What are clinical trials? What is their purpose?
Clinical Trials of an Investigational Medicinal Product (CTIMPs) are studies designated and authorised by the Medicines and Healthcare Regulatory Agency (MHRA) which trial a new medicine or an existing medicine for a different condition. The study can assess what doses should be given, how well the drug works in a population (its efficacy), how it works within the body (pharmacodynamic and pharmacokinetic properties) and any unwanted side effects. This enables a better understanding of trial drugs and wider access for patients to drugs for a given condition. The future of clinical trials is changing as we look to advanced therapies (ATIMPs) which include gene therapy, cell therapy or any tissue engineered product.
Running a clinical trial is no mean feat and will take on average 5-8 years and millions of pounds from initial creation of a compound in a laboratory to an efficacious dosage form licensed by the MHRA. During this time the drug will be tested on hundreds, if not thousands of subjects (comprising healthy volunteers and patients with the disease in question) and will be strictly managed to ensure optimum patient safety and integrity of data collected. All CTIMPs are overseen by an ethics committee which works independently to ensure the rights, safety and well-being of any research participant.
How is pharmacy involved and why?
Clinical trial drugs need to be securely managed with detailed accounts maintained pertaining to their storage, dispensing, return and destruction. The management of drugs to be used within a CTIMP is written in to various UK and EU legislation, and therefore clinical trial trained personnel are required to manage these medicines and the specific records which need to be completed.
Monitored by the MHRA, it is imperative that the handling of clinical trial drugs are done in accordance with Good Clinical Practice (GCP), a set of international ethical and scientific quality standards to which a clinical trial involving humans should be run.
Clinical trial drugs are stored separately to “standard” medicines given to our in-patients, and the temperatures to which they are stored are closely monitored; clinical trial drugs are usually brand new drugs and therefore less is known regarding their stability at a given temperature. When clinical trial medication is dispensed, extra accountability records are to be completed detailing what drug is given to which patient – the MHRA stipulate that a trial should be conducted in a transparent way and all records should clearly indicate what occurred, ensuring that at any time (even 20 years after a study has finished) it could be understood what happened and a trial re-created. Additional labelling is required by law for all clinical trial drugs; this is assessed by the pharmacy team and tailored to each study depending upon what is already included on the trial drug itself.
The trials team dispense all types of drug to trial patients from patches, eye drops, injections and capsules and make use of the large aseptic suite for medicines which require specialist handling and preparation. Extra precautions (how the drug is packaged or labelled) may need to be taken in order to maintain “the blind” if a patient or research nurse/doctor does not know what medicine the patient is receiving.
The pharmacy team work with the research nurses to understand the study and the specific needs of the patient; trial drug can be stored outside of the dispensary in A&E or ITU if this is where the patient population is and the drug would be needed out of standard working hours. Any potential issues are identified early on in the trial “set-up” process to enable a study to open smoothly and quickly at the Trust – giving the local population the chance to be involved in one of many research studies, with an aim to further progress the trial drug or improve the health and well-being of the subjects involved.
Professors working at the University utilise the experience of the team in designing a study of their own, from the basics of drug storage, cost and procurement, to seeking or manufacturing placebo drugs for double-blind studies.
We are a research active department and have several pharmacists working on the ward whilst undertaking a PhD. One of the current projects is looking at genetics and the relationship between a person’s genome and how efficacious a medicine is – can it be predicted how one will react to a medicine before it is given? If this answer is established, then in years to come it could influence practice and may lead to a different dose being given or even a different medicine being selected for a patient once the diagnosis has been made.
Meet your Royal Pharmacy Trials Team
A large, dedicated clinical trial pharmacy team support over 150 CTIMP studies running across The Royal and Broadgreen sites. The team comprises specialist assistants and dispensers, technicians and specialist technicians for haematology studies and early-phase studies run through our Clinical Research Unit, and specialist pharmacists.
In addition to working on CTIMP studies we have ATMIP and ‘device’ studies open involving a wide variety of disease areas from Alzheimer’s disease to breast cancer. The team works closely with colleagues around the hospital (research nurses, doctors, assistants, and research & development team), the University and the trial representatives to give a streamlined service to patients and colleagues to make sure drug is available in a fast and safe manner.
The team champion research within the pharmacy department to ensure that more patients who are eligible for clinical trials are given the opportunity to partake in these studies. They are working closely with specialist pharmacists throughout the department to increase their understanding of studies that are open within their clinical expertise so they may better engage the research team and potential participants they come across within their day to day clinical duties.