Controlled clinical trials are the best way to test new treatments and assess their efficacy and safety compared to existing treatments or no treatment. Clinical trials follow strict protocols to assign patients randomly to treatment groups, protect patient safety, obtain informed consent, and keep participant identities confidential. Registers of clinical trials are available online to help patients find trials that may suit their medical needs and preferences.

2. Introduction
Clinical trials

3. Introduction
Controlled clinical trials are the best
way to test whether a treatment is
better than other treatments (or no
treatment).
Interventions for preventing or
treating health problems are
examined in a safe and efficient way.

4. Introduction
As a patient, you might be
considering enrolling in a clinical
trial or you might be invited to by
your physician.
If you are interested in the
evaluation of existing and new
treatments, you can also be
proactive and increase your
knowledge about clinical trials by
yourself.

5. Introduction
This tutorial will familiarize you
with the most important facts
about clinical trials.
We hope it will answer many of
the questions you may have
about them.

6. Introduction
Let‘s agree on words!
The process we are going to describe is
typical of new drug development, but also
applies to any other type of intervention,
such as diagnostic strategies, surgical
procedures, lifestyle changes (diet,
exercise, etc.) or comparisons between
new and existing therapies in terms of
effectiveness and safety.
To make things easier, we will use the
word “treatment” to refer to any type of
intervention.

7. What are controlled
clinical trials?

8. What are clinical trials?
Controlled clinical trials aim to
improve existing treatments or to
replace them with new and better
ones.
Before a new treatment is made
available for patients, it must be
tested in controlled clinical trials
for efficacy and safety.

9. What are clinical trials?
Controlled clinical trials are
designed to help us learn
more about the positive and
negative effects of treatments.
A treatment‘s efficacy and
safety can only be fully
assessed after long-term use
on patients in everyday clinical
practice.

10. What are clinical trials?
Before new drug treatments
are tested in patients in clinical
trials they must be carefully
evaluated in laboratories.
If the results of laboratory
studies of a possible treatment
are promising, clinical trials
are designed to assess its
possible beneficial and
adverse effects in patients

11. What are clinical trials?
New treatments need to be
evaluated statistically in clinical
trials involving large numbers of
similar patients.
Results must be reviewed
systematically and carefully
analysed.

12. What are clinical trials?
Controlled clinical trials conducted
on large numbers of patients are
essential for assessing the efficacy
and safety of new treatments.
True False

13. What are clinical trials?
Controlled clinical trials conducted
on large numbers of patients are
essential for assessing the efficacy
and safety of new treatments.
True False
Your choice is
correct!

14. What are clinical trials?
Controlled clinical trials conducted
on large numbers of patients are
essential for assessing the efficacy
and safety of new treatments.
True False
Your choice is
not correct!

15. 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. What are clinical trials?
New treatments that have
been tested in a laboratory
have no risks whatsoever
when used in clinical trials.
True False
Correct! Laboratory tests help
designing new treatments but cannot
reveal risks for patients.

17. What are clinical trials?
New treatments that have
been tested in a laboratory
have no risks whatsoever
when used in clinical trials.
True False
Wrong!
New treatments can always
have unknown and
unpredictable risks.

18. Why are controlled
clinical trials
important?

19. Why are clinical trials important?
Controlled clinical trials help to
develop new and better
treatments for patients.
Assessing efficacy and safety of
a new treatment is a very
rigorous and often long process.
For this reason, new treatments
usually take a lot of time before
becoming publicly available.

20. Why are clinical trials important?
Clinical trials aim to enhance new
or existing treatments and
diagnostic strategies.

21. Why are clinical trials important?
Clinical trials are important because
they investigate and compare new
and existing treatments, thus
promoting progress in treatment.

22. Are you considering
enrolling in a clinical
trial?

23. 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. Enrolling in a clinical trial?
To avoid disappointment you
should remember that new
treatments are almost as likely to
be worse as to be better than
standard treatments. Indeed,
that‘s why controlled clinical
trials are needed!

25. Enrolling in a clinical trial?
Patients should consider
participating in a clinical trial if there
is a good chance that they will
benefit from the new treatment.
Controlled clinical trials provide an
opportunity for them to receive new,
experimental treatments that are
not yet generally available. This is
especially true for diseases with no
known cure.

