The importance of clinical trials

Clinical trials are vital in testing the effectiveness of potential new treatments and are a key step in the translation of laboratory research to patient benefit. Trials test whether a drug is safe (phase 1 trials), effective (phase 2) and whether it is better than current, standard treatments (phase 3). The evidence accumulated determines whether patients would benefit from a new treatment.

Clinical trials in the UK

The government’s National Institute for Health Research (NIHR) supports the infrastructure for developing and running clinical trials in England. Last year, the NIHR supported over 6,100 studies that recruited over 870,000 participants [1]. In 2018/19, over 67,000 patients took part in clinical studies for cancer research [2].

Earlier this year, in response to the challenges faced by the current pandemic, the NIHR announced that clinical trials would be suspended to prioritise the development of new COVID-19 studies and enable the redeployment of clinical staff to frontline care. Most trials that were recruiting patients to brain tumour studies and many others were put on hold.

Restarting clinical trials

Towards the end of May, the NIHR released guidance to support the restarting of clinical trials that were affected. The guidance provides advice to sponsors, recruitment sites and funders on how to decide whether a study should be restarted.

This is welcome news. Clinical trials are a crucial step to developing new treatments and offer hope to patients. However, significant effort and care will be required to return clinical trial activity to the levels seen at the start of this year. Furthermore, only 3% of patients with a brain tumour are able to join a clinical trial [3] - we want to see this figure increase substantially. This will require a major increase in the number of potential treatments being developed through the research pipeline.

Challenges lie ahead

We face challenging times ahead. Restarting clinical trials whilst maintaining social distancing to protect patients and clinicians will make trials more time consuming and costly. For example, there will be reduced access to key equipment, such as MRI scanners, which will need to be thoroughly cleaned between each patient as a precaution against disease spread. Clinical trial protocols will be re-assessed to minimise the time patients need to be in hospital and consider what information can be collected remotely.

The future funding of clinical trials is also a big concern. Charity funders such as Cancer Research UK, who support almost 50 per cent of all cancer research in the UK, has been forced to make £44m in cuts to its research spending as a result of the pandemic. They support a large number of clinical trials and it is worrying that fewer trials may be able to start in the future due to lack of funding.

Patients, the research community and funders like Brain Tumour Research are keen to see clinical trials running normally again. We want to see the innovative results from our Research Centres being translated into clinical trials and onwards to deliver benefits for patients. The restarting of clinical trials is an essential step on what was, even before COVID-19, a very challenging road towards finding cures for brain tumours.

Links / info:

[1] https://www.nihr.ac.uk/explore-nihr/support/clinical-research-network.htm
[2] https://www.nihr.ac.uk/news/record-number-of-patients-take-part-in-clinical-research/11746?diaryentryid=44785
[3] http://csg.ncri.org.uk/wp-content/uploads/2019/02/NCRI-Brain-Group-Annual-Report-2018-19.pdf see appendix 5; based on 5 year average from 2014/15 - 18/19

Related reading:

• Covid-19 impact on research could last a generation
• What is a clinical trial?