1.10 Research to Clinical Practice Flashcards
Give 3 things required to ensure the safety and efficacy of new therapies and treatments
-collaboration between scientists and clinicians
-time
-money
What is the first step in developing a new treatment/therapy
First step is basic research surrounding the diseases, looking for proteins, genes and systems that contribute to development or progression of the disease
What is the second step in developing a new treatment/therapy
Second step is the pre-clinical trial. a pilot study to find potential effects and side effects, needs to show that results ‘translate’ into helping patients with the condition
What is required to move from pre-clinical trials to clinical trials
Lots of money and moving from a research lab to a hospital
What is the third step in developing a new treatment/therapy, describe its 3 stages
Clinical trials
Phase 1- 20-50 patients, uncontrolled study, mostly testing safety
Phase 2- 100-500 patients, randomised control study with placebo group, testing safety and efficectiveness compared to current treatments
Phase 3- 1000-5000 patients, randomised control double blind study, testing safety and effectiveness in a wide variety of people
What happens once a treatment passes all 3 phases
It can then be reviewed and approved by a regulatory body
Describe the development of vagal nerve stimulation as a therapy for heart failure
Research revealed that vagus nerve activity is lower in heart failure patients, hence vagus nerve stimulation (VNS) proposed as a therapy (vagus nerve stimulator and telemetry device and a week later, treatment starts and lasts for 6 weeks). It was found to improve survival rates in rats. In VNS there was a 6 month follow up from treatment where quality of life scores were measured (subjective) and heart function using ultra sound (objective).
There was little effect on heart function, but improvements in quality of life and in 6 minute walking test. Some side effects (hoarseness and neck pain). However with the clinical trials for VNS, there were conflicting results and reports of side effects. Alternatives were considered, what if you could stimulate the vagus nerve non invasively.
What is the review a treatment has to undergo after passing a clinical trial
A regular systematic review
Why is publication essential in the development of new treatments and therapies
For communicating findings to other scientists and to promote peer review to assess validity, quality and originality of the study. The reviewers are experts in the same field and the process is anonymous
