ࡱ> [ Zbjbj jjS2l " ...$RP<JRB_l"444!!!^^^^^^^$a c^.!E!@!!!^$..44^,$$$!.4.4^$!^$$?).1V..[Y4 ]nRl)$.X@[YD_<B_Y@dW$.d[Y$RR....ContentDETAILIntroductionName (and sponsors ID) of trial plus ISRCTN and/or EUDRACT numberMRC RE04: A Randomised Controlled Trial of Interferon-a, I nterleukin-2 and 5-Fluorouracil vs Interferona Alone in Patients with Advanced Renal Cell Carcinoma (ISRCTN 46518965)Objectives of trial, including interventions being investigatedThe trial objectives are to evaluate the value of triple combination therapy compared with IFN-a alone in patients with advanced metastatic renal cell carcinoma in terms of: 1) Overall survival 2) Progression-free survival time and toxicity 3) Quality of Life during therapy and follow-up 4) Health economic implications(see Figure 1).Outline of scope of charterThe purpose of this document is to describe the roles and responsibilities of the Data Monitoring Committee (DMC) for the MRC RE04 trial, including the timing of meetings, methods of providing information to and from the DMC, frequency and format of meetings, statistical issues and relationships with other committees.Roles and responsibilitiesA broad statement of the aims of the committeeTo safeguard the interests of trials participants, potential participants, investigators and sponsor; to assess the safety and efficacy of the trials interventions, and to monitor the trials overall conduct, and protect its validity and credibility. Terms of referenceThe DMC should receive and review the progress and accruing data of this trial and provide advice on the conduct of the trial to the TSC. Specific roles of DMCTo undertake interim review of the trials progress by: assessing data quality, including completeness (thereby encouraging collection of high quality data) monitoring recruitment figures and losses to follow-up monitoring compliance with the protocol by participants and investigators monitoring evidence for treatment differences in the main efficacy and safety outcome measures and thus recommending action when/whether the main trial question has been answered monitoring evidence for treatment harm e.g. toxicity, SAEs, deaths recommending whether the trial should continue to recruit or follow-up [see section on decision-making] recommending any major changes to the protocol, where necessary (e.g. changes to the recruitment procedures, inclusion criteria, endpoints, data collection, etc ) advising on and/or endorsing any major protocol modifications suggested by investigators or sponsors (e.g. changes to the inclusion criteria, endpoints, data collection, etc) monitoring planned sample size with regards (i) a priori assumptions about the control arm outcome and (ii) emerging differences in clinically relevant subgroups suggest additional data analyses assessing the impact and relevance of any external evidence provided monitoring compliance with previous DMC recommendations considering the ethical implications of any recommendations made by the DMC The DMC should not have a role in increasing or decreasing the planned sample size as it is not blind to the current results of the trial. (See decision-making)Before, or early in to, the trialWhether the DMC will have input into the protocolAll potential DMC members will have sight of the protocol/outline before agreeing to join the committee. Before recruitment begins the trial will have undergone peer review by the funding body, scrutiny by the TMG and TSC, internal review and will be approved by an MREC. Therefore, if a potential DMC member has major reservations about the trial they should report these to the CTU and may decide not to accept the invitation to join. DMC members should be independent and constructively critical of the ongoing trial, but also supportive of aims and methods of the trial.Whether the DMC will meet before the start of the trialThe DMC should meet early in to the trial, preferably in person. The timing should within one year of commencing accrual or before 10% of the planned events have been reported; whichever is sooner. The aim of the first meeting would be to discuss the working of the DMC. The first report should contain tables and graphs based on real data wherever possible. Consideration should be given to shell (empty) tables for the data not yet available. One aim of meeting is to familiarise the DMC members with the format that will be used in the reports and to give them the opportunity to suggest changes and additions.. Any specific regulatory issuesNone, the drug is already licensed appropriatelyWhether members of the DMC will have a contractFor trials run by the CTU CD, DMC members will agree to this document to register their assent. This can be in the form of a letter or email and should confirm (1) that they agree to be on the DMC and (2) that they agree with the contents of this Charter. There will be no formal contracts.Composition Membership and size of the DMC The membership will consist of 3 individuals that includes at least one clinician and at least one statistician. Members have been chosen because they are experienced in trials and/or the disease area. The members have been recommended by the TMG and approved by the TSC. The members should be independent of the trial (e.g. should not be involved with the trial in any other way or have some involvement that could impact on the trial). Members should not serve on DMCs of similar, concurrently active trials as this