1. Clinical research in Sweden Current state and prospective Olle Stendahl, MD, PhD Dept. Molecular and Clinical Medicine Faculty of Health Sciences Linköping University

2. Clinical vs basic medical research ”Nothing is more demanding, more difficult, more frustrating, more time-consuming, and requires more creativity than clinical research” (Vaitukaitis, NIH) ”Basic scientists have to bake bread with clinicians and population biologists”(D. Nathan, Harvard)

3. Why is translational and clinical research in focus? Quality and development in health care - EBM Global health challanges A new generation of clinical investigators is needed Recruitment is weak MD/PhD students are ”old” New drugs are needed in certain areas A good investment for industry and society The public is interested, informed & demanding

4. Penicillin (1941) Cortisone (1949) Smoking identified as the cause of lung ca (1950) TB cured with streptomycin and PAS (1950) Polio epidemics and birth of intensive care (1952) Chlorpromazine for treating schizophrenia (1952) Polio vaccination (1955) Open-heart surgery (1955) Charnley’s hip replacement (1961) Kidney transplantation (1963) Cure of childhood cancer (1971) First test-tube baby (1978) Helicobacter as the cause of peptic ulcer (1984)

5. ”He was the first person from the clinical world who’d ever wanted to see my work” ”…suggested he see the crackpot down- stairs who’s trying to prove bacteria cause gastritis” Robin Warren & Barry Marshall Nobel laurates 2005

6. Characteristics of medical research Genes-function-disease-treatment Multidisciplinary Integration between basic, preclinical and clinical science Large clinical materials and trials Expensive infrastructures Biobanks and records

7. Exceptional returns One billion SEK in cardiovascular research has lead to reduced mortality worth >100 billion SEK 55 mUS$ in cancer research increased survival from testicular cancer (>90%)

8. Medical Research is a good investment Losec18,5 billion Nexium24 billion Seloken9 billion Pulmicort7 billion DialysisGambro

9. Global health challanges Global infections - HIV, malaria, TBC, SARS, Avian Flu… Diabetes Cardiovascul ar disease Cancer Psyciatric diseases

10. MD&PhD vs PhD 19881992199620002004 50% 100%

11. MD&PhD vs PhD 1000 500 300 200 100 Total PhD exams MD&PhD exams 1998200020012004

12. Academic physicians, MD,PhD MD%Docent% University hopsital5828 Regional hospital164 Private clinics3225 General practise152 (Sjukhusläkaren 4/2004)

13. What about the new generation? 1000 500 32% 2,5% PhD students accepted 2004 Total PhD MD Med. Stud.

14. Conclusions Fewer postgraduate medical students Fewer clinical investigators and they are too old (>45) 50% of clinical professors (>400) will retire in 5 years

15. Why do we lack clinical investigators? Clinical work takes too much time No career in sight - no tenure track Clinical science is not in demand Underdeveloped research milieus Weak infrastructure Lack of good projects and leaders Lack of funds for clinical trials

16. Funding for medical research 1993-2006

17. Funding for clinical research - 5 billion SEK

18. Funding of clinical research by industry in Sweden 2.5 billion SEK 5.0 billion SEK 2001 2003 2005 Internal costs External costs

19. Clinical research faces problems in several countries. US, UK and Canada have taken new initiatives Also Sweden must take actions….…

20. NIH 45% of the budget (26.9 billion) US$ is allocated to clinical and applied medical research

21. Does Europe have a future in biomedical research? Tom McKillop 1990199520002002 30 20 10 Pharmaceutical R&D (billion€) Europa USA

22. Why are we loosing ground? Lack of investment in health care Regulatory barriers Health-care systems and doctors are resistant to innovation Lack of clinical scientists University hospitals are no research hospitals

23. Clinical trials Clinical trials in Sweden have decreased: 464 (2004) 394 (2005) 4 Billion US$ 93 97 03 07 12 8 Clinical contractors Global revenues

24. The prospects to do clinical research are favourable in Sweden Good medical education Good basic research High quality health care National records and biobanks Strong biomedical industry Trust and support from patients

25. But Clinical research also requires … Strong research milieus Translational teams Research integrated as part of medical education Regional, national and international collaboration Infrastructure Long-term funding

26. …and Careers and insentives for clinical investigators

27. It should be more rewarding for a doctor’s career (and healhcare) to have a PhD in medicine than an MBA

28. Strategies and possibilities Integrate research in graduate and postgraduate education, and in the clinical work Make both academic and hospital leaders responsible for research Establish research careers and tenure tracks Build translational research teams and clinical research centers Develop national records and biobanks Improve the university hospitals as the most important infrastructure Create a national platform for clinical trials Form a Swedish ”NIH”- ”Research Council for Health”