‘Bundled’ or ‘umbrella’ protocols
We use adaptive protocols about 7 times per year, to execute first-in-human (FIH) trials with as many as 6 parts. Adaptive protocols work well and save time, so they’re the best choice when time is more important than cost. The MHRA refers to such protocols as ‘bundled’ protocols: they’re also known as ‘fusion’ or ‘umbrella’ protocols. MHRA and research ethics committees (REC) look favourably upon adaptive FIH protocols, which typically include SAD, MAD, food/fasting, elderly, and patient cohort(s).
We’ve submitted many ‘bundled’ protocols to MHRA and REC. The submissions are complex and time-consuming to prepare, because
- protocols must incorporate the necessary flexibility, while being prescriptive enough to reassure reviewers
- text must be crystal clear, to avoid ambiguity
- doses in each part must be defined in relation to what’s been given in previous parts
- multiple information and consent forms (ICFs) are usually needed, to cover each part of the trial
- protocol & ICF must be very carefully constructed, to allow flexibility of dosing levels without recourse to amendments that need regulatory or REC review
We’ve an excellent track record in obtaining approval of applications that we make on behalf of sponsors of our FIH trials.