Consultant physicians working with patients - Royal College of ...

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2 Specialties Pharmaceutical medicinePharmaceutical medicineBen Cottam Policy and communications coordinator, Faculty of PharmaceuticalMedicine, London1 Description of the specialtyPharmaceutical medicine is a medical specialtyconcerned with the discovery and development,evaluation, licensing and monitoring of medicinalproducts, for the benefit of patients and public health.Pharmaceutical physicians work in the pharmaceuticalindustry, drug regulatory authorities, contract researchorganisations and academia. They have a close affinitywith their medical colleagues in primary and secondaryhealthcare.Pharmaceutical medicine is based on the knowledgeand understanding of how medicines work, thelimitations and variability of response to treatments,and how therapies can be used optimally in clinicalpractice. In addition to expertise in basic research,medicines development and evaluation, clinical trialsand registration, pharmaceutical physicians also need agood understanding of pharmacoeconomics, medicalaspects of the marketing of medicines, businessadministration and the social impact of healthcare onpatients and public health.The roles of pharmaceutical physiciansSome pharmaceutical physicians are involved indefining the biological mechanisms of disease, enablingmedicines to be identified that specifically target theillness. However, the majority of doctors in the specialtyare responsible for the design, management andimplementation of clinical trials and work with a teamof clinical investigators and supporting clinical staff.Theyareeitherdirectlyemployedbyindustry,orworkas independent consultants. Their work contributes toall stages of clinical trials as described below: A small number of pharmaceutical physicians areinvolved in phase 1 trials, which are conducted indedicated clinical pharmacology units and involvethefirstdosingofadrugto(usuallyhealthy)humans for safety and tolerability testing,measurement of pharmacological effects andpharmacokinetic profiling. Depending upon thetreatment indication and the type of drug beingevaluated, phase I studies may also be performed inpatients, eg in oncology studies. A larger number of physicians are involved in phase2 and 3 trials. Phase 2 trials are generally the firstconducted in patients and are small-scale trials thatgive an indication that the drug works effectivelyand safely. Pharmaceutical physicians choosesuitable disease targets, and design trials usingappropriate measures of clinical efficacy,pharmacodynamic endpoints and safety. Phase 3 trials are of larger scale, involving hundredsor thousands of patients and are required to provethe clinical efficacy and safety of a drug. Due to thepatient numbers required and the internationalnature of many pharmaceutical companies, phase 3trials are often carried out globally, requiringpharmaceutical physicians to adapt their practicesignificantly depending on location andcircumstance. Pharmaceutical physicians also consult on theimplementation of phase 4 clinical studies. Once amarketing authorisation for a new medicine isgranted and the drug opened to a wider patientgroup, post-marketing and continued safeprescribing needs to be closely monitored. Clinicaldoctors and pharmacists work closely with thepharmaceutical physicians responsible for drugsafety to ensure full, timely and complete analysis ofunexpected adverse drug reactions alongside theregulatory agencies, to comply with their necessaryreporting regulations.All trials are strictly governed by regulations designed toprotect the safety of patients. Many pharmaceuticalphysicians work within the regulatory agencies, such asthe Medicines and Healthcare products RegulatoryAgency (MHRA) and the European Medicines Agency(EMA), to ensure that trials are being carried out to thehighest ethical and safety standards and in the bestinterests of the patient. 1,2Some physicians are involved in medical affairs, whichincludes the marketing of medicinal products. Thesedoctors conduct market support studies, provideC○ Royal College of Physicians 2013 199
Consultant physicians working with patientsmedical input to marketing strategy, support sales staffin the field, review drug advertising and the safety(pharmacovigilance) of marketed drugs, and ensurethat the information materials for both prescribers andpatients are as accurate and easy to understand aspossible.Pharmaceutical physicians and patientsAs mentioned previously, those participating in clinicaltrials are usually either patients suffering with theparticular condition under investigation, or can behealthy members of the public who volunteer (and canreceive remuneration) to take part in trials. However,apart from phase 1 clinical trials, direct patient contactis rare for pharmaceutical physicians. Phase 1 trials arecarried out in independent ‘clinical research units’ andhere the pharmaceutical physicians have medicalresponsibility for the safety of the participants and musthave up-to-date knowledge of resuscitation techniquesand treatment of medical emergencies. These physiciansregularly conduct physical examinations for fitness, takeblood, give injections etc. Phase 2 and 3 trials areusually carried out with patients ‘in-the-field’ andpharmaceutical physicians are more involved inmonitoring the overall safety of patients, rather thanday-to-day contact. All clinical trials require theinformed consent of the participants andpharmaceutical physicians will be involved indeveloping the requisite consent forms. Pharmaceuticalphysicians who work for regulatory agencies havealmost no direct patient contact.Despite the fact that pharmaceutical doctors have verylittle direct patient contact compared with typicalhospital doctors or GPs, the medicines and vaccines thatthey develop can ultimately affect the lives of millions ofpeople across the world. Thus, working for the benefitof the public is still very much at the heart of apharmaceutical physician’s endeavours. Despite this,relations between the pharmaceutical industry, the NHSand patients are often strained. The report in 2009 bythe Royal College of Physicians (RCP) Innovating forhealth: patients, physicians, the pharmaceutical industryand the NHS 3 suggested that many patients remainconcerned that they do not enjoy equal access tomedicines, nor do they believe that the full range ofinnovative medicines that are available is brought totheir attention, thus undermining their confidence inthe entire prescribing process. The report also indicatedthat patients in the UK are usually very willing toparticipate in clinical trials but that patients report alack of opportunity. The working party that producedthis report is now coordinating the activities that willaddress these issues.Areas of workPharmaceutical physicians are involved in studiesconcerned with the research and development of newmedicines in almost all disease areas and will havespecialist knowledge in their chosen field of research.There are globally about 5,000 medicines and about350 vaccines currently in development (although only asmall percentage of these will successfully make it tomarket), with the majority of research efforts beingdirected towards new treatments for cancers, heartdisease and stroke, diseases of the central nervoussystem and tackling the burden of infection indeveloping countries (source: CMR International).2 Organisation of the service and patternsof referralAs the majority of pharmaceutical physicians workoutside the NHS and in such a wide variety of roles it isimpossible to crystallise how the service that theyprovide is organised. Pharmaceutical physicians are tobe found at all levels of service in commercial, academicand government institutions.Pharmaceutical physicians do not operate in thestandard referral channels of GPs and hospital doctors.Although they are involved in designing the protocol forpatient selection etc, they are not involved in individualpatient referral to a site conducting a clinical trial.3 Working with patients: patient-centredcareAs mentioned previously, very few pharmaceuticalphysicians have direct contact with patients, thoughtheir work is always for the benefits of patients and thepublic.Although the pharmaceutical physician does not deliverthe information regarding trials directly to the patient,they are involved in coordinating all the relevantinformation concerning the patient’s participation;including why the trial is being carried out, why thispatient is involved, and what the potential or expectedbenefits and risks are. One of the main sources ofinformation for clinical trials patients is the NHSwebsite ‘Involve’ 4 which is managed by the National200 C○ Royal College of Physicians 2013
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AbbreviationsA&EAACsAMUsARCPCCGsCCS
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1 Physicians in the NHS todaycan be
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2 Specialties Clinical geneticsClin
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2 Specialties HaematologyHaematolog
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