.
• They provide symptoms, signs, diagnosis, treatment and follow up of
an individual patient.
• Advantage is that it allow us to uncover unexpected effect, new
disease
• Lead to increase knowledge
CLINICAL RESEARCH 41

42. RANDOMIZED CLINICAL TRIAL
• Participants are randomly assigned to either an experimental group
that receive the intervention or control group that does not.
• Can be conducted using health volunteer or patients depending on
what trial is investigating
CLINICAL RESEARCH 42

43. RANDOMIZED CLINICAL TRIAL
• Example Testing a new drug by randomly assigning participants to
receive either drug(experimental group) or placebo(control group)
CLINICAL RESEARCH 43

44. PHASES OF RCT
• Randomized clinical trial usually has 4 phases which are
• PHASE I – Primary goal of phase one is to assess the safety and
dosage of new intervention or drug in a small group of healthy
volunteer or individuals with the target condition.
• It is aim at determining the safe dosage range and identify the side
effect
CLINICAL RESEARCH 44

45. PHASE I
• It is usually involve less than 100 participants.
KEY ACTIVITIES
• Determining the maximum tolerant dose
• Monitor for adverse effect
• Assessing how intervention is metabolized and excreted
CLINICAL RESEARCH 45

46. PHASE II
• Aim to further evaluate the safety and effectiveness of the intervention
in a large group of participants with the target condition.
• No more than few hundreds participants
• Continue to monitor effect and side effects.
CLINICAL RESEARCH 46

47. PHASE III
• On large group of people to confirm effectiveness and monitor minor
side effects .
• Often in comparison to existing standards treatments or
placebo /make comparison with commonly used treatments.
CLINICAL RESEARCH 47

48. PHASE IV
• Occur after intervention has received regulatory approval
• Focus on continue safety monitoring and gathering additional
information's about intervention's long term risks and benefits
CLINICAL RESEARCH 48

49. RCT
• RCT is termed as gold standard of clinical research as it eliminates
bias.
CLINICAL RESEARCH 49

50. Maintaining high ethical
standards data quality and
uniformity in a study
• How high ethical standards ,quality and uniformity in the study
ensured?
To ensure high ethical we use
• Protocol
• SOPs or manual operations
CLINICAL RESEARCH 50

51. Protocol
Provide background and justification for the study ,it cover issues like
• Design
• Study timetable
• Methodology
• Statistical consideration and organization
CLINICAL RESEARCH 51

52. SOPs
• Ensure uniformity of performance
• Ensure tasks will be performed the same way each time is undertaken
• Identify person responsible for each tasks
• Describe the study procedures and how they are completed
• Train staff into the role
• Monitor site performance CLINICAL RESEARCH 52

53. SOPs
• Note: All research study staff must be trained in and have access to
copy of the SOPs
• It is essential that each member follows the study SOPs to ensure
protocol is being followed to ensure participants safety.
CLINICAL RESEARCH 53

54. SOPs
• SOPs should be reviewed regularly at least annually to ensure any
listed regulations are up to date
• SOPs is needed to avoid variations in how a task is carried out which
could lead to inconsistence ,inaccurate or misleading data
• Uniformity of the study and quality assurance procedures are ensured
by implementation and use of the SOPs
CLINICAL RESEARCH 54

55. SOPs
• SOPs identify who is responsible for which task , provide step by step
to be followed for the study procedures.
• Help staff to carry out a particular task in the same way and monitor
site performance
CLINICAL RESEARCH 55

56. INFORMED CONSENT
• Informed consent is the first and foremost a continue process.
• This includes person voluntarily agreeing to participate in a
research study after being fully informed about it via
verbal discussion with the study staff ,then followed
by documentation in a written, signed and dated informed consent
form.
PRESENTATION TITLE 56

57. Cont...
• Participants will be notified of any changes to the study if it will be
there.
• While documentation of informed consent is required in most clinical
studies, there occasions when alternative of written informed
consent is obtained from the institutional review board for some or
all study participants.
PRESENTATION TITLE 57