26. Enrolling in a clinical trial?
Clinical trial participants also
often wish to contribute to
research to help other patients
by participating in clinical trials.

27. Enrolling in a clinical trial?
The results of clinical trials always
represent an improvement of the
standard available treatment.
True False

28. Enrolling in a clinical trial?
The results of clinical trials always
represent an improvement of the
standard available treatment.
True False
No!
Even if many clinical trials result in an
improvement there is no guarantee of this.
A new treatment could be as good as or
even worse the standard treatment.

29. Enrolling in a clinical trial?
The results of clinical trials always
represent an improvement of the
standard available treatment.
True False
Yes!
But new interventions are only very slightly
more likely than not to prove better than
standard treatments.

30. Enrolling in a clinical trial?
Researchers conducting an ethical clinical
trial hope that their new treatment will
prove to be superior to standard
treatments already available.
True False

31. Enrolling in a clinical trial?
Researchers conducting a clinical trial
hope that their new treatment is better
than the standard one already available.
True False
Your choice is not correct!
Reseachers always conduct a
clinical trial in the hope of
improving treatment

32. Enrolling in a clinical trial?
Researchers conducting a clinical trial
hope that their new treatment is better
than the standard one already available.
True False
Correct!
Although disappointment is possible,
researchers always hope to achieve an
improvement

33. The clinical trial
process

34. The clinical trial process
Every clinical trial is designed to
answer questions about the effects
of treatments being compared.
The quality of a clinical trial and its
results depend heavily on a well
chosen question, building on
existing evidence, and on good
clinical trial design.

35. The clinical trial process
When conducting a clinical trial,
researchers must follow a written
study plan, also called a study
protocol.
The protocol helps to ensure patients‘
safety and is essential for achieving
high quality and reliable results.

36. The clinical trial process
Some clinical trials are conducted
on one group of patients only, whilst
most compare two groups.
Patients in different comparison
groups must be as similar as
possible e.g. they must have the
same medical conditions, at the
same stage of a disease.

37. The clinical trial process
Patients are assigned to one group or
another (for example, to receive a new
treatment or a standard one) by a
method called randomisation, or
random allocation/assignment. Chance
(using a random number generator or
some equivalent) is used to decide the
allocation sequence/plan.
This type of clinical trial is called a
randomized trial.

38. The clinical trial process
Sometimes, one group in a 2-group
randomized trial is referred to as ‘the
experimental group’ or ‘the active
group’, and the comparison group is
called ‘the control group’.

39. The clinical trial process
The control group in a clinical trial is
treated with the same care as the active
group.
If possible, neither the researchers nor the
patients should know to which group every
participant has been assigned.
This special type of clinical trial is called a
blinded or masked trial and it helps to
ensure comparability between the
comparison groups when treatment
outcomes are assessed.

40. The clinical trial process
For some diseases there are no
standard treatments available. And
in this situation the control group
receives a dummy treatment called
a placebo, such as a sugar pill.
Important For ethical reasons,
placebo control groups are not
allowed if an effective treatment
already exists and patients can
benefit from it. In these
circumstances, patient allocated to
the control group should receive the
best standard treatment.available.

41. The clinical trial process
When testing a new treatment, controlled
clinical trials must give priority to protecting
patients‘ safety and wellbeing.
True False

42. The clinical trial process
When testing a new treatment, controlled
clinical trials must give priority to protecting
patients‘ safety and wellbeing.
True False
Correct!

43. The clinical trial process
When testing a new treatment, controlled
clinical trials must give priority to protecting
patients‘ safety and wellbeing.
True False
Incorrect!
Clinical trials are first and foremost
committed to patients‘ safety and
only secondarily to scientific
results.

44. The clinical trial process
The control group always receives the
less effective treatment.
True False

45. 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 know which treatment
will be better - standard or new.
Both treatments could be equally
helpful for patients.

46. The clinical trial process
The control group always receives the
less effective treatment.
True False
Correct!
When starting a clinical trial, there is
uncertainty about whether the standard
therapy or the new treatment will turn
out to be better. And both treatments
could be equally good.

47. The clinical trial process
For ethical reasons, if during a clinical
trial one treatment is clearly shown to
be superior to the comparison
treatment, the independent data
monitoring and safety committee will
recommend that the trial be stopped.
The better treatment is then offered to
patients with the health problem in
question.

