Collaborate to simplify cancer trials and accelerate post-pandemic recovery

How could simplifying the administration of clinical trials help cancer diagnosis, care, and treatment levels to exceed pre-pandemic levels? Amanda Barrell reports from the ABPI Scotland cancer roundtable discussion.

Work to get Scotland’s cancer services back to full strength following the pandemic has already begun, and the pharmaceutical industry has pledged to play its part.

A roundtable discussion, facilitated by ABPI Scotland and attended by stakeholders from across government, industry, patient groups, and the NHS generated a number of recommendations aimed at providing “policymakers with tangible actions for change”.

“COVID-19 has brought challenges to the way cancer treatments and clinical trials are delivered across Scotland and it is clear that collaboration will be required to ensure care returns to pre-pandemic levels,” said a report of the event.

“The pandemic has demonstrated the benefits of greater collaboration between industry, academia, the NHS and government and we believe this model should be adapted for the return of cancer services and other care. This new spirit of partnership has the ability to improve patient outcomes and create efficiencies for the NHS.”

Recovery and redesign

In December 2020, the Scottish Government published a National Cancer Plan, and while it listed a total of 68 actions, four were described as “flagships”.

These include a plan that each patient should have a single point of contact within the NHS throughout their cancer journey, and the introduction of a “prehabilitation” programme. This would include “multi-modal” wellbeing support ahead of treatment, to include topics such as nutrition and mental health.

The plan also mandates the setting up of Early Cancer Diagnostics Centres, with three NHS boards already being awarded funding, and the creation of the Scottish Cancer Network. These new groups, along with other entities such as the Cancer Clinical Trials Resilience Subgroup and the National Cancer Medicines Advisory Group, will be overseen by the Scottish Cancer Oversight Committee.

The biopharmaceutical industry, the roundtable report said, is keen to add value to this new structure wherever possible.

“COVID-19 has brought challenges to the way cancer treatments and clinical trials are delivered…and it is clear that collaboration will be required to ensure care returns to pre-pandemic levels.” 

Clinical research

One of the priorities of the National Cancer Plan is to not only restart, but improve the efficiency of, clinical trials.

“Clinical trial activity was almost totally halted during the first wave of the pandemic. Although the level of activity has not fully recovered, the level of demand for new studies is as high as ever.

“To allow clinical trials to restart, trial sponsors have accepted modifications to their protocols in terms of monitoring visits, remote/virtual consent and increased telephone/remote assessment,” said the roundtable report.

It goes on to make a number of recommendations as to how this recovery can be accelerated by focusing on the administration, reporting, certification, and governance of clinical trials.

It suggests, for example, replacing the site-by-site model of protocol approvals with regional or national ways of working, and recommends sponsors strive to make access to research more equitable.

“Regional or national models would allow patients to fluidly move between boards without extensive bureaucracy,” said the report, which also recommended a study be undertaken to assess the barriers and additional support needs for patients engaging in national or regional clinical trials.

In terms of reporting, clinical staff are “getting tired finding the time to do the extra work required to run a clinical trial on top of a busy clinical practice”, said the report. Simplified pro forma reporting systems, collating or pre-processing notifications, and minimising amendments once trials are up and running would all help ease the burden on staff.

The report also talks about the certification of laboratories and testing sites, which can add “needless duplication and delays” to research processes. “Sponsors should accept a model… where a single, credible professional survey is undertaken of a testing facility then shared and accepted by all parties, it said.

Adding value

Stakeholders across the healthcare ecosystem all want to see cancer care and trials return to pre-pandemic levels as soon as possible, and for patients to receive faster access to diagnostics and treatment, said the report.

“The Scottish Government’s Cancer Recovery plan will be a key document in taking this forward, but given it was penned during the middle of the pandemic second wave, there is a need to ensure policy is fluid and that changes are made as and when required,” it said.

Continual dialogue, and collaborative solutions are the key – not just in Scotland, but across the UK.

“From the discussion it was evident that there is a need to simplify processes for both the setup and administration of clinical trials, especially if research is truly to be open to all. The Scottish Government and the NHS will need to work together to simplify these processes to reduce the burden on clinicians and provide clarity for industry partners.

“Contributors were also clear that these solutions must be seen within the context of the soon to be released implementation plan for the UK Government’s clinical trial vision. This document, a landmark policy paper, commits all four nations to improving the landscape for clinical trials through the deployment of digital solutions and embedding research within care.”

Ultimately, there is a shared desire to “put patients at the heart of care and to make services easier to access and simpler to understand.”

“The pharmaceutical industry was clear in their desire to partner with the NHS and to offer solutions through collaborative working.

“The need to maintain dialogue and ensure that there are clear NHS points of contact will be critical to these efforts and we hope that this roundtable provides a starting point for future collaboration and discussion,” concluded the report.

About the author

Amanda Barrell is a freelance health and medical education journalist, editor and copywriter. She has worked on projects for pharma, charities and agencies, and has written extensively for patients, healthcare professionals and the general public.