Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights an...
Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights an...
Introduction
Clinical Trials
Why
Clinical Trials?
Process of
Clinical Trial
Informed Consent
Patients‘
Interests
Rights an...
Introduction
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Why
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Process of
Clinical Trial
Informed Consent
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Introduction
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Why
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Introduction
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Clinical trials - ECRAN Project

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Clinical trials - ECRAN Project

  1. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 49. Introduction Clinical Trials Why Clinical Trials? Process of Clinical Trial Informed Consent Patients‘ Interests Rights and Protection Study Register Summary Informed Consent
  50. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 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. 71. Introduction Clinical Trials Why Clinical Trials? Process of Clinical Trial Informed Consent Patients‘ Interests Rights and Protection Study Register Summary Summary
  72. 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. 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. 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. 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!
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