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Clinician Perspective Research Trials

Dr. Jim Crowley, MD, FRCPI, an interventional cardiologist at UCHG, discusses the advantages of clinical trials for hospitals and patients. These include exposure to the latest technology, enhanced institutional reputation, and economic benefits. His team, with experience from renowned institutions like the Mayo Clinic and Cleveland Clinic, emphasizes the importance of a strong training curriculum and high-quality clinical facilities. By aligning trials with institutional strengths, fostering collaborations, and addressing industry needs efficiently, they optimize outcomes and ensure timely completion of research projects.

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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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