Randomised clinical trials
Randomised clinical trials are trials where the people being studied are randomly allocated one or other of the different treatments under investigation. This trial design allows the effectiveness and/or side effects of the different treatments to be compared and are often considered the gold standard in trial methodology.
Large Phase III randomised trials are required to show that a new treatment is more effective, less toxic or less expensive than the current standard of care and they are used to change practice across the country. These trials often have the current standard of care as one of the treatment arms in the study. There may be several test arms studied in the same trial e.g. MRC STAMPEDE trial
Smaller Phase II randomised trials are increasingly being conducted, in which investigators are comparing the effectiveness of two or more new treatments, to decide which is best to take forward into a Phase III trial. In addition to the main question, both Phase II and Phase III randomized clinical trials can provide additional scientific information. In particular, doctors and scientists may be able to identify which subset of patients is most likely to benefit from a new treatment.
This work package will focus on collaborative working between research partners including patients and the public. It will develop, support and deliver improved randomised clinical cancer trials in Wales and beyond. The research will focus on radiotherapy and translating lab science to bedside medicine.
It will continue the development of innovative trials methodology and progress existing clinical trials at Phase I into the next stages. The work package hopes to improve cure rates, minimise long term side effects of treatment and address the economics of healthcare delivery.
For further information please see the Cancer Research UK website.
Dr John Staffurth
In Cardiff, radiotherapy related research is a key component of our approach to improving outcomes of people with cancer. It is one of the strategic priorities of the recent Cardiff University – Velindre NHS Trust Memorandum of Understanding.
The main themes of our research are:
1. Clinical trials
- Velindre-based clinical oncologists have led several clinical trials involving radiotherapy over recent years including PR07, SCOPE1 and NEOSCOPE.
- Velindre has recruited hundreds of patients over many years to ground-breaking clinical trials involving radiotherapy over recent years including CHHiP, ProtecT and SCALOP.
- Velindre hopes to start recruiting patients from across Wales in early phase trials combining radiotherapy with novel drugs, targeting cancer resistance mechanisms to radiation-induced cell death
- The Wales Cancer Trials Unit has run a portfolio of trials with radiotherapy as its main focus of interest: SCALOP, SCOPE1, NEOSCOPE, SCOPE2, I-START, ROCS, PATHOS.
2. Radiotherapy trials quality assurance (RTTQA) – Velindre is one of four National RTTQA centres in the UK, ensuring that the radiotherapy within clinical trials is delivered to the very highest quality. Our main area of interest in chemo-radiotherapy trials in gastrointestinal cancers.
3. Radiotherapy physics research
- Cardiff University researchers are developing methodologies to improve the accuracy of individualized molecular radiotherapy (injected radiotherapy) using functional imaging modalities such as PET scans.
- Cardiff University researchers in collaboration with Velindre are developing award-winning methodologies to improve the accuracy and consistency of radiotherapy using functional imaging modalities such as PET scans.
- Cardiff University researchers in collaboration with Velindre are developing methodologies to analysis the routine CT and PETs used to predict the outcome of radiotherapy: ‘Textural analysis’.