How Clinical Cancer Trials Work in the UK

Henry Kitchener, University of ManchesterANZGOG March 2013

Background The NHS has a vast budget which requires

evidence to define standards of care

The UK government understands this and is really committed to evidence based medicine

NICE defines standards of care with national guidance

This may be misconstrued as ”rationalising” but funding does require evidence of cost effectiveness.

Background UK has a prominent history of clinical trials.

The public have a supportive view and understand the importance of trials.

There is adequate funding for trials.

There is enthusiasm amongst clinical investigators.

UK is therefore fertile soil for clinical trials.

Source of funding gynaecological cancer trials CRUK

Funds Phase II and III trials through CTAAC. 20-25 new trials per year, across all cancer. Focus is on survival outcomes.

NIHR HTA Funds mainly Phase III trials across all of clinical

medicine. For cancer, focuses more on screening, quality

of life, and prevention outcomes. Commercial

Pharma sponsored studies and investigator led studies which a public body sponsors.

Funding model Direct costs; salaries & oncosts

Indirect costs; admin & estates charges

Consumables; essential materials

Service support; additional investigations over standard of care

“Excess treatment” costs; cost of the intervention if it were adopted after the trial. This also applies to screening.

Funding model

Charities Treasury Pharma Health “Authoritiy”

Direct costs

Indirect costs

Consumables

Service support

(sponsored)

Local Research Network

Excess treatment costs

Trial funding Trials funded by the Treasury, the AMRC

and “approved” investigator led Pharma trials are put on the National Portfolio.

National Portfolio trials qualify for support of research nurses. Funded through NCRN

Trust obtain public R&D funding for recruiting to clinical trials.

Trial costs

“Full economic costs” are part of the funding model of Universities

CRUK up to £100K/year to cover direct costs

NIHR HTA typically fund more complex trials which with FEC are £300-500K per year.

Clinical trials in the UK UK “suffers” from heavy regulation and

hurdles to overcome. Despite this trials are seen as the most direct

route to influencing standard of care. Can underpin a successful career “Impact” is increasingly the gold standard for

effective R&Dbut

Trials do require considerable determination and motivation.

InterGroup Trials Funders do understand the need for

international participation.

The GCIG is respected beyond the Gynae Cancer community.

Funding is available for trials led from ANZGOG as well as from the UK; recent examples

PARAGON (ANZGOG)

IP Chemotherapy (NCIC)

The Future Need to reduce bureaucracy

Targeted therapy

Biomarker led interventions (personalised medicine)

More complex trial design

More expensive trials

Molecular pathology (GCLP)

Biobanking