CLINICAL RESEARCH IN IRELANDDeirdre Hyland, RGN, RM, MScRCSI Clinical Research Centre

RCSI Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

Outline

Types of Clinical Research Where does it happen? Who does it? Clinical Research Infrastructure Taking Part in Research Regulations and Guidelines

What is Clinical Research?

Clinical research is research that either directly involves a particular person or group of people, or uses materials or data from humans, such as their behaviour or samples of their tissue, that can be

linked to a particular living person. https://

www.nichd.nih.gov/health/clinicalresearch/Pages/index.aspx

Why is Clinical Research Important?

Pharmaceutical Industry in IrelandIreland is one of the leading locations for the pharmaceutical

industry in Europe 100+ pharmaceutical companies including 9 of the 10 largest in

the world 40 FDA approved pharma and biopharma plants Wide range of products and services, from research and development

for new medicines to the manufacturing and marketing of new medicines for humans and animals.

Ireland is now the largest net exporter of pharmaceuticals in the EU accounting for over 50% of all exports

The sector employs over 24,500 people directly with an equivalent number employed providing associated services

Medical Devices Sector in Ireland

In Europe more than 575,000 people are employed in over 22,500 Medtech companies with an annual turnover of €110 billion

18 of the world's top 25 Medtech companies are located in IrelandEmploy more than 27,000During the recent economic crisis, the Medtech industry

continued to expand and experienced 7% export growth reaching €8.5 billion

Medtech accounts for 9% of all Irish exports

Types of Clinical Research

Patient-oriented research: Involves a particular person or group of people or uses materials from humans. Mechanisms of human disease Studies of treatments or interventions for disease Studies to develop new technology related to disease Clinical trials

Epidemiological and behavioural studies: Looking at incidence/ distribution of disease, factors affecting health, and how people make health-related decisions.

Outcomes and health services research: To identify the most effective and efficient interventions, treatments, and services.

What is a Clinical Trial?

A clinical trial is any research study that prospectively assigns human participants or groups of humans to one or more health-related interventions to evaluate the effects on health outcomes.

Include drugs, medical devices, medical or surgical procedures, radiological procedures, behavioural treatments, etc.

Who Plans/Funds Research in Ireland?

‘Other’ ResearchResearch Grants

HRB, SFI, EI, EU etc.Disease Groups & Medical Research Charity GroupsAcademic Institutions

Drug and Device TrialsPharmaceutical and Medical Device IndustryResearch GrantsAcademic InstitutionsClinicians

Do Patients have a Voice?

WHERE DOES IT HAPPEN?

Why Patients Take Part in ResearchParticipating in research can have perceived benefits for pts: Access to experimental treatments that might give better

outcomes than standard treatment Closer monitoring Increased access to members of healthcare team Extra investigations Altruism – genuinely want to help other people Vital that patient is aware of experimental nature of research

What you should know Who is organising and funding the study Has it been ethically approved? Why it is being done & why you are being asked

to take part What will happen to you Your responsibilities Risks and/or benefits That it’s ok to say no & that you can change your

mind at any time How your data will be protected No jargon & all questions answered

Enter subtitle here (24pt, Arial Regular)Enter date: 25.06.13

RCSI Royal College of Surgeons in Ireland Coláiste Ríoga na Máinleá in Éirinn

Research Ethics and Regulations

Mistakes and Scandals

The broad range of regulations, principles

and standards of good practice that

exist to achieve, and continuously

improve, research quality across all

aspects of healthcare

Legislation

Guidelines

Research Governance

#WHYWEDORESEARCH

Thank

you!