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Overview
Coronavirus notice - Essentials of Clinical Trials
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Course dates: 1 - 5 July 2024

The course will have a hybrid format and students can choose to attend in person in London or online.  Offer holders will be required to confirm before the course start date whether they are planning to attend online or in person.

LSHTM understands this is an uncertain time and rules around international travel could change at very short notice. We strongly advise candidates that choose to attend the course in person in London to only book refundable tickets and accommodation, and to ensure you have checked and comply with all UK entry requirements.

Overview - Clinical Trials
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This course gives attendees a clear understanding of the fundamental principles of Randomised Clinical Trials (RCTs).

Live lectures and practical sessions will cover the key issues in design, conduct, analysis and reporting, with a focus on major clinical trials that directly influence clinical practice. Topics are addressed with perspectives from both public sector research and the pharmaceutical industry.

Who should attend?

The course is relevant to anyone who'd like to get an understanding of the rigorous evaluation of interventions in health care, including clinical research professionals, research managers, statisticians and other scientists with an interest in clinical trials.

Teaching

The course is coordinated by Jennifer Nicholas, Matthew Dodd and Eni Balogun and taught by members of the Department of Medical Statistics who have extensive experience in the design, conduct and analysis of trials in a variety of clinical specialties.

Accreditation

The course has been approved by the UK Royal College of Physicians for 30 Continuing Professional Development (CPD) credits.

Course fee

The course fee for 2024 is £1,795.  

Fees cover participation in the course and access to the course materials, including videos and downloadable course notes.

Course objectives
Course objectives - Clinical Trials
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Course content

The topics to be covered will include:

  • Design of RCT: randomisation, blinding, trial size
  • Ethical conduct: participant consent, data monitoring and when to stop early
  • Certified Good Clinical Practice (GCP) training
  • Introduction to statistical methods for design and analysis
  • Alternative designs for clinical trials
  • Reporting: how to write, and critique, a clinical trial report
  • Clinical trials in practice
  • Practical experience in development of a clinical trial protocol.
    (Participants will work in small groups to develop and present trial protocols.)
  • Guest lecture

In addition to the formal teaching sessions, we will run two optional drop-in sessions on Wednesday and Thursday afternoon. Participants will be able to discuss specific questions about their own research with a member of staff from the Medical Statistics Department or the Clinical Trials Unit. We will provide forms for you to submit your questions ahead of the drop-in sessions.

Teaching format

Teaching will take place through a combination of live lectures and practical sessions, which can either be attended in person at LSHTM in London or online via videoconferencing using Zoom.

Each of the practical sessions are directly related to a lecture, and participants will be expected to attend the live lecture (in person or online) before the related practical. 

Live sessions will run each day of the course, and will take place between approximately 9.30am and 5pm British Summer Time (BST) with breaks for drinks and lunch. Participants who are taking part in the course online using Zoom will need to have a reliable internet service and a PC or laptop with microphone and speakers.

A Guest Lecture will be given by an invited speaker.

Course materials

The course materials include lecture videos which will be available to watch for 5 weeks as described above. Lecture notes and slides and practical handouts will be available to download and keep. All materials required for the course will be provided in advance. Practical solutions will be provided at the end of each practical.

The following are recommended as optional additional background materials:

  • Evans I, Thornton H, Chalmers I and Glasziou P. Testing Treatments: Better Research for Better Healthcare.  Pinter and Martin, 2011.
  • Friedman LM, Furberg CD, DeMets D, Reboussin DM, and Granger CB. Fundamentals of Clinical Trials. Springer, 2015
  • Pocock SJ. Clinical Trials: A Practical Approach. Wiley, 1983

Assessment

There is no formal assessment.

Accreditation

The course has been approved by the UK Royal College of Physicians for 30 Continuing Professional Development (CPD) credits.

Testimonials
Testimonials - Clinical Trials
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Comments by course participants

'Having the lectures online so you can watch (and re-watch) is really helpful and keeping the content available for a couple of weeks is great.'

'In my opinion it was very well structured and nicely tailored to its wide range of professionals attending the course'.

'The knowledge of the speakers was very good. You could see that most of them had real experience in the areas of these topics, which is good from a learning perspective'.

'There were opportunities to discuss ideas with peers'.

'GCP was enjoyable and useful and good to get certificate'.

‘The organisation was perfect and the interaction with the lecturers was fantastic’.

‘Practical sessions were very helpful and allowed the theory to become more understandable’.

‘Broad range of topics were covered – case studies are brilliant tools to consolidate knowledge'.

‘I enjoyed study design, data monitoring and the designing protocol and practical sessions. I do like data monitoring a lot and also liked the randomisation session’.

How to apply
How to apply - Clinical Trials
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Applying for the course

Applications are now closed. You can register your interest and we will let you know when applications reopen.

Please read LSHTM's Admissions policies prior to submitting your application.

Short courses - visas, accommodation, disclaimer
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Visas

The student is responsible for obtaining any visa or other permissions to attend the course, and is encouraged to start the application process as early as possible as obtaining a visa for the UK can sometimes take a long time. The Short Courses team can provide supporting documentation if requested.

Accommodation

A list of hotels located in the vicinity of LSHTM, along with further resources for short term accommodation, can be found on our accommodation pages

Important information

Please note:

  • Students will be required to bring their own laptops. The Stata package will be available for the duration of the course.
  • If you have been offered a place on the course you will not be able to register without bringing a formal ID (Passport) and without having obtained the correct visa if required.
  • It is essential that you read the current visa requirements for short course students.
  • LSHTM may cancel courses two weeks before the first day of the course if numbers prove insufficient. In those circumstances, course fees will be refunded.
  • LSHTM cannot accept responsibility for accommodation, travel and other losses incurred as a result of the course being cancelled.