How Clinical Cancer Trials Work
in the UK
Henry Kitchener, University of Manchester
ANZGOG 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




NIHR HTA



Funds Phase II and III trials through CTAAC.
20-25 new trials per year, across all cancer.
Focus is on survival outcomes.
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
Direct costs
Charities
Treasury
Pharma







Indirect costs
Consumables

Service support
Excess
treatment costs
 (sponsored)


Health
“Authoritiy”
Local Research
Network
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&D
but
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