Clinical Trials

Question 1

Reasons for clinical trials

Answer 1

Safety
Efficacy
Regulatory approval 
Convince doctors 
Convince payers/accountants
Convince NICE 
Demonstrate risk reduction to investors 
Demonstrate success to current/future employees

Question 2

How do trials in the pharm industry work?

Answer 2

Very scripted, with little flexibility

Pre-clinical, Phase I-III

Question 3

Goals for trials for MD

Answer 3

Goal 1: safety
Goal 2: performance
Goal 3: efficacy

Question 4

What kind of trials are done for MDs?

Answer 4

Randomised control trials

Ofter with sham procedures, involving fake implantation/use of device

Question 5

Clinical protocol

Answer 5

PPE
Patient selection (clinical indication, acute v chronic, age, gender, Comorb)
Procedure (dose, duration,freq, training of clinicians)
Endpoints (primary and secondary, stat significance and power)

Question 6

Clinical trial checklist

Answer 6

PIT C’é

Protocol 
Investigators brochure 
Technical file 
Clinical trial application
Ethics committee submission

Question 7

Ardian case study

Answer 7

On the Lancet, it was reported that Ardian device (for renal denervation in refractory HTN) was successful with p value 0.0001.
Medtronic buys Ardian for 800 mil, and designs a large study for FDA approval (incl of sham study). It finds that Ardian is not effective.
First trial results were incorrect.
Refractory patients had not been taking medications regularly prior to study > this was why they got better doing the study. There was no difference between placebo and Ardian.