Transcript defused regular title for the presentation

Stakeholders In Clinical
Research
Other Funding Bodies
Professor Phil Warner
Other Funding Bodies
• We have seen that industry and
governmental healthcare agencies are
major funders and regulators of clinical
research
• Who else funds clinical research?
Who Else Funds?
• In the UK there are many other funders
• Non-governmental government funded
bodies e.g. the research Councils
• Charities
• The latter are often disease specific and
not all fund trials directly though they may
do this by supporting individual
researchers
• Let’s take a look at a couple of examples
Research Council Funding
• Research councils largely funded by
government but independent of it
• They fund research and equipment
• They also may fund the fabric i.e. buildings
of their units
• Work in partnership with Universities and
their funders (in the U.K hefce)
• Must be seen to serve their community
Who are the Research
Community
• Other researchers; proposals are “peer
reviewed”
• Government; research Councils keep an
eye on priorities
• Those within the Universities and industry
with whom the Research Councils work in
partnership
• The Medical Research Council’s
Clinical Trials Unit is one of the UK’s
leading centres for clinical research.
• The bulk of the CTU's work is designing,
developing and running clinical trials to
find better ways to prevent, diagnose, or
treat major health problems, in particular
cancer and HIV/AIDS.
• It also has a remit to expand into other
areas that do not have a strong tradition of
trials, for example arthritis, respiratory
disease and blood transfusion.
• Increasingly, CTU trials are looking beyond
whether a treatment is effective to see how it
affects patients' quality of life.
• This is important where small improvements in
survival come at the expense of unpleasant or
toxic side effects, in end-of-life care and where
quality of life is the only difference between
treatments
• The Unit also evaluates worldwide data
from other trials in systematic reviews and
meta analyses.
• Assessing whether treatments are cost
effective is another important
consideration, and the CTU collaborates in
this area with the Centre for Health
Economics at the University of York.
• While the Unit's core activities and many
of its trials are MRC-funded, contributions
to individual studies also come from the
NHS, UK government departments,
overseas governments, international
agencies, charities, and the
pharmaceutical industry
• Teamwork is crucial to every aspect of the CTU's work.
Its staff of over 100 includes epidemiologists, clinicians,
public health specialists, statisticians and other
scientists, health economists, trials and data managers,
IT specialists and administrators.
• Furthermore, their success hinges on the cooperation of
a wider external community: researchers, doctors and
nurses, funding bodies, policymakers and most
importantly patients and the public, without whom there
could be no trials.
• While the Unit's core activities and many
of its trials are MRC-funded, contributions
to individual studies also come from the
NHS, UK government departments,
overseas governments, international
agencies, charities, and the
pharmaceutical industry.
• The Unit is becoming increasingly involved
in collaborations with industry to develop
new drugs in situations where, for
example, very large trials are needed, or in
uncommon diseases that are not viable
commercial propositions. Industrial
support, often in the form of free drugs, is
also common in CTU trials of untried drug
combinations or new uses for existing
drugs.
• But most of the CTU's work is in areas of
little or no interest to industry
– for example, trials of generic drugs,
surgery, radiotherapy and new
technologies. All CTU trials retain scientific
independence and are overseen by
external data-monitoring committees
Charities
• Charities are an important source of
funding for clinical research
• They expect those with the disease and
donors to see real benefit form what they
do.
• BCRF has established a leadership role in
breast cancer clinical trials. In 2005, BCRF
created the Translational Breast Cancer
Research Consortium (TBCRC)
(coordinated by Nancy Davidson, MD, and
Antonio Wolff, MD, Johns Hopkins
University, Baltimore, MD), uniting the
efforts of 14 leading breast cancer
research centres in the United States.
• The Breast Cancer Research Foundation
is an independent 501 (c) (3) not-for-profit
organization whose mission is to achieve
prevention and a cure for breast cancer in
our lifetime by providing critical funding for
innovative clinical and translational
research at leading medical centers
worldwide, and increasing public
awareness about good breast health.
• In 2010, the American Cancer Society
estimates that about 207.090 new cases
of invasive breast cancer will be
diagnosed among women in the United
States, and that 40,230 women will die
from the disease.
• At this time there are about 2.5 million
breast cancer survivors in the United
States. Breast cancer is the second
leading cause of cancer death in women,
exceeded only by lung cancer.
• In men, 1,970 new cases are projected in
2010, with 390 deaths.
• The Consortium's mission is to reduce the
burden of breast cancer by using a
collaborative and multidisciplinary
approach to improve the understanding of
breast cancer biology and test new
therapeutic strategies. This is a savvy
method of extending the value of the field's
financial and intellectual resources
• In three years, TBCRC members have
completed a study of chemotherapy and a
biological agent, cetuximab, for "triple
negative" breast cancer, the kind of breast
cancer that cannot be treated by current
biological agents like endocrine therapy
• This is an example of a U.S charity
• Studies examining new combinations of
new biological therapies targeting the
oestrogen receptor and the HER2 proteins
have begun.
• Also, work to identify new markers in the
blood that might aid in breast cancer
management is underway.
Other Funders
• We have had a look at two examples of
other funding bodies.
• There are many more to look at;
• Examples
• National Cancer Institute (U.S)
• Heart research UK (translational and
training grants)
• Funding in India?