first-in-human patient trials

We do first-in-human (FIH) trials of almost all types of molecule – from small molecules to biological products – and for most systems, such as CNS, respiratory, cardiovascular and GI tract.  We do about 8–10 FIH each year.   We also do almost all other types of trial, including bioequivalence, bioavailability, interaction, PET, biosimilar, ‘biobetter’, PD, thorough QT, and radiolabelled.  Although most FIH trials are done in healthy volunteers, we’re equally capable of doing them in special populations, such as elderly, postmenopausal women, surgically sterilized women, obese, smokers, alcohol-dependent, ethnic groups, slow metabolisers, and cohorts of patients with a wide variety of target disease.

We have full facilities for cardiopulmonary resuscitation, including cardiac defibrillation, external pacing, and airway intervention.  We’ve set up our own Resuscitation Committee, Resuscitation Team and Resident Medical Officer, in accordance with European Resuscitation Council guidelines.  Team members each carry a pager, which when activated identifies the precise location in the building of the emergency.  The Resuscitation Team comprises 1 advanced life-support trained physician, 2 immediate life-support trained staff, and 2 basic life-support trained staff, who are available 24/7.  All ward staff are trained in life support.  We do regular practice emergency scenarios and document them.  Our physicians attend shadowing sessions at Central Middlesex Hospital, under the supervision of a consultant anaesthetist.  If necessary, we can transfer a patient by ambulance to the Central Middlesex Hospital, which is 500 m from HMR, or to another local hospital.