48. The clinical trial process
Patients should only enroll in a clinical
trial after having clearly understood
the benefits and adverse effects they
might experience.
It is essential that patients are given
clear information before deciding
whether to participate.

49. Informed consent

50. Informed consent
Informed consent should give you all
the important information about the
clinical trial to help you decide
whether to enroll.

51. Informed consent
As a first step, every potential
participant meets one of the clinical trial
researchers, who will explain the
possible benefits and risks of
participating.

52. Informed consent
After the meeting, the researcher will
give you detailed written information
about the clinical trial to help you
consider whether to participate.
If you decide to enroll in the study,
you will be asked to sign and date an
informed consent declaration.
You always have the right to decline
an invitation to take part in a clinical
trial.

53. Informed consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally consented to take part.
True False

54. Informed consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally consented to take part.
True False
Correct!
The consent process protects the
patient‘s right to receive information
and ensures the informed consent
to participate in a clinical trial.

55. Informed consent
Informed consent ensures that nobody
enrolls in a clinical trial without having
received detailed information and having
personally consented to take part.
True False
Incorrect!
The consent process protects the
patient‘s right to receive information
and ensures the informed consent to
participate in a clinical trial.

56. Informed Consent
When you are participating in a
clinical trial, you will be updated
periodically with relevant information
which could influence your decision
to remain in the trial.
Informed consent does not obligate
you to remain in the clinical trial. You
can leave the clinical trial at any time
without giving any explanation!

57. Informed Consent
Once a participant has signed the
informed consent form, it is not possible
to leave the clinical trial anymore.
True False

58. 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 you
can quit at any time.

59. 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 signed informed consent,
you can quit a clinical trial at any
time.

60. Informed consent
You should ask the study team any
questions or doubts you may have
about the clinical trial.
It is essential that you understand
the key statements in the informed
consent document about the
treatments and their possible
benefits and risks.

61. What protection do you
have as a participant in
a clinical trial?

62. Patient safety
The basic ethical principles and
legal codes which govern medical
practice also apply to treatments
given in clinical trials!
In addition, to protect trial
participants, clinical trials are
governed through further
international guidelines and
legislation.

63. Patient safety
Before a clinical trial can start, it is
checked for patient safety and
scientific content by an ethics
committee and (for drug trials)
other competent authorities.
All good studies undergo strict
quality control.

64. Patient safety
Results from clinical trials should
be made public at scientific
conferences and in journals, and
reported to relevant authorities.
The identity of trial participants
remains confidential.

65. Patient Safety
It is standard practice to keep the
names of clinical trial participants
secret.
True False

66. Patient safety
It is standard practice to keep the
names of clinical trial participants
secret.
True False
Incorrect!
The names of trial participants
must not be revealed! .

67. Patient safety
It is standard practice to keep the
names of clinical trial participants
secret.
True False
Correct!
It is standard practice in clinical
trials that names of participants
will not be disclosed.

68. Where can I find clinical
trials?
-Trials Registers -

69. Trials Registers
If you are looking for a particular clinical trial you can
ask your doctor.
In addition you can search the following websites:
WHO International Clinical Trials Registry Platform at
http://www.who.int/ictrp/en/
US National Institutes of Health at
http://clinicaltrials.gov/
The ISRCTN at http://www.controlled-
trials.com/ukctr/
The EU Clinical Trials Register at
www.clinicaltrialsregister.eu
The website of your national health service, e.g., the
UK National Health Service
http://www.nhs.uk/Conditions/Clinical-
trials/Pages/clinical-trialaspx/

70. Trials Registers
Registers contain public information
about clinical trials, such as venues,
aims, designs and patient selection
criteria.
Trial registers should also contain
contact information for patients
interested in participating.

71. Summary

72. Summary
A controlled clinical trial is conducted to
test new or existing treatments on
patients.
Clinical trials should have well defined
aims and methods, which are described
in detail in trial protocols.

73. Summary
Controlled clinical trials are the most
reliable and safest way to assess
whether new treatments are better
than standard treatments.
Proposals for clinical trials must be
assessed and authorised by ethics
committees and other competent
authorities.

74. Summary
Participating in clinical trials is always
voluntary.
You can quit a clinical trial at any time
– despite having signed an informed
consent document.
Your personal rights and data are
protected.

75. 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!