Richmond Pharmacology actively works
to maximise return on our Sponsors’ trials,
having routinely developed and conducted
adaptive protocols to support rational
“no-go” or “where to go next” decisions.
The benefits of using adaptive design can
be best exploited in combined “umbrella”
protocols, whereby an entire early phase
programme from First-Time-in-Human
(FTIH) to Proof of Concept (POC) can be
performed within one trial protocol in
a single centre. Value can be added by
integrating ethnic comparison elements
and further drug development can be
de-risked by integrating intensive cardiac
assessments and other biomarkers into
a combined protocol.
Our transparent and systematic 3-step approach ensures that all potential adaptive features, their boundaries and study control mechanisms are considered and fully described to allow continuous learning from data that is being gathered. Such a strategy allows us to adapt and modify the trial design without undermining the validity and integrity of the trial.
We have a highly specialised medical team who, in collaboration with our dedicated in-house data management team and multidisciplinary partners, maintain close communication with our Sponsors for competent and fast decision making. Our goal is to constantly review emerging and quality controlled data to modify the study within the pre-approved limits and boundaries to meet the study objectives and guarantee a rapid trial progression while focussing on participants’ safety.
Richmond’s established adaptive
protocol format enables us to run
entire Phase I programmes, including
first evaluation of efficacy in groups
of patients as part of one protocol
and following a single regulatory
and ethical approval. We have an
excellent track record for starting
studies on time and effectively
managing ethics and regulatory
submissions, with processes that are
tailored to ensure a minimum of
queries and rejection letters.
Whilst progressing through the various parts of a combined trial, there is no need to share interim data with the competent authority or ethics committee, unless there is intention to go beyond pre-defined and approved adaptive boundaries.