This session is a basic introduction to cancer treatments and their most common side effects and adverse reactions. The course provides an overview on cancer surgery, radiotherapy and chemotherapy we well as insights on the mechanisms of action of targeted therapies such as monoclonal antibodies, small inhibitory molecules, CAR-T cell therapy and immune checkpoint inhibitors.

In the second part of the session, participants will learn about the mechanisms of toxicity linked to the different categories of cancer therapy and how these are managed.

This course is not recommended for clinicians.

This course runs from 10:00am until 13.00pm.

1-day, in-person course

CPD Accredited (6 CPD hours)

Aims:

Health-related quality of life (QoL) is an essential outcome in contemporary clinical trials. This course will provide an overview of QoL assessment in oncology, including selecting appropriate QoL instruments and implementing, analysing, and interpreting QoL data across trial phases (I–III) and real-world studies.

The course will also cover incorporating QoL into grant applications and protocols, and its use in decision-making to support the implementation of new interventions into clinical practice (e.g. surgery or radiotherapy) or for market authorisation and market access of new cancer drugs. Sessions will be interactive and based on real-life examples.

Target Audience:

This course is for researchers, clinicians, healthcare professionals and statisticians from universities, pharmaceutical companies, NHS, and regulatory and health technology assessment agencies. No prior knowledge of quality of life is required.

The course will run between 09:30-17:00.

This session gives a comprehensive overview of the clinical pathways cancer patients can take to be eventually referred for trial entry. The first part of the session spans across the diagnostic methods and staging of cancer and gives a brief overview of the common tests carried out prior to trial treatment.

In the second part of the session participants will learn about the importance of ensuring only eligible patients enter a trial and how eligibility criteria help to safeguard patients and differ amongst different phases of trials. They will also learn the importance of assessing treatment compliance and how every clinical intervention comes with a different set of challenges in collecting data about patient compliance.

Patient Information Sheets (PIS) are a key document for potential participants to make an informed decision about whether to take part in a clinical study.  While there is clear guidance from the Health Research Authority (HRA) on content and regulatory requirements, PIS are customised for each clinical trial and the specific patient population. Choosing the right language and format for patient facing materials for research studies and clinical trials still greatly varies and depends on the skills and experience of the team putting them together.

In this workshop attendees will gain valuable insights how to improve the format, language and delivery of the PIS working with clinical trial professionals and, patient and public representatives.

The workshop includes:

an overview of the HRA guidance on the PIS design,

an introduction to writing in plain English and accessibility

a patient perspective

group work in breakout rooms with trial professionals and patient and public representatives to review a draft PIS

Preparation: Review a draft PIS before the workshop (up to 1 hour preparation time).

After the course, attendees will receive a “PIS Checklist”: a summary of top tips when designing a Patient Information Sheet.

This session, aimed at non-statisticians, will cover the most common primary outcomes measures used in early and late phase cancer trials.

Learning Outcomes:

Participants will learn what makes a good outcome measure, how outcomes measures are defined and what data need to be collected to assess the outcome, especially for tumour response assessment and time to event measures such as survival and disease (or progression) free survival.

This course runs from 10:00am until 13.00pm

This session provides a general introduction to cancer clinical trials for staff new to academic cancer studies.

Participants will get an overview on what clinical trials are and how they can have a preventative, curative or palliative aim. The session covers the practical and scientific reasons why we need clinical trials, what are the differences between Phase I, II, II and IV studies and the different methods of randomization. The session also highlights how drug development trials in cancer differ from non-cancer studies and how the new era of targeted therapy and immunotherapy is changing the way cancer trials are designed. 

Please note that the course will run between 10.00am until 13.00pm.