could compromise the independence of the trial and possibly the confidentiality of the results of the individual trials. Any competing interests, both real and potential, should be declared. A short competing interest form should be completed and returned by the DMC members (Appendix 1). Note: Competing interests is the preferred term over conflicts of interest because it avoids any implication of wrongdoing and may encourage greater co-operation in reporting interests (Reference: Br J Med). The members of the DMC for RE04 are: Dr Jonathon Joffe (Clinician), Huddersfield Prof. Mike Lind (Clinician), Hull Dr Keith Wheatley (Statistician), BirminghamThe chair, how they are chosen and the chairs role. (Likewise, if relevant, the vice-chairman)The TMG has nominated the chair which has been be approved by the TSC. The chair is Dr J Joffe, a clinician serving on the DMC. The Chair is expected to facilitate and summarise discussions. The responsibilities of the DMC statisticianThe DMC membership includes a statistician to provide independent statistical expertise and to further guide the other DMC members through the report. The DMC statistician is not expected to prepare the DMC report.The responsibilities of the trial statisticianThe trial statistician, Patrick Royston, is the main CTU representative. He is responsible for the production of the report to the DMC, will guide the DMC through the report, may participate in DMC discussions, will comment on minutes and may have to take notes on some occasions.The responsibilities of the CTU members of the trial teamThe other CTU members of the trial team (i.e.Tahera Hussein, Trial Manager; Tim Barlow, Data Manager) will input to the production of the DMC report, will help talk through the DMC report and will participate in some DMC discussions. FD: The trial manager may have to take notes on some occasions.The responsibilities of the PI and other members of the TMGThe PI, Martin Gore, may be asked and should be available to attend open sessions of the DMC meeting. The other TMG members will not usually be expected to attend but can attend open sessions when necessary (See Organisation of DMC Meetings).RelationshipsRelationships with Principal Investigators, other trial committees (e.g. Trial Steering Committee (TSC) or Executive Committee), sponsor and regulatory bodiesThe responsibilities of the other trial committees are presented in the protocol. Figure 2 presents the relationship of the DMC to other the other trial committees.Clarification of whether the DMC are advisory (make recommendations) or executive (make decisions)In accordance with MRC guidelines the DMC are advisory to the Trial Steering Committee. The TSC is the executive body for the trial. It contains representatives of the investigators and independent members (see separate guidance document).Any payments to DMC membersMembers should be reimbursed for any reasonable travel, accommodation or other costs (e.g. telephone) incurred. The CTU does not expect to pay DMC members or their employers. The need for DMC members to disclose information about any competing interestsCompeting interests should be disclosed. These are not restricted to financial matters involvement in other trials or intellectual investment could be relevant. Although members may well be able to act objectively despite such connections, complete disclosure enhances credibility. Most competing interests are acceptable if disclosed (see Appendix 1). In drug trials, DMC members should not use interim results to inform trading in pharmaceutical shares, and careful consideration should be given to trading in stock of companies with competing products.Organisation of DMC meetings Expected frequency of DMC meetingsIt is recommended that the DMC meet at least yearly and will otherwise depend on the wishes of the DMC and needs of the trial office will be considered when planning each meeting.Whether meetings will be face-to-face or by teleconferenceThe first meeting will be face-to-face. It is recommended that all subsequent meetings should be face-to-face too, with teleconference as a second option. The PI should try to attend in person if the DMC request their presence. Arrangements have been made for an early meeting, before many main outcome measure events have been accrued. This gives a test run for the DMC decision-making process and a test run for CTU report production. How DMC meetings will be organised, especially regarding open and closed sessions, including who will be present in each sessionDefinitions Closed session: Only DMC members, the trial statistician and, sometimes, other CD staff, should be present in closed sessions (although the DMC should be able to ask others to leave, also). Sessions attended only by DMC members may be referred to as executive sessions. Open session: Attended by those at the closed session, plus the PI(s), possibly the head of the CD, and perhaps also representatives of the sponsor, funder, or regulator, as relevant. Those attending only the open session may attend in person or, if appropriate by phone. The format will be: 1 Closed session: All parts of the report are discussed, and DMC discussion (( trial statistician at discretion of DMC) 2 Open session: Discussion with other attendees on any matters arising from the closed session. (this assumes that others will have read the open report in advance) 3 Closed session: extra closed session if necessary.Trial