Support for Clinical Trials
Have you read about Advice, Consultancy & Collaboration?
The most effective method of conducting a clinical trial is to use a multidisciplinary team approach. A team comprising experts on the major aspects of the trial, including a biostatistician, will increase its chances of success. All trials that are subject to regulatory scrutiny (for new drugs etc) require a professional statistician to be part of their team to advise in all stages of the trial and most large multi-centre trials do likewise.
CEBU has considerable expertise and experience in collaborating with clinical researchers carrying out investigator-led RCTs. A CEBU statistician included as a member of the investigator team can provide advice and/or assistance at all stages of a clinical trial, not just at the beginning and end, see CEBU roles in the conduct of RCTs for a detailed list.
CEBU RCT statistical support package
To encourage research groups to include a member of CEBU in their study team, we have put together a minimum cost package for statistical support for a new research project. For a fixed fee, CEBU will provide a statistician to be a member of the investigator team, providing support and advice during all phases of the RCT.
The package is designed for a study lasting 1-2 years, typically conducted by a research fellow or other junior researcher. The estimates given are for a fairly small, simple study (approximately 100 data items) which does not require extensive hands-on input from the statistician during the running of the study. If a study is more complex or will need additional input from CEBU over and above the expected amount, this basic budget will need to be revised. This should be discussed with CEBU before writing a budget for statistical input.
You may find this checklist useful to record and document discussion of CEBU’s involvement in an RCT as agreed with the lead clinician and CEBU statistician.
You should also consult Research Development & Ethics at RCH for support and advice on running a clinical trial.
Guidelines for writing a protocol (PDF 40 KB)
CONSORT Statement (Consolidated Standards of Reporting Trials) provides standard guidelines for reporting randomised trials, and has been adopted by all major medical journals. These detailed guidelines consist of a checklist that authors should use for reporting trials. This checklist is also a useful guide when writing a research proposal.
