NSW Cancer Trials Network Network Portfolio Policy October 2012 E12/18446 Cancer Institute NSW Page 1 of 7
Contents BACKGROUND... 3 NSW CANCER TRIALS NETWORK PORTFOLIO KEY PRINCIPLES... 3 PORTFOLIO COMPLIANCE CRITERIA... 4 PORTFOLIO EXCLUSIONS... 5 CANCER INSTITUTE NSW CLINICAL TRIAL WEB PORTAL... 5 PUBLICATION OF PORTFOLIO... 6 PRINCIPLES OF PORTFOLIO MONITORING AND REVIEW... 6 FURTHER INFORMATION... 6 ENDNOTES... 6 E12/18446 Cancer Institute NSW Page 2 of 7
Background The vision for the NSW Cancer Trials Network is to create a world leading cancer clinical trials network with the infrastructure, knowledge and resources to support high quality, industry-independent i cancer clinical trials ii that will create new evidence to more rapidly drive improved cancer outcomes in NSW. Through the Cancer Institute NSW Clinical Trials Program, the Network is supported via investment in infrastructure and development and implementation of initiatives to drive both collaboration and performance improvements across the NSW Cancer Trials Network. One of the major funding schemes supported through the Cancer Institute NSW Clinical Trials Program is the Clinical Trial Staff (CTS) Grant Scheme. This scheme provides funding to employ 38 full time equivalent clinical trial staff (trial coordinators, trial nurses, data managers) across the NSW Cancer Trials Network. The aim of the Cancer Clinical Trials Staff (CTS) Grant scheme is to: 1. Provide additional infrastructure and flexibility, including workforce sharing for Clinical Trial Units across a Local Health District, leading to: Increased number of participants in NSW Cancer Trials Network Portfolio compliant, industry-independent cancer clinical trials; Increased support for high quality, NSW Cancer Trials Network Portfolio compliant, industry-independent cancer clinical trials; Increased support for patients, their families and cancer specialists, participating in cancer clinical trials; 2. Facilitate greater collaboration across the NSW Cancer Trials Network. The clinical trial staff employed through this scheme are required to work exclusively on the portfolio of industry independent, compliant cancer clinical trials that will directly inform clinical practice. NSW Cancer Trials Network Portfolio Key Principles Establishment of a Network Portfolio ( portfolio ) of cancer clinical trials is one of the strategic research investment initiatives that will support the strategy outlined in the NSW Cancer Plan 2011-2015 to develop and apply a mechanism to prioritise research initiives. The portfolio of compliant cancer clinical trials will ensure that resources funded through the Cancer Institute NSW Clinical Trial Staff Grant Scheme are utilised to support high quality, well designed cancer clinical trials, which are industry-independent. The expectation is by directing resources across a more focussed portfolio will create new evidence to more rapidly drive improved cancer outcomes in NSW. It also ensures there are agreed and transparent priorities established across all Clinical Trial Staff Grant fund holders across the NSW Cancer Trials Network. Clinical trial staff employed through this scheme will work exclusively on a portfolio of cancer clinical trials that are compliant with a list of defined principles and criteria. Allocation of clinical trial staff grant funded resource onto a clinical trial can take place following a clinical trial being determined as compliant with the portfolio criteria E12/18446 Cancer Institute NSW Page 3 of 7
outlined in this policy. iii Compliance is a self-determining mechanism at a clinical trial unit, Local Health District or Sponsor level at the time of trial registration. Refer to Cancer Institute NSW Web Portal section. In collaboration with the Cancer Institute NSW, a Clinical Trials Leaders Group iv has been established to provide strategic and operational leadership to the NSW Cancer Trials Network. At the leaders group meetings on 15 th February and 22 August 2012, the group agreed to support the implementation of a portfolio compliant with the criteria outlined below. Portfolio Compliance Criteria It should be noted that if there is a conflicting interpretation of any of the criteria outlined within the three categories below, the Cancer Institute NSW will consult with necessary parties to determine compliance and will thus make the final decision on portfolio inclusion. Category 1: Prospective, Interventional Controlled Cancer Clinical Trials For a cancer clinical trial to be included onto the portfolio it must be compliant with all of the following criteria: 1. The trial is prospective, interventional and controlled v ; vi 2. The trial has been peer reviewed ; 3. The trial has scientific and ethical approval; 4. The trial data are owned by the industry-independent sponsor for analysis and dissemination; 5. The industry-independent sponsor intends to publish the results of the trial in peer reviewed literature; 6. The trial will contribute new knowledge which will influence clinical practice; 7. The trial is listed on a recognised clinical trials register prior to the enrolment of participants. Category 2: Prospective, Interventional, Non-Controlled Cancer Clinical Trials The Cancer Institute NSW acknowledges there may be other cancer clinical trials that are compliant with all Category 1 criteria except for being non-controlled (single arm) by design, that warrant acceptance onto the portfolio. The Cancer Institute NSW, in consultation with the Clinical Research Leaders Group, has developed additional criteria to allow for the inclusion of such trials. For a non-controlled (single arm), cancer clinical trial to be included on the portfolio it must be compliant with Category 1 criteria 2-7, and in addition compliant with the criteria below: Prospective; Interventional; Non-Controlled Phase 2 or 3 Cooperative Clinical Trial Group Sponsor E12/18446 Cancer Institute NSW Page 4 of 7
