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Clinician Perspective Research Trials

Clinician Perspective Research Trials. Dr. Jim Crowley, MD, FRCPI Interventional Cardiologist, UCHG. Advantages to Hospital/HSE. Patient exposure to latest technology Enhanced reputation of the institution Economic advantage to hospital. Expertise.

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Clinician Perspective Research Trials

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  1. Clinician PerspectiveResearch Trials Dr. Jim Crowley, MD, FRCPI Interventional Cardiologist, UCHG

  2. Advantages to Hospital/HSE • Patient exposure to latest technology • Enhanced reputation of the institution • Economic advantage to hospital

  3. Expertise • All have worked in “world class” institutions in Europe and the US • Mayo Clinic, Cleveland Clinic, DUMC, Thorax centre, Paris, Toulouse, Bern • The training curriculum strongly encourages experience abroad • 6 years: at least 2 abroad

  4. Expertise • Multicentre clinical device trials • PMA animal trials • Many have carried trials from concept to execution • All are high volume operators • PCI workload is 200+ per operator per year • Open to collaborations • Clinical facilities are high quality and most centres have the latest imaging modalities for performing modern research • Angio/QCA, IVUS, OCT, Pressure wire, Rotablator, TOE etc.

  5. Centre selection • There is now great awareness of need for completion to targets • Not to overload with similar trials • Align trials with the strengths of the institution • Recognition of the needs of industry to complete trials within a predicted time

  6. Feedback • We usually receive little feedback when not selected for inclusion in a trial • Frequently reasons for noninclusion can be easily rectified • Charge for ethics review; delays to approval; • Awareness of the general criteria help us to recognise the requirements of industry • Centre selection at an early stage

  7. Awareness of the issues • Industry deadlines • Time to ethical approval • Adequate volume of enrolees per centre • Commitment to targets within a time frame • “Clean data” • Appropriateness of patients enrolled • Minimisation of loss to follow-up • Timely reporting of adverse outcomes

  8. Responses to Industry • ICRIN and clinical trials liaison officer • Clinical research facilities • Parallel competent authority and ethics approval • Expert regulator • Changes in perception within the HSE

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