Sharp Fall in Cancer Clinical Trial Recruitment

Peter Russell

December 09, 2021

Recruitment to cancer clinical trials in England fell by 59% during the first year of the pandemic, according to experts.

The Institute of Cancer Research (ICR) said COVID-19 had exacerbated long-standing issues with trial funding, regulation, and access.

With thousands of patients being excluded from the latest treatment options, the situation would delay development of cutting-edge drugs and technologies, it says.

The report,  Clinical Trials in Cancer , warns that huge opportunities could be missed to drive improvements in patient outcomes unless action is taken to open clinical trials more widely and at an earlier stage of treatment.

It says that investment is needed to overcome the effects of the pandemic as well as measures to reduce bureaucracy and regulatory barriers.

Recruitment into clinical trials dropped to 27,734 in 2020-21 compared with an average of 67,057 over the three previous financial years, the briefing found, using figures obtained from the National Institute for Health Research.

The reduction affected every type of cancer analysed, the ICR said.

Cancer Trial Access 'A Longer-term Problem'

However, even before COVID, recruitment was found to have varied significantly by cancer subspecialty.

Between financial years 2017-18 and 2020-21, the highest recruitment was seen in trials for breast cancer, lung cancer, and colorectal cancer; the lowest was seen in brain cancer and sarcoma.

Oncologist Prof Nick James, who led the study, said that as the pandemic took hold, "the barriers that were there before got worse, the bureaucracies for setting up got more difficult, priorities changed, rightly early on, but I would argue less rightly now, given that far more people die of cancer than die of COVID".

He told a briefing hosted by the Science Media Centre that "given that cancer is actually a bigger public health problem than COVID still, we would argue that investment in cancer trials is good for the country, and it's good for cancer patients in particular".

Red Tape and a Postcode Lottery

The study, carried out between April and July 2020, during the early part of the pandemic, identified several issues, including:

  • An excessive administrative burden in setting up clinical trials, especially for innovative trial designs such as biomarker-driven studies for precision medicine

  • A lack of systems in place in the NHS for rapid genetic testing of patients to select them for precision medicine trials

  • A 'postcode lottery' for patients in accessing the latest trials, with funding for doctors to carry out clinical research varying between hospitals

  • Inadequate information about clinical trials for patients and doctors

The ICR also asked the Picker institute, which focuses on high quality person-centred care, to ask 12 leading clinical investigators across the UK to identify barriers that might be limiting the pace and accessibility of clinical trials.

They cited a number of obstacles, including sourcing funding, the administrative burden, increasing cost and complexity of precision oncology, and difficulties in gaining regulatory approval.

One trial clinician told Picker that "The amount of regulatory hurdles you have to go through is huge, it’s slow".

Another supported wider access, saying: "I honestly think that there should be a trial for every single patient, and that’s what we should be aiming for."

Lack of Patient Awareness

The ICR also commissioned a YouGov survey of 505 adults who had been treated for cancer, which was carried out in April last year.

It found that 95% of respondents believed it was important that cancer patients were offered access to treatment in clinical trials. However, only 11% had participated in a trial during their treatment.

Patient information was also an issue, with just 37% of those surveyed saying they were aware of trials while they were receiving treatment.

The report makes a number of recommendations to improve the situation. These include:

  • Urgent investment in cancer clinical trial recovery post pandemic

  • Learning from COVID to streamline regulations

  • Making trials available earlier in treatment

  • More accessible trial information

  • Addressing the postcode lottery in access

  • Tackling access barriers for poorer patients and those from ethnic minorities

Prof James, a specialist in prostate and bladder cancer at the ICR, said that the biomedical response to developing COVID vaccines had been "spectacular" and demonstrated that "with the right political will and funding you can remove the barriers to set up trials, to running trials, and to running trials on a very large scale across multiple centres".

Prof Udai Banerji, deputy director of the Drug Development Unit at the ICR, commented: "We need streamlined and accelerated approval of promising drugs using novel trial designs.

"Clinical trials of drugs should be embedded into all aspects of cancer medicine from prevention, curative or non-curative therapy, to palliative care.

"The pandemic has caused us to pause and identify areas we can do better. It's time to make up for lost time."

Comments

3090D553-9492-4563-8681-AD288FA52ACE
Comments on Medscape are moderated and should be professional in tone and on topic. You must declare any conflicts of interest related to your comments and responses. Please see our Commenting Guide for further information. We reserve the right to remove posts at our sole discretion.

processing....