Category 3: Palliative Care Mixed Patient Population Clinical Trials The Cancer Institute NSW will include such clinical trials onto the portfolio if they are compliant with all Category 1 criteria. In addition, the industry independent sponsor must be able to demonstrate a planned inclusion of 80% cancer patients into the trial at the time of trial registration vii. A clinical trial unit conducting such a trial will have Cancer Institute NSW clinical trial activity reporting obligations, with the number of cancer patients enrolled reported. The Cancer Institute NSW will monitor the number of cancer patients included and will require justification if such an inclusion rate is not being met. Portfolio Exclusions The Cancer Institute NSW recognises the below studies and/or clinical trials are all important areas of cancer research; however, they are not within scope of the portfolio. They will not be included onto the portfolio listing of clinical trials to which Cancer Institute NSW funded clinical trial staff grant funded resources can be directed. Primary prevention trials within the general population and in healthy volunteers viii Phase 1, pilot or feasibility interventional clinical trials Prospective non-interventional, observational studies All other research studies ix Please note that non Cancer Institute NSW funded resource available within a clinical trial unit can be resourced to any trial or research study. Cancer Institute NSW Clinical Trial Web Portal To improve the efficiency and accuracy in the Cancer Institute NSW clinical trial register and clinical trial activity data-reporting process, an online clinical trial web portal is under development. This web portal will house a searchable master clinical trials list of all cancer clinical trials active in NSW, including portfolio and non-portfolio cancer clinical trials and both industry and industry-independent sponsored. The first site in NSW to seek HREC or research governance approval or the trial sponsor will be responsible for the online registration of new trials conducted in NSW. The nominated person, group or organisation will complete the online clinical trial registration form within the web portal. There will be an option as part of the online registration process to request inclusion of a clinical trial onto the portfolio; if compliant will all required criteria. The Cancer Institute NSW will classify the clinical trial as a portfolio trial and this will be clearly identifiable within the portal. Users of the portal will be able to search by all cancer clinical trials in NSW or portfolio trials only. Within the portal, a clinical trial unit in NSW will be able to link their unit to the cancer clinical trials they are conducting (portfolio and non-portfolio) and will subsequently report high-level activity data x against those trials. The Cancer Institute NSW will E12/18446 Cancer Institute NSW Page 5 of 7
then report clinical trial activity annually at both a state wide and local health district level. Publication of Portfolio A searchable master trials list and portfolio specific listing will be accessible through the web portal. User access will be granted at a trial unit, local health district or sponsor level, with access restrictions applied, as required. In due course, a publically searchable register of all cancer clinical trials active across NSW will be available, based on trials registered in the web portal. Principles of Portfolio Monitoring and Review The Cancer Institute NSW will be responsible for the ongoing review and monitoring of the portfolio, with advice from relevant parties as required. If it becomes apparent that changes to the portfolio principles and criteria are necessary, the Cancer Institute NSW will make such amendments following consultation with the Clinical Research Leaders Group and other relevant parties as required. The policy document will be updated accordingly. Further Information Any questions or queries relating to the portfolio, its purpose or this policy document should be directed via email to the Cancer Institute NSW Clinical Trials Program Team at clinical.trials@cancerinstitute.org.au. i Industry-independent is when the data collection, analysis and ownership of data together with dissemination of findings lies within the control of the research collaborative group or individual investigator in an investigator initiated trial. ii Within the scope of the Cancer Institute NSW Clinical Trials Program, a clinical trial is defined as an interventional study whereby trial participants receive specific interventions according to the research plan or protocol. An intervention may include a medical treatment or procedure, such as a drug or device, surgical method, radiation therapy, exercise, physiotherapy, cognitive therapy methods or changes to participants' behaviour, for example, diet. Clinical trials may compare a new medical approach or intervention to a standard one that is already available, to a placebo or to no intervention. When a new treatment, approach or other type of intervention is being studied, the clinical trial will test the safety and efficacy of the intervention by measuring certain outcomes in the participants. iii Clinical researchers in NSW are free to direct non Cancer Institute NSW funded clinical trial resources within a unit or institution towards any other trial, clinical study or endeavour of their choosing. iv Clinical Research Leaders Group as defined in the current Terms of Reference (March 2012 Trim Record E11/23072), this group comprises Senior Clinical Researchers with one representative nominated from each fund holder across the NSW Cancer Trials Network and E12/18446 Cancer Institute NSW Page 6 of 7
at least 2 nominees from the Cancer Institute NSW independent Clinical Trials Review committee. v Controlled clinical trial is one defined as a clinical trial that includes an active comparator (control) group. The comparator group receives a placebo, another treatment/ intervention or no treatment / intervention at all. vi The Australian Code for the Responsible Conduct of Research, 2007 (developed jointly by the NHMRC, ARC and Universities Australia) definition of peer review will be applied in this process. The definition will be expanded to include trials which have been approved through the review process of national cooperative groups, and have the endorsement of the group. vii Clinical trials compliant within this category can be registered in the Cancer Institute NSW Clinical Trial Web Portal. viii Prevention is a key pillar of cancer control in NSW. Whilst prospective and controlled prevention clinical trials in cancer patients with a high risk of recurrence will be included in the portfolio, the conduct of high volume primary prevention trials within the general population and in healthy volunteers is not within the scope of the Cancer Institute Clinical Trials Program or Portfolio. Such trials are required to enrol extremely large numbers of participants, and the use of clinical trial staff funded resource in this way would limit the Network s ability to conduct the trials necessary to improve treatment options and outcomes for people with cancer. ix Other research based studies including population and public health research including retrospective cohort studies and audits, social science studies are not within the scope of the Cancer Institute NSW Clinical Trials Program. These studies are also excluded from the portfolio. x Clinical trial units will be provided with training, user manuals and user access to the CINSW portal following external release. E12/18446 Cancer Institute NSW Page 7 of 7