Introduction Clinical trials Why clinical trials? The Clinical Trial Process Informed consent Patients‘ interests Rights and protection Trial Registers.

Introduction

Clinical trials

Why clinical trials?

The Clinical Trial Process

Informed consent

Patients‘interests

Rights and protection

Trial Registers

Summary

Introduction

Clinical trials

Introduction

Clinical trials



Informed consent



Trial Registers

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.

Introduction

Clinical trials



Informed consent



Trial Registers

Summary

Introduction

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

Introduction

Clinical trials



Informed consent



Trial Registers

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

Introduction

Clinical trials



Informed consent



Trial Registers

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.

Introduction

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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!

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!

Introduction

Clinical trials



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Summary

What are clinical trials?

Introduction

Clinical trials



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Summary


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.

Introduction

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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.

Introduction

Clinical trials



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Summary


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.

Introduction

Clinical trials



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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.

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Clinical trials



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Summary


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.

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Clinical trials conducted on large number of patients are essential for proving the safety and the efficacy of a new treatment.

True False

Introduction

Clinical trials



Informed consent



Trial Registers

Summary



True False

Your choice is correct!

Introduction

Clinical trials



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Summary



True False

Your choice is

not correct!

Introduction

Clinical trials



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Summary


New treatments that have been tested in a laboratory have no risks whatsoever when used in clinical trials.

True False

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Clinical trials



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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.

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Clinical trials



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Summary


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.

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Why are clinical trials important?

Introduction

Clinical trials



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Summary


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.

Introduction

Clinical trials



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Summary


Clinical trials aim to enhance new or existing treatment and diagnostic strategies

Introduction

Clinical trials



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

Introduction

Clinical trials



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Summary

Are you considering enrolling in a clinical

trial?

Introduction

Clinical trials



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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.

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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!).

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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.

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

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Clinical trials‘ results always represent an improvement of the standard available treatment.

True False

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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.

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True False

Yes!But new interventions are only very slightly more likely than not to prove

better than standard treatments.

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Researchers conducting an ethical clinical trial hope that their new treatment will prove to be superior to standard treatments already available.

True False

Introduction

Clinical trials



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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

Introduction

Clinical trials



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Summary


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

Introduction

Clinical trials



Informed consent



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Summary

The clinical trial process

Introduction

Clinical trials



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Summary


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.

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Summary


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.

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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.

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Summary


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.

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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.

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Summary


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.

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Summary


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.

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Clinical trials firstly consider patients‘ safety and well being when testing a new treatment.

True False

Introduction

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True False

Correct!

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True False

Incorrect! Clinical trials are firstly committed

to patients‘ safety and only in second instance to scientific

results.

Introduction

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The control group always receives the less effective treatment.

True False

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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.

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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.

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Clinical trials



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Summary


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.

Introduction

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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.

Introduction

Clinical trials



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Summary

Informed consent

Introduction

Clinical trials



Informed consent



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Summary

Informed consent

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

Introduction

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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.

Introduction

Clinical trials



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Summary

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.

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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

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Informed consent


True False

Correct! The informed consent protects

the patient‘s right for information and ensures the consent to the clinical trial.

Introduction

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Informed consent


True False

Incorrect! The informed consent protects the patient‘s right for information and ensures the consent to the clinical

trial.

Introduction

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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!

Introduction

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Informed Consent

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

True False

Introduction

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Informed consent


True False

Correct!Participation is voluntary and

can be quit at any time.

Introduction

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Informed consent


True False

Incorrect!Despite a signed informed

consent, it is possible to quit a clinical trial at any time.

Introduction

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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.

Introduction

Clinical trials



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Summary

What protection do you have as a participant in

a clinical trial?

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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.

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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.

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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.

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Patient Safety

It is standard practice to keep secret the names of clinical trial participants.

True False

Introduction

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Patient safety


True False

Incorrect! The names of trial participants cannot be revealed for privacy

reasons plus similar amendments throughout! .

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Patient safety


True False

Correct! It is standard in clinical trials that names of participants are subject

of data privacy.

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Where can I find clinical trials?

-Trials Register -

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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 http://www.who.int/ictrp/en/U.S. National Services 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 services, e.g., for UK the National Health Servicehttp://www.nhs.uk/Conditions/Clinical-trials/Pages/clinical-trialaspx/

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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.

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Summary

Introduction

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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.

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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.

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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.

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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!

Introduction Clinical trials Why clinical trials? The Clinical Trial Process Informed consent Patients‘ interests Rights and protection Trial Registers.

Documents

development of new treatments

word treatment

surgical procedure

lifestyle changes diet

terms of effectiveness

existing therapies

opportune difference

best way