Stakeholders In Clinical Research

1. Stakeholders In Clinical Research Other Funding Bodies Professor Phil Warner

2. 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?

3. 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

4. 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

5. 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

6. The Medical Research Council’s Clinical Trials Unit is one of the UK’s leading centres for clinical research. 

7. 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.

8. 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

9. 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.

10. 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

11. 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.

12. 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.

13. 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.

14. 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

15. 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.

16. 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.

17. 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.

18. 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.

19. 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.

20. 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

21. 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

22. 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.

23. 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?