58. Cont...
• You need to consult the local review board for determining when it is
appropriate to waive the requirement for written consent.
• Informed consent should contain all of the information that the
person needs to make informed decision about taking part in the
study.
PRESENTATION TITLE 58

59. Cont...
• Participants must sign and date the informed document before
taking part in any study procedures.
• Signing consent form is not the final step in the informed consent
process since any time participants may withdraw consent and
decline to participate in the study at any time before or after signing
the consent document.
PRESENTATION TITLE 59

60. INFORMED CONSENT DOCUMENT
Informed document should cover major and important parts as follow
• STUDY PURPOSE: The consent document must state the trial
involve research and must state the purpose of the trial.
• STUDY TREATMENT AND RANDOMIZATION: Consent document
must state The trial treatment(s) and the probability for
random assignment to each treatment (if a randomized clinical trial)
PRESENTATION TITLE 60

61. INFORMED CONSENT
DOCUMENT
• STUDY PROCEDURES: The consent document must state
The trial procedures to be followed, including invasive procedures.
Participants responsibilities
Those aspect of the trial that are experimental
Expected duration of the participants involvement in the trial.
PRESENTATION TITLE 61

62. INFORMED CONSENT DOCUMENT
• RISKS OF TAKING PART IN STUDY: Consent document must
state
The reasonably foreseeable risks to the participants and when
applicable to an embryo, fetus or nursing infant.
• BENEFIT OF TAKING PART IN THE STUDY: The reasonably
expected benefits ,if there is no intended clinical benefits to the
participants , participants must be aware of this
CLINICAL RESEARCH 62

63. INFORMED CONSENT DOCUMENT
• STUDY CONTACTS: The consent document must state
The person to contact for further information regarding the trial and the
rights of trial participants in the event of trial related injury
• DURATION OF PARTICIPATION AND NUMBER OF PEOPLE
TAKING PART : Document must state expected duration of the
participation in the trial and approximate number of the participants
involved in the trial. 63

64. INFORMED CONSENT DOCUMENT
• Those are some few key points to be involved in any consent form
NOTE: A consent form should be written in non-technical language that
participants would understand also should be written in language
consistent with the participants education level ,cultural views and
familiarity with research.
64

65. SPECIAL REQUIREMENTS CONCERNING THE
CONSENT OF PREGNANT WOMEN
When research activities involves pregnant women as participants
• Both mother and father must be informed about any potential impact
of the research on the fetus.
• Both father and mother must consent to the women's participation in
the research.
PRESENTATION TITLE 65

66. SPECIAL REQUIREMENTS CONCERNING THE
CONSENT OF PREGNANT WOMEN
However father consent is not required in the following circumstances.
• The purpose of the research is to meet the need of the mother
• The father identity cannot be determined
• The father is not reasonable available
• The pregnancy resulted from rape
PRESENTATION TITLE 66

67. SPECIAL REQUIREMENTS CONCERNING THE
CONSENT OF PREGNANT WOMEN
• Consent of a legally acceptable representative of either or both
parents does not suffice for informed consent.
PRESENTATION TITLE 67

68. SPECIAL REQUIREMENTS CONCERNING THE
CONSENT OF CHILDREN
• The legal age for consent in most states is 18 ,so person under 18
are considered minors.
• When children or minors are involved in research both ASSENT of
the child or minor and the PERMISSION of his or her parent(s) are
usually required.
CLINICAL RESEARCH 68

69. SPECIAL REQUIREMENTS CONCERNING THE
CONSENT OF CHILDREN
• PERMISSION: Means the agreement of the parent(s) or a legal
guardian to the participation of their child or ward in research
• ASSENT: Means a child's agreement to participate in research
.Failure to object is not assent
In most cases both parents must give their permission for their child or
minors participation in research
CLINICAL RESEARCH 69

70. Thank you
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