A safe, practical, and scientifically robust trial design, specified in a clear, well-written protocol, is the key to a successful trial. Whether you have a near-final protocol or just a draft synopsis, we can design a safe, ethical trial that delivers the data you need.
If you’re early in the planning stage, we offer a consultation service to help you design your trial. We specialise in early phase clinical research, including first-in-human and complex trials, such as multipart ‘umbrella’ protocols, and trials with specialised clinical and laboratory procedures, such as bronchoscopy, EEG, and flow cytometry. We can help you to
- anticipate and mitigate likely concerns from the UK regulatory authority (MHRA) and ethics committee
- plan any further preclinical work required before submission
- design a trial that’s safe, scientifically sound, and feasible
Designing a trial is a team effort. You’ll benefit from the combined experience of our multidisciplinary team, including
- a Clinical Project Manager/Medical Writer, overseen by our Director of Clinical Science, who provides expertise in trial design and regulatory matters
- a Principal Investigator – who reviews the preclinical data, does the risk assessment, and ensures that the proposed trial is safe
- our statistics and data management teams – who provide expertise in randomisation and analysis, and ensure that the trial will meet its objectives
- our recruitment and ward teams – who have invaluable insight into the logistics and feasibility of the trial
- HMR’s pharmacy and laboratory teams – who advise on feasibility and technical aspects
We’ve extensive experience of writing protocols and synopses for a wide range of trial designs. Our protocol template incorporates the experience we’ve gained over nearly 3 decades of running early phase clinical trials – it includes all the information required by the MHRA and ethics committee, and pre-empts many of the difficulties that might otherwise arise during the trial. In particular:
- We know how important it is to have dose escalation and stopping criteria that are flexible enough to allow adaptive responses to emerging trial data, while ensuring the safety of trial subjects. Comprehensive, clearly explained rules are essential – including them in the protocol minimises queries from the MHRA and ethics committee, shortens approval times, and optimises trial progress by reducing the need for substantial amendments.
- Our protocols are designed to cope with unexpected results and events. They accommodate design changes that might be required during the trial, from the addition of extra time points and cohorts to changes in dosing regimens. The flexibility in our protocols, combined with that in our information and consent forms, minimises the need for amendments and their associated delays. We pride ourselves on the quality of our documents. We achieve high-quality first drafts by the use of sophisticated templates, thorough QC checks, and comprehensive reviews by experienced senior staff. We aim to reduce both the sponsor’s review effort and the time needed to finalise documents. If you already have a near-final protocol, our multidisciplinary team (see above) do an extensive review, so that you take advantage of our 20 years’ experience of designing and running early phase clinical trials. We’ll give detailed feedback on the proposed design, including suggestions for improving feasibility and flexibility.
We ensure that the trial is designed to run as efficiently as possible. For example, we build the protocol such that, where possible, different parts of multipart trials can run in parallel, subject to strict safety criteria.