1. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
Clinical Trials

2. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
Clinical Trials are the best way to test
whether a treatment is effective and
better than other treatments (or no
treatment).
New treatments or drugs for
diseases‘ prevention, early diagnosis
or cure are examined in a safe and
efficient way.

3. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
Clinical studies are the fastest
and safest way to find innovative
therapies and new effective
treatments.

4. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
As a patient, you might be
considering enrolling in a clinical
trial or you might be offered to by
your physician.
If you are interested in the
development of innovative
treatments, you can also be
proactive and increase your
knowuledge about clinical trials
by yourself.

5. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Introduction
This tutorial will teach you the
most important facts about
clinical trials.
Finally we hope to answer any
questions you might have
about this topic.

6. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical
Trials?

7. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical research aims to improve
existing therapies or to replace
them with new and better ones.
Before a new treatment is made
available for patients, it must be
tested in a clinical trial for safety
and efficacy.

8. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials are designed for
learning more about the
positive and negative effects
of a treatment.
Treatment‘s efficacy and
safety, however, can be totally
assessed only by long-term
use on patients in the daily
clinical practice.

9. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Before being tested on
patients in a clinical trial, new
treatments must be carefully
evaluted in the laboratory.
If labs results are promising, a
clinical trial can be designed
for studing efficacy and safety
of the new treatment.

10. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials are the only effective
and safe way to test a treatment
after it has been carefully
evalutated by laboratory analyses.
Clinical trials aim to assess not
only treatments‘ efficacy but also
all the possible risks.

11. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
New therapies need to be
statistically evaluated by clinical
trials on very large group of
similar patients (differences
among patients affected by the
same disease can quite big and
could affect the results of the
clinical trial).
Results must be systematically
reviewed and carefully
analysed.

12. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False

13. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False
Your choice is
correct!

14. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
Clinical trials conducted on large
number of patients are essential for
proving the safety and the efficacy
of a new therapy or drug.
True False
Your choice is
not correct!

15. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
New treatments that have
been tested in a laboratory
have no risks whatsoever
when used in clinical trials.
True False

16. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
If a new treatment has been
previously tested in laboratory
there is no risks whatsoever
when used in clinical trials.
True False
Correct! Laboratory tests help
designing new treatments but
cannot reveal risks for patients.

17. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What are Clinical Trials?
If a new treatment has been
previously tested in laboratory
there is no risks whatsoever
when used in clinical trials.
True False
Wrong!
New treatments can always
have unknown and
unpredictable risks.

18. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials
Important?

19. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials help developing
new and better treatments for
patients.
Assessing safety and efficacy of
a new therapy is a very rigorous
and long process. For this
reason, new treatments usually
take a lot of time before
becoming available for the
public.

20. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials aim to enhance new
or already existing treatment
strategies or to check out new
therapeutic/diagnostic methods.

21. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Why are Clinical Trials important?
Clinical trials also important because
they investigate the causes of
diseases and their findings are
essential for enhancing the medical
progress.

22. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Are you considering
enrolling in a Clinical
Trial?

23. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in Clinical Trials?
Patients enroll in clinical trials
for several reasons.
Many people hope to benefit
from having access to a new
treatment.

24. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
In order to avoid disappointment
you should remember that new
treatments are not automatically
better than standard ones in
terms of efficacy and safety (and
that‘s why a clinical trial is
needed!).

25. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Patients should be selected for a
clinical trial if they are likely to
benefit the the most from the new
treatment.
Clinical studies give them the
opportunity to get innovative and
experimental therapies not yet
available on the market.This is
especially true for diseases with no-
known cure.

26. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Some other participants wish to
contribute to medical research
and to help other patients by
voluntarily participating to a
clinical trial.

27. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False

28. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False
No!
Even if many clinical trials result in an
improvement of a therapy there is no
guarantee for success.
A new therapy could be as good as or
even worse the standard treatment.

29. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Clinical trials‘ results always represent
an improvement of the standard
available treatment.
True False
Yes!
Most but NOT all of the treatments
have turned out to be better than
the standard treatment.

30. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False

31. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False
Your choice is not correct.
Reseachers always conduct a
clinical trial to improve a
treatment or to find at least an
equally good one.

32. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Enrolling in a Clinical Trial?
Researchers conducting a clinical trial
hope that their new treatment is better or
at least as good as the standard one
already available.
True False
Correct!
Although disappointment is possible,
researchers always intend to achieve
an improved or at least an equally
good treatment.

33. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial
Process
(change on the right!)

34. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Every clinical trial is designed to
answer a series of scientific
questions about the tested
treatment.
The quality of a clinical trial and its
results heavily depends on a well
chosen clinical trial design.

35. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
When conducting a clinical trials,
researchers must always follow a
written study plan also called study
protocol.
The protocol both ensure patients‘
safety and is essential for achieving
high quality and reliable results.

36. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Some clinical trials are conducted
on one group of patients only, whilst
others compare two groups.
Patients of different groups must be
as much as possible similar e.g.
they must have the same medical
conditions and the same stadium of
the disease.

37. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Patients are assigned to one group or
another (therefore receiving the new
treatment or the standard one) by a
method called randomisation, i.e the
choice is made by chance through a
random generator.

38. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
When the study is conducted on two
group of patients, the first group is
called “controI group“ and often
receive the standard available
therapy, while the other one is called
“active group“ and is given the new
treatment.
This type of clinical trial is called
controlled trial.

39. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group in a clinical trial is
treated with the same care as the
active.
If possible, neither the researchers nor
the patients should know which group
every participant has been assigned.
This special type of randomised trial is
called double-blind randomised trial
and ensure equal treatments for both
groups.

40. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
For many diseases there are no
standard treatment available yet. In
this case the control group receive
a dummy treatment called placebo
such as a sugar pill.
Important: For ethical reasons,
placebo control groups are not
allowed if a treatment already exists
and patients can benefit from it!

41. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False

42. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False
Correct!

43. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Clinical trials firstly consider patients‘
safety and well being when testing a new
treatment.
True False
Incorrect!
Clinical trials are firstly commited
to patients‘ safety and only in
second instance to scientific
results.

44. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False

45. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False
Incorrect!
Before the clinical trial is completed, it
is not possible to tell which treatment
will be better, whether the standard
therapy or the new treatment.
Both treatments could be equally
good for the patient.

46. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
The control group always receives the
less effective treatment.
True False
Correct!
When starting a clinical trail,
researchers cannot know yet whether
the standard therapy or the new
treatment will be better. Both
treatments could be equally good.

47. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
For ethical reasons, if during a clinical
trials clearly one treatment clearly
shows to be better than the other one,
the study is stopped and all the
participants are given the same
treatment.

48. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
The Clinical Trial Process
Patients should only enroll in a clinical
trial after having clearly understood
the benefits they could get and risks
they might incur in.
It is therefore essential that patients
are given clear and exhaustive
information before they agree to
partecipate.

49. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent

50. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
The informed consent gives you all
the important information about any
aspects of the clinical trial before
deciding to enroll.

51. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
As a first step, every patient meets one
of the clinical trial researcher who will
explain in detail the possible benefits
but also risks in one-to-one talks.

52. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
After the meeting, the researcher will
hand you out the detailed information
about the trial in written form,
because you should carefully think
about a participation.
If you decides to enroll in, you must
return the informed consent signed
and personally dated.
Of course you always have the right
to refuse taking part in the trial.

53. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False

54. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False
Correct!
The informed consent protects
the patient‘s right for
information and ensures the
consent to the trial.

55. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally given the consent to take part.
True False
Incorrect!
The informed consent protects the
patient‘s right for information and
ensures the consent to the trial.

56. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
When you are partecipating to a
study, you will be countinuosly
updated with all the relevant
information about the trial which may
influence your decision to remain in
the trial.
The informed consent does not
obligate you to remain in the trial by
any means.
You can leave the clinical trial at any
time without giving any explanation!

57. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False

58. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False
Correct!
Participation is voluntary and
can be quit at any time.

59. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False
Incorrect!
Despite a signed informed
consent, it is possible to quit a
clinical trial at any time.

60. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Informed Consent
You should ask any questions or
doubs you might have about the
clinical trial to the study team.
It is essential that you understand the
key statements in the informed
consent about the treatment, benefits
and risks.

61. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
What Protection Do You
Have as a Participant in a
Clinical Trial?

62. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Basic ethical principles and legal
codes which rule the medical
practice are also valid for clinical
trials!
In addition clinical trials are
governed through further
international guidelines and UK
legislations to protect participants
and to ensure their safety.

63. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Every clinical trial is checked for
patients safety and scientific
contents by an ethics committee
and the competent authority before
it can start.
Every good study undergoes strict
quality controls by the competent
research body.

64. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
Results from progressing clinical
trials are published on scientific
conferences, in journals and
reported to the authorities.
The names of the participants are
subject to data privacy. It is not
allowed to publish names of study
participants.

65. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False

66. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False
Incorrect!
The names of study
participants cannot be
revealed for privacy reasons.

67. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Patient Safety
It is standard that names of clinical trial
participants are kept secret.
True False
Correct!
It is standard in clinical trials that
names of participants are subject
of data privacy.

68. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Where Can I Find Clinical
Trials?
-Trials Register –
change on the right!

69. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Trials Register
If you are looking for a particular clinical trial you can
directly ask your doctor.
In addition you can search the website of the
National Health Service for relevant trials
http://www.nhs.uk/Conditions/Clinical-
trials/Pages/clinical-trial.aspx/
or the website of the ISRCTN
http://www.controlled-trials.com/ukctr/

70. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Trials Register
Registers contain public information
about recruiting and running studies,
about the place, the aim of the
study, its design and the information
about patients‘ selection criteria.
The trials register should also
contain contact information for
patients interested in partecipating.

71. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary

72. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
A clinical trial is a research study
conducted in oreder to test new
treatments on patients.
Clinical trials have precise and well
defined aims whose details are
detscribed by the study plan (protocol).

73. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
Clinical Trials are the fastest and
safest way to make new treatments,
which are better than the standard
ones, available to the public.
Clinical studies must be approved by
ethics committee and competent
authorities which review the study plan
and give their authorization.

74. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
Participating to clinical trials is always
voluntary.
You can quit a clinical trial at any time
– despite having signed the informed
consent.
Your personal rights and data are
protected.

75. Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights and
Protection
Study Register
Summary
Summary
We hope you liked this short tutorial and
found it useful. Keep exploring the
ECRAN website and learn even more
about clinical trials!
Thank you for your kind attention!