Clinical drug trials from a university hospital's point of view. Aki Lindén, CEO, Helsinki University Hospital

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1 Clinical drug trials from a university hospital's point of view Aki Lindén, CEO, Helsinki University Hospital

2 National Responsibilities and Special Areas university hospital districts: HUCH - Helsinki University Central Hospital KUH - Kuopio University Hospital TUH - Tampere University Hospital TUCH - Turku University Hospital OUH - Oulu University Hospital These are divided into hospital districts, 20 altogether in Finland. TUCH TUH HUCH OUH KUH Helsinki Besides its own area, HUS has responsibilities in specialized medical care also in the Etelä-Karjala (Eksote) and Kymenlaakso (Carea) hospital districts. Kotka Lappeenran ta

3 HUS Hospital Areas and Hospitals 2014 HUS is a municipal federation owned by 24 Uusimaa area municipalities. Hospitals belonging to HUS number 21. Lohja Hospital Paloniemi Hospital Hanko Lohja Hospital Area Raasepori Lohja Hyvinkää Hospital Area Hyvinkää Hospital Karkkila Länsi-Uusimaa Länsi-Uusimaa Hospital 5/7/2015 Hospital Area 3 Vihti Espoo Hyvinkää Vantaa Kauniainen Siuntio Helsinki Kirkkonummi Inkoo Jorvi Hospital Tammiharju Hospital Kellokoski Hospital Mäntsälä Järvenpää Askola Loviisa Nurmijärvi Pornainen Tuusula Kerava Porvoo HUCH Hospital Area Sipoo Peijas Hospital HUCH Hospitals in the Helsinki Area Lapinjärvi Porvoo Hospital Porvoo Hospital Area

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7 PATIENTS surgical procedures deliveries outpatient visits individual patients in specialised medical care Source: HUS, Annual Report 2014

8 employees 23 hospitals 2753 patient beds Annual turnover over million 15 % 85 %

9 Importance of research work in patient care Increased knowledge an accomplished researcher is a top expert in their field Views of the HUS medical care staff 91.4% believe research work has improved the professional skills of staff 87.4% believe research work has improved the efficacy of medical care 82.6% believe research work has improved the profitability of the operations (Karma et al., Duodecim 2014; 130: )

10 Importance of research work in patient care New information 81.5% of HUS researchers reported that their research work had led to several changes in clinical operations (approx. 700 individual changes in 11 years) e.g. major improvements in the treatment of asthma, introducing pneumococcal vaccine to prevent otitis, early diagnosis and intervention in alcohol addiction, improvements in prostate cancer diagnostics, prevention of oral infections in cancer patients, finding interactions between new medicinal products, prevention of waking up during general anaesthesia, characterising and establishing diagnostic criteria for several diseases caused by disturbances in mitochondrial metabolism. (Karma et al., Duodecim 2014; 130: )

11 HUS strategy for Principles and guidelines for research work in HUS The status of research work as one of HUS's basic duties is acknowledged in the entire organisation and the member municipalities. HUS hospitals and other units focus on the type of research work which, when successful, leads to ground breaking new information and consequently to improved diagnostics and treatment of different diseases.

12 HUS strategy for Cooperation with other organisations and the industry Our aim is to develop the scientific cooperation with the industry and to strengthen the status of HUS as a clinical trial location. Research work sponsored by a third party is subject to the same independent ethical reviews as any other research project.

13 Aspects of clinical trials in hospital operations Pros: improved staff skills carefully prepared trial protocols advanced quality management systems access to new medications years before general release free medications saving HUS approx. 15 million euros a year Cons: increased costs even when direct costs are reimbursed possibility of conflicts satisfaction of the researchers' intellectual needs not always guaranteed The pros outweigh the cons. Institutions compete for the best clinical trials, and they also attract the patients' interest. Funding cannot depend on the industry alone.

14 HUCH Comprehensive Cancer Center, homepage Ongoing research projects HUCS Department of Oncology conducts research on a broad scale, to promote the treatment of cancer and develop medication. All ongoing trials welcome volunteers as participants. An updated list of research projects is available on the Nordic NECTwebsite. If you are interested and want to know more about the ongoing trials, please contact the ward head nurse, tel

15 HUCH Comprehensive Cancer Center, homepage Cancer Title of research Title in Finnish Testicular cancer Detection of primary metastasis of the retroperitoneum in testicular germ cell tumours: comparison between CT and MRI Kivessyövän ensimmäisten vatsaonteloetäpesäkkeiden havaitseminen seurannassa kahdella erilaisella kuvantamismenetelmällä vertailu tietokonekerroskuvauksen (TT) ja magneettitutkimuksen (MRI) välillä Prostate cancer A Bioavailability Study of ODM- 201 Formulation with a Safety and Tolerability Extension Component in Subjects with Metastatic Chemotherapy- Naive Castration-Resistant Prostate Cancer ARAFOR OMD-201- tutkimuslääkkeen eri valmistemuotojen imeytymis- ja turvallisuustutkimus etäpesäkkeistä, kastraatiooon reagoimatonta eturauhassyöpää sairastavilla potilailla, jotka eivät ole saaneet solunsalpaajahoitoa (faasi I tutkimus) + 34 other research projects

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