Industry

To be a UKCRC Registered CTU each CTU must have a proven track record in high quality clinical trial conduct and publications, have appropriate infrastructure and to be working to an approved set of SOPs. Applications are reviewed by an International panel of expert trialists.

Registered CTUs frequently have good knowledge of appropriate study sites and investigators for clinical trials in specific medical fields. Where a CTU has run trials in the area before then it will already have an existing collaboration of sites and investigators with a proven track record that could rapidly be engaged in a new trial. If a company required recommendations for individuals to sit on independent trial oversight committees (e.g. Data Monitoring Committee or Trial Steering Committee), Registered CTUs are often well-placed to give such advice.

CTUs differ in their fields of expertise, but the UK CRC search function allows CTUs with specific interests to be identified. A CTU would typically have developed significant academic expertise in these areas and either have clinicians working in the CTU or close links with clinicians who can provide the necessary expertise to assist the CTU in the design of a trial.

One of the major advantages of collaborating with a CTU is the independence that they offer. Their independence from industry and commercial interests in the analysis, presentation and publication of trial results offers a substantial advantage when seeking acceptability from clinicians, regulators and healthcare providers. Registered CTUs have experience of interacting with regulators and many have experience of regulatory submissions of trial data which can assist a company greatly.

Registered CTUs are well aware of the requirements for trial approvals and conduct in the UK, and often elsewhere. Although the requirements can be complex, the experience of CTUs can ensure a smooth and timely approval process and reduce the risks of delays in getting trials started.

Classical study designs may not provide the best or most efficient way to test a new treatment or device. Many Registered CTUs have expertise in novel trial design methodologies which can offer a substantial benefit to industry by reducing both the time and cost of providing the necessary data.

In addition to the potential to accelerate study start-up times and recruitment, Registered CTUs would provide oversight of the entire trial (or indeed research program) including appointing the necessary independent committees for a trial to run. CTUs can also enhance other aspects of trial conduct. For example, they will have experience of risk-adapted approaches to monitoring, including central statistical monitoring, which can be both as effective as and less costly than traditional on-site monitoring approaches.

Registered CTUs can provide expertise in areas that relate to the trial in question but also develop it further. For example, many CTUs have expertise in systematic reviews and meta-analyses which can either ensure the trial is addressing the correct question or place the results of a trial in the context of other available data and therefore increase its impact. CTUs may continue to analyse the trial database and address secondary but significant questions of interest which ensure that the trial results are of interest for longer and may generate suitable hypotheses to be addressed in future trials which could expand the indication for the drug or device. CTUs can also advise on and provide health economic analyses (both of in-trial data but also potentially extrapolating beyond it) which can be very beneficial when interacting with healthcare providers (e.g. NICE).