Clinical Trials in Finland

1
Clinical Trials in Finland

• Management of Clinical Trials in Finland
• Päivi Itkonen
• Crown CRO Oy
• 27.1.2009

2
Contents

• Ethics Committees
• Preliminary announcement
• Application for the EC opinion
• EC submission package
• Authorization of Clinical Trial in hospitals

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Ethics Committees

• .

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Ethics Committees

• National Advisory Board on Health Care Ethics
  (ETENE) www.etene.org
• Sub-Committee on Medical Research Ethics (TUKIJA)
  www.etene.org/tukija
• Ethics Committees of Hospital Districts

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The National Advisory Board on Health Care Ethics
(ETENE)

• Established on 1.4.1998 under the Act on the
  Status and Rights of Patients
• Deals with ethical issues related to health care
  and the status and rights of patients from the
  point of view of principle
• Can take initiatives and issue advisory opinions
  and recommendations on ethical health care issues
• Provides expert assistance with the development
  of health care and relevant legislation
• Collects and distributes information on ethical
  questions evolved in health care

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Sub-Committee on Medical Research Ethics (TUKIJA)

• Appointed on 1.10.1999 by the National Advisory
  Board on Health Care Ethics
• Operations are based on Decree on ETENE and the
  Act on Medical Research
• Responsibilities
• Reviews and gives national opinion of
  international multi-centre clinical trials on
  medicinal products, unless TUKIJA has transferred
  the review to an ethics committee of a hospital
  district
• Gives opinion of re-submitted unchanged trial to
  ethics committees of hospital districts in cases
  where a prior negative opinion has been given
• Supports the ethics committees of the hospital
  districts in questions of principle, especially
  related to research ethics, and in training

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Hospital District Ethics Committees

• Responsibilities
• To give opinions of trials transferred to the
  ethics committee
• To give opinions of other medical studies
  relevant to its field of activities
• Where the ethics committee gives a negative
  opinion of a trial and the applicant resubmits an
  unchanged research proposal, the ethics committee
  shall apply for an opinion from TUKIJA
• After appropriate corrections an opinion can be
  given without TUKIJAs opinion

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Hospital District Ethics Committees

• 21 hospital districts
• Etelä-Karjala www.ekshp.fi
• Etelä-Pohjanmaa www.epshp.fi
• Etelä-Savo www.esshp.fi
• Helsinki/Uusimaa www.hus.fi (5 committees)
• Itä-Savo www.isshp.fi
• Kainuu www.kainuu.fi
• Kanta-Häme www.khshp.fi
• Keski-Pohjanmaa www.kpshp.fi
• Keski-Suomi www.ksshp.fi
• Kymenlaakso www.kymshp.fi
• Lappi www.lshp.fi
• Länsi-Pohja www.lpshp.fi
• Pirkanmaa www.pshp.fi
• Pohjois-Karjala www.pkssk.fi
• Pohjois-Pohjanmaa www.ppshp.fi
• Pohjois-Savo www.psshp.fi
• Päijät-Häme www.phsotey.fi
• Satakunta www satshp.fi

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Preliminary Announcement

• .

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Preliminary Announcement

• For all international multi-centre trials, the
  Sponsor shall apply for a decision from TUKIJA on
  whether TUKIJA is to evaluate the trial or
  wheather the review will be transferred to a
  relevant hospital district ethics committee
• This preliminary announcement should be made once
  it becomes probable that the trial will be
  conducted in Finland
• If the trial is transferred to a hospital
  district ethics committee, the EC is chosen from
  the region where the national coordinating
  investigator works
• For local and non-interventional studies
  preliminary announcement is not needed, the
  ethical review will be done at the hospital
  district ethics committee where the national
  coordinating investigator works

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Preliminary Announcement

• Information required on the form
• EudraCT number
• Protocol number
• Sponsor
• Contact person
• Phase
• Therapeutic area
• Vulnerable patient populations
• Date and signature

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Preliminary announcement

• The preliminary announcement is sent to the
  secretary of TUKIJA as an email attachment
  (etene_at_stm.fi) and by mail (cover letter not
  needed)
• The preliminary announcements to be submitted to
  TUKIJA at the latest on Monday of the week of the
  review meeting
• Review meetings at least every 2 weeks, meeting
  dates available www.etene.org
• The next deadlines 02 Feb, 16 Feb, 02 Mar, 16 Mar
  and 30 Mar 2009

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Application for the EC opinion

• .

