Cancer trials Pharmacy Advisory Service (CPAS)
What is the Cancer trials Pharmacy Advisory Service (CPAS)?
CPAS is a multi-disciplinary national team of pharmacists, pharmacy technicians, research nurses and clinicians. It was set up by the NIHR Clinical Research Network (CRN) Cancer Specialty to advise Chief Investigators and Clinical Trials Units on the Investigational Medicinal Product (IMP) and pharmacy content of their protocols. The service has been running since 2008 and has been shown to improve the quality of clinical trial protocols.
Why use it?
The aim of the service is to help clinical trials on the CRN Cancer Portfolio run as smoothly and quickly as possible, and to improve quality of care and management of risks in prescribing, preparing and administering systemic anticancer therapies. A review of current trials has raised a number of issues which have made trials difficult to implement at the local level and which have led to delays and problems in areas such as:
- dose adjustments
- dose banding
- missing pharmacy information, drug stability data unclear
- supply of standard therapy/IMPs (including issues around excess treatment costs)
- safe administration of IMPs
CPAS helps investigators through these problems, achieving some consistency across Cancer studies. Investigators who have protocols reviewed in this way have reported that it was a helpful and constructive process, which reduced the number of protocol amendments that were required once the trial had opened to recruitment.
What kind of issues will CPAS comment on?
Taking for example a trial involving chemo-radiotherapy that was reviewed, there were a number of deficiencies in the final draft protocol which needed addressing, particularly with regard to drug information and drug/dose administration. As a consequence, members of CPAS made 27 important recommendations aimed at clarifying and improving the protocol. These recommendations were fed back to the trial team prior to the protocol being finalised, 93% of the comments were taken on board and the final protocol was modified to address the issues raised. Addressing these issues prior to IRAS submission reduced potential variations and errors across centres in the preparation and delivery of drugs being used, and also reduced the quantity of modifications to the protocol over the life of the trial.
Which protocols need to be submitted?
Any cancer clinical trial can be submitted voluntarily for review. For all drug trials approved by the CRUK Clinical Research Committee (CRC), CPAS protocol review is mandatory, prior to inclusion in the NIHR CRN Cancer Portfolio. It is also advisable to submit the study pharmacy operating manual to be reviewed at the same time as the protocol if available. If not, this and any other information such as drug labels or sponsor’s standard prescription form should be submitted for review as soon as available. (CPAS is required to review this pharmacy documentation at some stage prior to the study opening, even if it is not available at the same time as the draft protocol is submitted for review).
How long will it take?
CPAS will provide its review to the investigators within four weeks of receiving the protocol and any additional pharmacy information.
When should I submit the protocol?
Any time after approval by the funder and at least six weeks prior to regulatory submission, (to allow time to receive and act on CPAS comments). The protocol can either be reviewed once the drug treatment section is more or less complete, or the trial team can approach CPAS prior to the protocol being finalised in order to get their advice on any issues/queries/best practice.
How do I submit to CPAS?
Protocols as well as other trial documents such as pharmacy manuals, patient information sheets and trial labels can be submitted to CPAS for review by emailing them to the CPAS Pharmacy Advisor Joanna Askey (mGPhC) at email@example.com
Do I have to accept all the recommendations?
No; whether or not the recommendations are incorporated into the final protocol is at the Investigator’s discretion, though we have found that the majority of review comments have been welcomed and the protocols amended accordingly. Recommendations will be classed as either important or general depending on their significance, and CPAS reserves the right to negotiate about any initial non-acceptance of important recommendations. Following evidence that important recommendations have been addressed in a revised protocol, the Chief Investigator will be supplied with the NIHR CPAS Kitemark to include on the final clinical trial protocol, as evidence of its endorsement by CPAS, and providing a pharmacy quality standard.
How does the CPAS review fit with the Health Research Authority (HRA) Pharmacy Assurance?
CPAS and HRA reviews occur at different stages of clinical trial set-up. The CPAS review is aimed at finessing the clinical trial protocol and associated documents prior to regulatory approval. HRA Pharmacy Assurance is undertaken as part of regulatory approval and provides a single review that sites would normally conduct as part of site set-up. In theory, a trial that has been through the CPAS process will likely proceed through the HRA Pharmacy Assurance process more smoothly and quickly. Where possible, the same pharmacist or pharmacy technician undertaking the CPAS review might also undertake the HRA review.
Where can I get more information?
Please contact the CPAS Pharmacy Advisor Joanna Askey (mGPhC) at firstname.lastname@example.org
Join our CPAS Review Panel
Due to growing demand, CPAS is looking for volunteers to join the review panel. As a reviewer, you will help improve the quality and content of approximately four trial protocols each year, before they are added to the NIHR CRN Cancer Portfolio. Panel members are also offered the chance to attend bi-annual meetings (travel expenses paid) to network, share ideas and influence current research and policy at a national level.
If you’re interested in joining this friendly, multidisciplinary panel and can offer your expertise, please get in touch email@example.com