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

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2 Specialties Pharmaceutical medicineInstitute for Health Research (NIHR). Many <strong>of</strong> thedisease-specific charities also provide advice andinformation for <strong>patients</strong> who are already undergoingor thinking about becoming involved in clinicaltrials.The issue <strong>of</strong> post-trial patient information is consideredto be an integral part <strong>of</strong> patient rights and has beenmentioned as part <strong>of</strong> the World Medical Association’sDeclaration <strong>of</strong> Helsinki on the Ethical Principles forMedical Research Involving Human Subjects, 5 whereparagraph 33 states:At the conclusion <strong>of</strong> the study, <strong>patients</strong> entered intothe study are entitled to be informed about the outcome<strong>of</strong> the study and to share any benefits that resultfrom it.Despite this, <strong>patients</strong> are still not routinely kept up todate <strong>with</strong> the outcomes <strong>of</strong> trials that they have beeninvolved in. The main reason for this is that <strong>of</strong>ten manymonths or years have elapsed before the analysis <strong>of</strong> atrial is complete and the communication channelsbetween the investigators and <strong>patients</strong> and theirconsultants have <strong>of</strong>ten broken down. Clinical trialparticipants are coded and thus the responsiblepharmaceutical physician does not have access toindividual <strong>patients</strong>. At the end <strong>of</strong> the trial, the outcomesare reported to the investigators involved and it is theirresponsibility to pass this information on to theparticipants from their centre.4 Interspecialty and interdisciplinaryliaisonAlthough their contact is <strong>of</strong>ten limited, pharmaceutical<strong>physicians</strong> work <strong>with</strong> clinicians across almost the entirespectrum <strong>of</strong> medicine. They are available to talk toclinicians <strong>working</strong> in a particular field and to discuss theuse <strong>of</strong> medicines in a particular condition. Clinicaldoctors always have a route <strong>of</strong> contact <strong>with</strong> a company’smedical information department when issues aroundmedicinal products arise, and these circumstances arelikely to involve a pharmaceutical physician.Increasingly, pharmaceutical <strong>physicians</strong> are also actingas direct sources <strong>of</strong> expert information on the medicinesthat their companies provide to doctors <strong>working</strong> in theNHS. This interaction is usually initiated by theconsulting clinician and can act to greatly enhancepatient care but is currently an underusedrelationship.5 Delivering a high-quality serviceWhat is a high-quality service?Due to the diverse nature <strong>of</strong> their roles, it is difficulthere to define precisely what constitutes a high-qualityservice as delivered by pharmaceutical <strong>physicians</strong>.Beyond phase 1, the running <strong>of</strong> a safe and efficientclinical trial requires close collaboration <strong>of</strong> the trialsponsor, the hospital or clinic where the <strong>patients</strong> arelocated and the consultant or GP responsible for them,the chief investigator and other healthcare pr<strong>of</strong>essionalssupporting the research and the ethics committeeresponsible.To ensure a safe, rigorous and well-executed trial thesponsor or chief investigator must go through severalauthorisation procedures before, during or after aclinical trial:1 The sponsor or investigators must first apply to theMHRA for clinical trial authorisation (CTA). Theythen usually register the trial for an internationalstandard randomised controlled trials number(ISRCTN) and although this is not compulsory itensures that the trial complies <strong>with</strong> the requirements<strong>of</strong> the International Committee <strong>of</strong> Medical JournalEditors (ICMJE) – a prerequisite for publishing trialdata in most journals.2 Ethical approval for the trial must be sought by theprincipal investigator through a research ethicscommittee (REC), part <strong>of</strong> the National ResearchEthics Service (NRES).3 Once a trial is under way, safety and progressreporting must be carried out to the appropriateREC both on a periodic basis (both 6-monthlyand annually) and also whenever there is anunexpected or dangerous event, known as asuspected unexpected serious adverse reaction(SUSAR).4 When a trial is finished it must be reported to theMHRA and the relevant REC (<strong>with</strong>in 90 days <strong>of</strong> itsconclusion or <strong>with</strong>in 15 days <strong>of</strong> early termination)and a summary <strong>of</strong> the final report on the researchshould be sent to the main REC <strong>with</strong>in 12 months <strong>of</strong>the end <strong>of</strong> the project.Those pharmaceutical <strong>physicians</strong> who work for theregulatory agencies have a very different remit andtherefore different definitions <strong>of</strong> a quality service.Their prime responsibility is to protect publichealth.C○ <strong>Royal</strong> <strong>College</strong> <strong>of</strong> Physicians 2013 201

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