Phase I are exploratory clinical trials involving small numbers of healthy volunteers, or volunteers with a specific disease, who normally expect no therapeutic benefit, making these studies non-therapeutic trials. Instead, the studies aim to establish the pharmacokinetic properties and the appropriate dosage of the new medicine. This is achieved by progressively raising the dose of the medicine, from a very low dose, until reaching the expected therapeutic dose. Whilst increasing the dose of the medicine, careful assessments of its action and tolerability are made, alongside assessments of the mental and physical health of study volunteers. A pharmaceutical physician will usually make these assessments, with the trials being conducted in a safe, carefully controlled environment; this may be within a clinical pharmacology unit linked to a hospital, or in a stand-alone high quality facility with full-time physicians, nurses, and clinical support staff.
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Phase II clinical trials
The next phase of clinical trials involves relatively small numbers of patients, and is where the first evidence of therapeutic activity emerges. These studies also ensure no unacceptable side effects are produced, and help guide the dose and treatment regimen for use in larger subsequent trials. In this phase, pharmaceutical physicians work with clinical investigators, with the study being conducted in an academic medical centre, with which the physician is closely associated. Both for Phase II and the more extensive trials that follow, physicians will have a major role in developing the trial protocol, providing input into the analysis, interpretation and reporting of trial results, as well as ensuring ethical compliance with standards. To do this, physicians will work as part of a multi-disciplinary team responsible for decisions on how further development should proceed.
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Phase III clinical trials
Phase III trials are conducted on a much larger scale, often using between 2,000 – 5,000 patients, with the new medicine being tested alongside an established "gold-standard" treatment, or a placebo. Additionally, these trials are often conducted internationally, with company headquarters delegating responsibilities to its local subsidiaries. The aim of phase III trials is to satisfy the appropriate regulatory authorities of the efficacy and safety of the new medicine, in order to obtain a Marketing Authorisation. As such, there should not be much new scientific information arising from a phase III clinical study, with the exception of uncommon adverse effects that are only detected in larger long-term statistical samples.
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Phase IV clinical trials
Once the medicine has been licensed, as a result of the phase III trials, it is studied in huge numbers of patients to further characterise its efficacy and rare side effects. These Post-Authorisation Safety Studies essentially provide a real-world view of the medicine. As mentioned above, a pharmaceutical physician working in phase III or IV clinical trials will be involved in decisions made outside of the Research and Development group regarding, for example, marketing plans, medical literature for the new medicine, and regulatory procedures.
Clinical research physicians A clinical research physicians working in a pharmaceutical company or CRO, has the chance to work at the frontier of medical knowledge and help develop the next generation of medicines. It is certainly exciting to be among the first to see new breakthroughs, but a balanced view of potential benefits is important, as a major part of any doctor's job is safety assessment. So, alongside monitoring improvements to patients' health, the doctor must also be on the lookout for adverse events. For more information on the role of clinical research physician, please visit the ABPI's brochure
An insight into pharmaceutical careers for doctors.
Additionally, the ABPI careers site has further careers information and resources for pharmaceutical physicians in both the
Pharmaceutical careers for doctors and
Working in the Industry sections.
Qualifications for Pharmaceutical Physicians
To join the pharmaceutical industry as a pharmaceutical physician, you must be licensed with the General Medical Council (GMC). A GMC license is also required for specialty training through the Pharmaceutical Medicine Specialty Training programme (PMST), which provides a route to obtaining a Certificate of Completion of Training (CCT), and entry to the GMC's Specialist Register in Pharmaceutical Medicine. In order to qualify for a CCT through PMST, a physician must have also completed a period of clinical training, following qualification in medicine. For more information on the PMST please visit the Faculty of Pharmaceutical Medicine's
For more information on the entry qualifications and training required of pharmaceutical physicians, please see the ABPI's brochure, An insight into pharmaceutical careers for doctors.
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Working across multiple medical, regulatory, compliance and drug safety disciplines.