Addendum 3

Siopel guidelines for International Trials conduct  v. 5.0 – 22.01.2008

The following relates to the conduct of SIOPEL international trials. 

Definitions:

  • International Trial Chair (ITC) – the lead clinician responsible for the conduct of the trial.
  • International Vice-Chair (IVC) – the deputy of the lead clinician responsible for the conduct of the trial.
  • Chief Investigator (CI) - clinician responsible for the opening and running the trial in a given region or country.
  • Principal Investigator (PI) – clinician responsible for the opening and running the trial in a center.
  • Investigator - Any clinician or non-clinical researcher responsible for carrying out trial-related procedures according to the study protocol.
  • Internal Trial Consultation Service – electronic consultation service for patients registered in the trial in case of requests by local centers or by the ITC.
  • SAE – Serious Adverse Event.
  • SUSAR - Suspected Unexpected Serious Adverse Reactions.

1. Introduction:

SIOPEL Council is responsible for initiating new trials, in collaboration with members of the Discipline Panels.

2. Trial Committee Composition - General:

  • Membership of each SIOPEL trial committee should normally consist of at least two paediatric oncologists and include representation from the pathology, surgery and radiology groups, and eventually one or more radiotherapeutists, if considered appropriate.
  • Membership of the discipline panels (surgery, radiotherapy, pathology, radiology) is open to all members of the relevant discipline according to the SIOPEL statute.
  • International Trial Chairs (ITCs) of given trials are free to recommend the co-option of additional members with particular expertise, if appropriate, which should be ultimately approved by the SIOPEL Council. Where appropriate international vice-chairs (IVCs) will also be appointed to share the tasks of the ITCs.
  • The relevant International Trial Chair and Chief Trial Statistician are expected to attend meetings and conference calls which apply to issues of given trials.

3. Committee Membership:

General:

  • All nominations for new committee members must be submitted for approval by the International Trial Chair (ITC) to the SIOPEL Council. 
  • In considering trial committee membership, consideration should be given to achieving a balance between members of varying seniority, ensuring a spread of representation between centres, and giving younger members an opportunity to extend their experience.
  • Members will normally remain part of a committee long enough to allow them to be involved in the design and implementation of at least one study.
  • Membership of all individuals within a trial committee should be reviewed after 5 years and a recommendation made about continuing membership.  
  • Individuals must actively participate in the trial committee activities and are expected to ensure that they attend at least fifty percent of meetings and telephone conferences held each year.  Membership of those unable or unwilling to participate on this basis must be reviewed by the ITC and appropriate recommendations made.
  • Trial PIs should continue to carry responsibility for a trial until it is closed and the data are reported.  If a International Trial Chair  leaves the Group after a trial has closed but before follow up is completed or the results reported, they are still liable to write up the study.  If they relinquish this responsibility, the SIOPEL Council must designate a new International Trial Chair.

4. International Trial Chair– ITC -(Trial Chair):

  • The International Trial Chair is responsible to the SIOPEL Council for the activities of the committee.
  • The ITC should be appointed from amongst the existing members of the SIOPEL group.
  • A new ITC should be identified and appointed as ‘chair elect’ at least one year before the retirement of the existing Chair. 
  • The nomination for Chair-elect, which should have the support of all members of the trial committee, should be submitted to the SIOPEL Council for approval.  In the event of there being more than one potential candidate, a ballot of all Committee members should be held.  Any difficulty in identifying a successor should be referred to the SIOPEL Chairperson.
  • The retiring ITC may remain a member of the group and may continue to act as a Trial Chair but continuing membership beyond a further period of five years would be subject to the usual review.
  • One individual should not normally chair two working groups at the same time, although it is accepted that this may happen at a time of hand over.
  • The ITC is responsible for producing an annual report on the trial progress for the SIOPEL Council to be presented during spring group meeting.
  • The ITC should monitor attendance at the trial committee meetings.
  • The ITCs and IVCs are encouraged to report to the Council eventual difficulties in fulfilling obligations in order to seek every possible support.  The Council has the authority to replace the ITC and/or IVC, if he/she is not fulfilling their responsibilities.

5. Study stopping / suspending / major amendment:

  • In case the trial has to be suspended, stopped or amended substantially for whatever reason (i.e. when a stopping rule is reached) a detailed report has to be prepared by the International Trial Chair  in cooperation with the Trial Chief Statistician within a reasonable amount of time (generally within one month, in case of safety concerns within one week).
  • The report has to be circulated among the Trial Committee members for discussion and exchange of opinions. A common decision should be reached by an agreement and approved by the ITC.
  • The final report is submitted to the Independent Data Monitoring Committee for evaluation and advice.
  • Once a suggestion from IDMC is returned the International Trial Chair  contacts the SIOPEL Council in order to approve finally the decision on the study major amendment, suspension or closure.

6. Trial Committee Meetings:

  • It is expected that Trial Committees will normally meet on at least two occasions during the year.  The ITC is responsible for co-ordinating the arrangements for the meeting and should ensure that a record of the proceedings is produced and circulated to working group members.
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  • The agenda for each meeting should include a review of progress with recruitment in an open trial, and of the state of analysis and publication for closed trial, as well as forward planning for the new trial.
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  • Trial Committees should consider the frequent use of conference calls and/or web meetings, particularly when a full working group discussion is not required.  Arrangements for these can be made by the SIOPEL Data Centre.