Clinical trials - ECRAN Project

Introduction

Clinical Trials

Why Clinical Trials?

Process of Clinical Trial

Informed Consent

Patients‘Interests

Rights and Protection

Study Register

Summary

Introduction

Clinical Trials

Introduction

Clinical Trials



Informed Consent



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.

Introduction

Clinical Trials



Informed Consent



Study Register

Summary

Introduction

Clinical studies are the fastest and safest way to find innovative therapies and new effective treatments.

Introduction

Clinical Trials



Informed Consent



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.

Introduction

Clinical Trials



Informed Consent



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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

Clinical Trials



Informed Consent



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Summary

What are Clinical Trials?

Introduction

Clinical Trials



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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.

Introduction

Clinical Trials



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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



Informed Consent



Study Register

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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.

Introduction

Clinical Trials



Informed Consent



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Summary


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.

Introduction

Clinical Trials



Informed Consent



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Summary


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.

Introduction

Clinical Trials



Informed Consent



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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

Introduction

Clinical Trials



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True False

Your choice is correct!

Introduction

Clinical Trials



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True False

Your choice is

not correct!

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Clinical Trials



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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 risks 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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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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Clinical Trials



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Why are Clinical Trials Important?

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Clinical Trials



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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.

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Clinical Trials



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Clinical trials aim to enhance new or already existing treatment strategies or to check out new therapeutic/diagnostic methods.

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Clinical Trials



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Clinical trials also important because they investigate the causes of diseases and their findings are essential for enhancing the medical progress.

Introduction

Clinical Trials



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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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Clinical Trials



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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!).

Introduction

Clinical Trials



Informed Consent



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

Introduction

Clinical Trials



Informed Consent



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Summary


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

Introduction

Clinical Trials



Informed Consent



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

True False

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Clinical Trials



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Enrolling in Clinical Trial?


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.

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True False

Yes!Most but NOT all of the treatments have turned out to be better than

the standard treatment.

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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

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Clinical Trials



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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.

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Clinical Trials



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True False

Correct! Although disappointment is possible, researchers always intend to achieve

an improved or at least an equally good treatment.

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Clinical Trials



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The Clinical Trial Process

(change on the right!)

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Clinical Trials



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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.

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Clinical Trials



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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.

Introduction

Clinical Trials



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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 stadium of the disease.

Introduction

Clinical Trials



Informed Consent



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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.

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Clinical Trials



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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.

Introduction

Clinical Trials



Informed Consent



Study Register

Summary


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.

Introduction

Clinical Trials



Informed Consent



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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!

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Clinical Trials



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

True False

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True False

Correct!

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True False

Incorrect! Clinical trials are firstly commited

to patients‘ safety and only in second instance to scientific

results.

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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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Clinical Trials



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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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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.

Introduction

Clinical Trials



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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 incur in.

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

Introduction

Clinical Trials



Informed Consent



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Informed Consent

Introduction

Clinical Trials



Informed Consent



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Informed Consent

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

Introduction

Clinical Trials



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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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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.

Introduction

Clinical Trials



Informed Consent



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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 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 trial.

Introduction

Clinical Trials



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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!

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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

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Informed Consent


True False

Correct!Participation is voluntary and

can be quit at any time.

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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.

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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.

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Clinical Trials



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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 UK legislations to protect participants and to ensure their safety.

Introduction

Clinical Trials



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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.

Introduction

Clinical Trials



Informed Consent



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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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Clinical Trials



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Patient Safety

It is standard that names of clinical trial participants are kept secret.

True False

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Patient Safety


True False

Incorrect! The names of study

participants cannot be revealed for privacy reasons.

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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 –

change on the right!

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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 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/

Introduction

Clinical Trials



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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.

Introduction

Clinical Trials



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Summary

Introduction

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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).

Introduction

Clinical Trials



Informed Consent



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.

Introduction

Clinical Trials



Informed Consent



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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!

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Clinical trials - ECRAN Project