1. Clinical trials
Introduction

2. 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 are the fastest and safest way to find and evaluates new treatments.

4. 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 new treatments, you can also be proactive and increase your knowledge about clinical trials by yourself.

5. 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 Let‘s agree on words!
The process we are going to describe is more typical of new drugs development, but also applies to any other type of intervention, such as diagnostic or surgical procedure, lifestyle changes (diet, exercise, etc.) or comparison between new and existing therapies in terms of effectiveness and safety (with the opportune difference when discussing doses, placebo, etc which may not be pertinent).
From now on we will use the word “treatment” for making things easier!

7. What are clinical trials?

8. What are clinical trials?
Clinical trials aims 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 a clinical trial for safety and efficacy.

9. 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.

10. What are clinical trials?
Before being tested on patients in a clinical trial, new treatments must be carefully evaluated in the laboratory.
If the results of laboratory studies of a possible treatment are promising, clinical trials can be designed to assess its effects in patients.

11. 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.
In fact, clinical trials aim to assess not only treatments‘ efficacy but also all the possible risks.

12. What are clinical trials?
New treatments 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.

13. What are clinical trials?
Clinical trials conducted on large number of patients are essential for proving the safety and the efficacy of a new treatment.
True
False

14. What are clinical trials?
Clinical trials conducted on large number of patients are essential for proving the safety and the efficacy of a new treatment.
True
False
Your choice is correct!

15. What are clinical trials?
Clinical trials conducted on large number of patients are essential for proving the safety and the efficacy of a new treatment.
True
False
Your choice is
not correct!

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

17. What are clinical trials?
If a new treatment has been previously tested in laboratory, there is no risk whatsoever when used in clinical trials.
True
False
Correct! Laboratory tests help designing new treatments but cannot reveal risks for patients.

18. 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.

19. Why are clinical trials important?

20. Why are clinical trials important?
Clinical trials help developing new and better treatments for patients.
Assessing safety and efficacy of a new treatment is a very rigorous and long process. For this reason, new treatments usually take a lot of time before becoming available for the public.

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

22. Why are clinical trials important?
Clinical trials are important because they investigate and compare new and already existing treatments, therefore enhancing the medical progress.

23. Are you considering enrolling in a clinical trial?

24. Enrolling in Clinical Trials?
Patients enroll in clinical trials for several reasons.
Many people hope to benefit from having access to a new treatment.

25. 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!).

26. 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 new and experimental treatments not yet available on the market.This is especially true for diseases with no-known cure.

27. Enrolling in a clinical trial?
Some other participants wish to contribute to research in medicine and to help other patients by voluntarily participating to a clinical trial.

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

29. Enrolling in a 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 there is no guarantee for success.
A new treatment could be as good as or even worse the standard treatment.

30. Enrolling in a clinical trial?
Clinical trials‘ results 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.

31. 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

32. Your choice is not correct!
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 to improve a treatment

33. 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 intend to achieve an improvement

34. The clinical trial process

35. 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 depend on a well chosen clinical trial design.

36. The clinical trial process
When conducting a clinical trial, researchers must always follow a written study plan also called study protocol.
The protocol both ensures patients‘ safety and is essential for achieving high quality and reliable results.

37. 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 stage of the disease.

38. 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.
This type of clinical trial is called randomized trial.

39. The clinical trial process
When the study is conducted on two groups of patients, the first group is called “controI group“ and often receive the standard available treatment, while the other one is called “active group“ and is given the new treatment.
This type of clinical trial is called controlled trial.

40. 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 which group every participant has been assigned.
This special type of randomised trial is called blinded or masked randomised trial and ensure equal treatments for both groups.

41. The clinical trial process
For many diseases there are no standard treatments available yet. In this case the control group receives 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. Therefore the best standard available treatment must be used.

42. The clinical trial process
Clinical trials firstly consider patients‘ safety and well being when testing a new treatment.
True
False

43. The clinical trial process
Clinical trials firstly consider patients‘ safety and well being when testing a new treatment.
True
False
Correct!

44. 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 committed to patients‘ safety and only in second instance to scientific results.

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

46. 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.

47. 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.

48. 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 disease in question.

49. 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 take.
It is therefore essential that patients are given clear and exhaustive information before they agree to participate.

50. Informed consent

51. Informed consent
The informed consent gives you all the important information about any aspects of the clinical trial before deciding to enroll.

52. 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.

53. Informed consent
After the meeting, the researcher will hand you out detailed information about the clinical trial in written form, because you should carefully think about a participation.
If you decide 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 clinical trial.

54. 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

55. 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 clinical trial.

56. 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 clinical trial.

57. Informed Consent
When you are participating in a clinical trial, you will be continuosly updated with all the relevant information which may influence your decision to remain in the trial.
The informed consent does not obligate you to remain in the clinical trial by any means.
You can leave the clinical trial at any time without giving any explanation!

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

59. Participation is voluntary and can be quit at any time.
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.

60. 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.

61. Informed consent
You should ask any questions or express doubts 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.

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

63. 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 legislations to protect participants and to ensure their safety.

64. 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.

65. 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.

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

67. Patient safety
It is standard practice to keep secret the names of clinical trial participants.
True
False
Incorrect!
The names of trial participants cannot be revealed for privacy reasons plus similar amendments throughout! .

68. Patient safety
It is standard practice to keep secret the names of clinical trial participants.
True
False
Correct!
It is standard in clinical trials that names of participants are subject of data privacy.

69. Where can I find clinical trials?
Trials Register -

70. Trials Register
If you are looking for a particular clinical trial you can directly ask your doctor.
In addition you can search the following websites:
WHO International Clinical Trials Registery Platform at
U.S. National Services of Health at
The ISRCTN at
The EU Clinical Trials Register at
The website of your national health services, e.g., for UK the National Health Service

71. Trials Register
Registers contain public information about clinical trials such as venues, aims, designs and patients‘ selection criteria.
The trials registers should also contain contact information for patients interested in participating.

72. Summary

73. Summary
A clinical trial is conducted to test new or existing treatments on patients.
Clinical trials should have precise and well defined aims which are described in detail in the trial protocol.

74. Summary
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.

75. 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.

76. 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!