documentation and procedures to ensure confidentiality and proper communicationIntended content of material to be available in open sessions Open sessions: Accumulating information relating to recruitment and data quality (eg data return rates, treatment compliance. Toxicity details based on pooled data may be presented, although this may be presented by arm if toxicity is not the primary outcome measure. Total numbers of events for the primary outcome measure and other outcome measures.Intended content of material to be available in closed sessionsClosed sessions: In addition to all the material available in the open session, the closed session material would usually include efficacy and safety data by treatment group.Will the DMC be blinded to the treatment allocation? The DMC will not be blinded to the identity of the treatment arms. Who will see the accumulating data and interim analysis, and Interim data and analyses by treatment group (and the deliberations of the DMC) should be available only to those present in the closed sessions i.e. only members of the DMC, the trial statisticians and other members of the CTU trial team, as agreed by the DMC. DMC members must not share confidential information with people outside the DMC, including the PI. Who will be responsible for identifying and circulating external evidence (e.g. from other trials/ systematic reviews)Identification and circulation of external evidence (e.g. from other trials/ systematic reviews is not the responsibility of the DMC members. The PI (maybe the TMG, as a whole) and the trial team will collate any such information. To whom the DMC will communicate the decisions/recommendations that are reachedThe DMC will report its recommendations in writing to the Trial Steering Committee. This should be copied to the trial statistician (or trial manager) and should be sent via the CTU to coincide with TSC meetings. If the trial is to continue largely unchanged then it is often useful for the report from the DMC to include a summary paragraph suitable for trial promotion purposes. (See Appendix 2).Whether reports to the DMC be available before the meeting or only at/during the meetingIt is planned that the DMC will receive the report from the CTU at least 2 weeks before any meetings. What will happen to the confidential papers after the meetingThe DMC members should store the papers safely after each meeting so they may check against the next report. After the trial is reported, the DMC members should destroy all interim reports.Decision makingWhat decisions/recommendations will be open to the DMCThe possible recommendations are numerous and could include:- No action needed, trial continues as planned Early stopping due to, amongst other things, clear benefit or harm of a treatment, safety concerns on secondary outcome, futility, slow recruitment, or external evidence Stopping recruitment within a subgroup Extension of recruitment or follow-up Advising on or proposing protocol changes Note: The DMC will not advise on changes to the target sample size that are based on emerging differences between the trial arms. (The role of formal statistical methods, specifically which methods will be used and whether they will be used as guidelines or rulesA recommendation to discontinue recruitment, in all patients or in selected subgroups, will be made only if the result is likely to convince a broad range of clinicians, including those supporting the trial and the general clinical community. No formal interim statistical analyses of the principal outcome measure are planned. It is expected that the trial will terminate when the intended sample size has been achieved. How decisions or recommendations will be reached within the DMC The role of the chair should be to summarise discussions and encourage consensus. In each area of discussion the chair should give their own opinion last. Every effort should be made for the DMC to reach a consensus. If the DMC cannot achieve consensus, a vote should be taken, although details of the vote should not be routinely included in the report to the TSC, as it may inappropriately convey information about the state of the trial data.When the DMC is quorate for decision-makingEffort should be made for all members to attend. The CTU trial team will try to ensure that a date is chosen to enable this. Members who cannot attend in person should be encouraged to attend by teleconference. If, at short notice, any DMC members cannot attend at all then the DMC may still meet if at least one statistician and one clinician, including the Chair (unless otherwise agreed), will be present. If the DMC is considering recommending major action after such a meeting the DMC Chair should talk with the absent members as soon after the meeting as possible to check they agree. If they do not, a further teleconference should be arranged with the full DMC.Reporting To whom the DMC will report their recommendations/decisions, and in what formThe DMC should report in writing to the Trial Steering Committee, usually within 3 weeks after the meeting. This should be copied to the trial statistician and may be sent via the CTU. Unless the DMC is recommending that the trial protocol be change in some way, the letter to the TSC should not usually reveal any confidential information. An example of a letter from a DMC to the TSC recommending no action is presented in Appendix 2. Additionally, the letter