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Application for the EC opinion

• The application shall be made using a form issued
  by the Ministry of Social Affairs and Health,
  irrespective of the reviewing EC
• The form and its attachments shall be submitted
  to the reviewing EC at least two weeks prior to
  the meeting where the review is considered to
  take place
• Deadlines on EC websites
• The opinion shall be given within 60 days of
  receipt of a valid application

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EC submission package

• .

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EC submission package

• The application to EC shall include the following
  documents
• Trial protocol (can be in English)
• Finnish summary of the trial
• Investigators Brochure (can be in English)
• Statement by the person in charge of the
  investigation on its conformity with research
  ethics especially regarding appropriateness of
  aims and planning and evaluation of risks and
  benefits
• Subject information
• Informed Consent Forms
• Information on how the consent will be obtained
• Rationale for the trial in cases where subjects
  who are not able to give their informed consent
  are included in the trial

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EC submission package

• 9. Information on detailed procedures for
  selection of subjects
• 10. Other material to be given to the subject
• 11. Description of the personal data file in
  accordance with the Personal Data Act
• included only in the EC submission package, is
  not sent to any registry
• 12. List of trial sites and investigators in
  Finland
• 13. Statement by the person in charge of the
  investigation on the quality of trial facilities
  and equipment of the trial sites
• 14. Statement on the suitability of the person in
  charge of the investigation and the responsible
  investigators at other trial sites
• 15. Trial fees and compensations
• 16. Insurance coverage for the subjects, unless
  patient insurance and medicines-related inquiries
  insurance cover the trial

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TUKIJAs register

• The register of TUKIJA is a public register and
  therefore no confidential information will be
  entered
• The following items will be registered
• TUKIJAs diary number of the research plan
• The code provided by the Sponsor
• The EudraCT number
• The Sponsor
• The contact person
• The arrival date of the trial application
• The Sponsor of the trial shall have a contact
  person in Finland for communication related to
  the application procedure

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EC opinion

• The EC shall give its opinion within 60 days of
  arrival of a valid application
• If the trial concerns drugs aimed at gene therapy
  or somatic cell treatment of drugs including
  genetically modified organisms, the deadline for
  giving the opinion is 90 days
• Can be prolonged by an additional 90 days if the
  evaluation requires extensive additional
  investigations
• An opinion related to xenogenic cell therapy is
  not bound to any timelines
• The EC may request additional information from an
  investigator or the sponsor of the trial only
  once
• Only one national EC opinion required

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Amendments

• EC will review amendments to trials whcih may be
  of significance with regard to the ethics review
• Influence on safety or physical or mental
  integrity of subjects
• Influence on scientific value and significance of
  the trial
• Influence on the conduct of the management of the
  trial
• Influence on the quality or safety of any
  investigational medicinal product used in the
  trial
• The application for review of an amendment shall
  include a summary of the main changes abd a
  statement by the national coordinating
  investigator concerning the impact of the
  amendment on the ethics of the trial
• EC shall give its opinion within 35 days of
  receipt of a valid application

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SUSARs

• TUKIJA shall be informed only of unexpected
  serious adverse reactions occurring in trials in
  Finland, which trials have been reviewed by
  TUKIJA
• A statement on the adverse reaction is not needed
• If the drug administration is blinded, the code
  does not need to be broken for the report
• The following reports do not need to be reported
  to TUKIJA
• Unexpected serious adverse reactions occurred in
  the trial site abroad
• Unexpected serious adverse reactions occurred in
  other trials
• Periodic reports on serious adverse reactions in
  all trial sites
• Serious unexpected spontaneous reports
• Reports based on literature
• An annual list of suspected serious adverse drug
  reactions from the trial
• A statement on the safety of the subjects is
  required
• Hospital District ECs may have different
  reporting rules

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Information on completion of the trial

• The EC needs to informed on the completion of
  clinical trials within 90 days of completion
• If the trial has been discontinued earlier, the
  report shall be made within 15 days
• The report shall include the reason for premature
  discontinuation
• A summary of the clinical trial report shall be
  provided to the ethics committee within a year of
  trial completion

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Fees

• Opinions are subject to a fee in accordance with
  the Decree of the Ministry of Social Affairs and
  Health on fees of charged for statements of the
  National Advisory Board on Health Care Ethics and
  the Sub-Committee an Medical Ethics and on
  remunerations payable to research subjects
• Current fees
• Multi-centre trial 1200 Eur
• One-site trial 1200 Eur
• Amendment 500 Eur

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Authorization of a clinical trial in hospitals

• Most of the hospitals require an authorization of
  a clinical trial before the trial start
• The following items are needed
• Application for the authorization of a clinical
  trial
• Subject information and consent form
• Protocol or its summary
• Positive opinion of the EC