MSc Clinical Research.
I would like to thank my sponsor, Health Education England, for supporting my studies. There is high demand for quality cost effective health care services. Knowledge and critical understanding of clinical research methods is important to professionals in the health, social care and private sectors, where evidence based approach, supported by academic rigour is very crucial to decision making, clinical practice and delivery of integrated services. Clinical research is essential in building the scientific foundation for clinical nursing practice; preventing disease and disability; managing and eliminating symptoms caused by illness; and enhancing end-of-life and palliative care.
The course comprises eight taught modules which provides a deeper understand knowledge and critical understanding of clinical research methods. This is important to professionals in the health, social care and private sectors, where an evidence based approach, supported by academic rigour is very crucial to decision making, clinical practice and delivery of integrated services. It included qualitative and quantitative research methods for the discovery process for medical interventions through exploration of experimental design and statistical interpretation, and by examining the national, and international regulations, guidelines, ethical requirements and research governance.
The individual project enables application of the knowledge gained during the taught phase to clinical practice. I have completed the following four modules.
- Transition of new medicinal products into the clinic.
Module Aim.
To provide an overview of translational medicine from a global, academic, commercial and public sector perspective.
Learning Outcomes
v Demonstrate a conceptual understanding of the scientific, commercial and public and private sector forces underpinning translational medicine research.
v Demonstrate a critical awareness of translational medicine approaches currently being adopted in academia and industry through real-life case-studies.
The assignment on Alzheimer’s disease enabled me to critically analyse publications, relating theory to practice.
- Research design and methodology.
Module Aim
To provide a systematic understanding of processes necessary to formulate, develop and test a scientific hypothesis
Learning Outcomes
v Develop a hypothesis for a novel research problem.
v Formulate aims and objectives as a route to solving a hypothesis.
v Identify appropriate funding sources for a project.
v Distinguish between and describe quantitative and qualitative research methods.
v Recognise and use appropriate data presentation techniques.
Assignment was developing a research proposal.
- Preclinical Evaluation in drug development.
Module Aim
To critically analyse the information generated by pre-clinical studies and its application in later stages of clinical development
Learning Outcomes
v Describe the range of evaluations required before clinical studies can commence.
v Critically appraise the strengths and weaknesses of pre-clinical studies in terms of ability to predict clinical results.
v Demonstrate critical evaluation of candidate molecules in terms of safety and efficacy by using case studies
The assignment was critically analysing the information from preclinical evaluation to determine safety and efficacy of the investigational drug.
- Clinical trial practice
Module Aim
To provide a detailed understanding of the expectations, methodologies, and end-points of the clinical evaluation process.
Learning Outcomes.
v Demonstrate a thorough understanding of the clinical evaluation process.
v Compare and contrast clinical evaluation of pharmaceuticals and devices.
v Design a clinical trial and justifying the rationale behind a particular design.
v Demonstrate an understanding of key considerations in clinical trial design such as recruitment/retention of participants, end-points and patient reported outcomes.
v Describe clinical data management.
The assignment was designing a clinical trial and developing a study protocol.
The Florence Nightingale Research Scholarship has provided me with the opportunity to pursue a career in clinical research. I am currently in my final year. The transferable skills which are; communication, networking, leadership, research management and dissemination skills will enable me to work with different research groups to improve patient care, ensure drugs and devices are safe for patient and staff use.