should be copied to the PI, and head of the Cancer Division, although their copies should have any confidential information (i.e. comments on data by group on the main outcome measures) removed, and noted as such.Whether minutes of the meeting be made and, if so, by whom and where they will be kept Minutes from the meeting need not be detailed. A summary of the main points discussed with a list of clearly marked action points should be sufficient. It is recommended that separate minutes of open and closed session be made if the meeting is run in this format. The minutes for each session should be made only by someone who attends that session, probably a member of the CTU trial team. This should be agreed at the start of the meeting. Consideration may be given to a secretary or perhaps a Trial Manager from a different trial to take notes (i.e. someone experienced in noting but not involved with the trial). All members of the DMC should see and comment on the minutes. The DMC chair will be responsible for signing off all minutes. What will be done in the instances of disagreement between the DMC and the body to which they reportThe TSC has ultimate responsibility for the trial and assumes primacy. However, the TSC should report to DMC how they have acted upon the DMCs recommendations. If the DMC has serious problems or concerns with the TSC decision, a meeting of these groups should be held. The information to be shown would depend upon the action proposed and the DMCs concerns. The meeting should be chaired by a senior member of CTU staff or external expert who is not directly involved with the trial. Depending on the reason for the disagreement confidential data will often have to be revealed to all those attending such a meeting.After the trialPublication of results The PI(s) have responsibility that trial results will be published in a correct and timely manner. The TSC is the committee that should oversee this process.The information about the DMC that will be included in published trial reportsDMC members will be named (unless they specifically ask not to be) in the primary published report. A brief summary of the timings and conclusions of DMC meetings should be included in the body of this paper. Whether the DMC will have the opportunity to approve publications, especially with respect to reporting of any DMC recommendation regarding termination of a trialThe DMC members should be given at least 2 weeks, and if possible a month,to read and comment on any draft publications that report outcome measures and/or details of the DMC. This may be done simultaneously to other groups reviewing the draft manuscript (e.g. Trial Steering Committee, trial investigators).Any constraints on DMC members divulging information about their deliberations after the trial has been publishedThe DMC should not discuss confidential issues from their involvement in the trial until 12 months after the primary trial results have been published, unless permission is agreed with the TSC. They should not trade in stock of companies affected by the trial until the results are public knowledge. Version produced: 12 June 2003 Figure 1: Trial design flow chart  Figure 2: Relationships between trial committees  Abbreviations: CD Cancer Division CTU Clinical Trials Unit DM Data Manager DMC Data Monitoring Committee EUDRACT European Union Directive on Randomised Controlled Trials ISRCTN International Standardised Randomised Controlled Trial Number LREC Local Research Ethics Committee MRC Medical Research Council MREC Multi-centre Research Ethics Committee PI Principal Investigator TA Trial Assistant TM Trial Manager TMG Trial Management Group TSC Trial Steering Committee Appendix 1: Conflicts of interest forms (To be added) Appendix 2: Suggested report from DMC to TSC where no recommendations are being made [Insert date] To: David Guthrie, Chair MRC Urological Trial Steering Committee Dear Dr Guthrie, The Data Monitoring Committee (DMC) for the MRC RE04 trial met on [meeting date] to review its progress and interim data. [List members] were able to attend the meeting and review the report. We congratulate the trial organisers and collaborators on the progress and conduct of the trial and the presentation of the data. The trial question remains important and, on the basis of the data reviewed at this stage, we recommend continuation of the trial according to the current version of the protocol [specify protocol version number and date] with no changes. We shall next review the progress and data [provide approximate timing] Yours sincerely, Dr J Joffe Chairman of Data Monitoring Committee On behalf of the DMC (all members listed below) DMC members: Dr Jonathon Joffe (Clinician), Huddersfield Prof. Mike Lind (Clinician), Hull Dr Keith Wheatley (Statistician), Birmingham  Appendix 3: Details of the interim analysis plan (To be added) ( It is advised that the sample size is not revised on the basis of the treatment effect at an interim analysis. This is because the type I error and power would have to be recalculated on the basis of the correlation between the observed estimate of the treatment effect and the final target estimate. The problem arises because the correlation is not clear at this interim design stage. It is analogous to the problems of interim looks at the data but is more difficult to assess because we are dealing with estimation. 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