Randomized controlled trial in health sciences – why and how to run a high quality trial

Content of the course:
The randomized controlled trial (RCT) is considered as the most rigorous method of determining whether a cause-effect relationship exists between an intervention and outcome. The strength of the RCT lies in the process of randomization that is unique to this type of study design. There are a lot of important considerations before deciding on and initiating a RCT, which will be dealt with in the course.

Aim of the course:
The present course will cover topics on how to design and run a RCT in health sciences, different types of trial designs, sample size calculation, choice of outcome, bias, placebo effect and the publication procedure.

Form:
Lectures and group assignments

Course directors:
Søren Overgaard, Professor, Graduate Programme (FUP) director
Anders Holsgaard Larsen, Associate professor, Member of the FUP steering committee
Department of Clinical Research, OUH and SDU 

ECTS-credits: 2,5

Course Venue: Odense

Course fee:
The course is free of charge for PhD students enrolled in Universities that have joined the "Open market agreement".
For other participants there is a course fee of DKK 7606.2,-

Tentative Programme: 

 

Topic

Teacher

Notes

Monday 30th November

 

 

 

0915-0930

Welcome, introductions, course overview and goals

Anders Holsgaard Larsen

Søren Overgaard

 

0930-0945

Introduction of yourself (max 30 sec)

Participants

 

0945-1015

Research, historical perspective

Søren Overgaard

 

1015-1030

Coffee

 

 

1030-1115

So, you think you want to run a RCT?

 

Planning of the RCT study

 

Anders Holsgaard Larsen

- When and why is the RCT the right study design

-Level of evidence

-Pros and cons

-PREPARE

-CONSORT statement

-SPIRIT

1115-1215

Different study types in the clinic and different RCT types.

Anders Holsgaard Larsen

-Superiority/non-inferiority

-Explanatory/pragmatic trials

-Minimal clinical important difference

1215-1300

Lunch

 

 

1300-1400

How to get started with your RCT

Anders Holsgaard Larsen

-PREPARE

-Consider your design

-Which outcome

-Feasible

1400-1415

Coffee

 

 

1415-1530

Present your own study I

Short presentation of study (xx participants)

Students should prepare a 5 min pitch of their own study, irrespective of their study design

 

1530-1630

How and why to publish a study protocol

Erik Poulsen

The study protocol – at a glance

Tuesday 1st December

 

0830-0930

Bias in RCT

Robin Christensen

Different types of bias in RCT

0930-0945

Coffee

 

 

0945-1045

Study power calculation: participant with tensions, safety, monitoring board

Robin Christensen

 

1045-1100

Coffee

 

 

1100-1200

Statistical analysis plan, absolute / relative differences, number needed to treat

Robin Christensen

 

1200-1245

Lunch

 

 

1245-1300

Clinimetric evaluation of outcomes used in clinical trials

Henrik Lauridsen

Short overview of important measurement properties of trial outcomes

1300-1315

Project administration

Annie Gam

The role of a study nurse/study administrator

1315-1330

Clinical equipoise

Søren Overgaard

Definition and examples of equipoise

1330-1515

RCT-Café were participants can ask questions if relevant for their project

Henrik Lauridsen

Søren Overgaard

Annie Gam

Robin Christensen

 

-Clinimetric questions

-Clinical equipoise

-The role of a study nurse/study administrator

-Statistics in your trial

1515-1530

Coffee

 

 

1530-1630

Present your own study II

Short presentation of study (xx participants)

Students should prepare a 5 min pitch of their own study, irrespective of their study design

 


Wednesday 2nd December

 

0830-0930

Placebo definitions and effect

Surgery and placebo

Ian Harris (web lecture)

 

0930-1000

Coffee

 

 

1000-1100

The future of RCT

Ian Harris (web lecture)

Pros and cons of the RCT study

 

1100-1200

Challenges in the study of RCT, complex interventions and complex patients

Søren Skou

Lessons learned and good suggestions

1200-1300

Lunch

 

 

1300-1430

Present your next future study or how will knowledge from the course affect your current study

Søren Overgaard

Anders Holsgaard Larsen

 

1430-1500

Course summary, discussion and evaluation

Søren Overgaard

Anders Holsgaard Larsen