Pierre Lafolie MD, PhD Senior Consultant, Clinical Pharmacology, Karolinska University Hospital Solna, Stockholm Senior Reader, Associate professor,

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1 Pierre Lafolie MD, PhD Senior Consultant, Clinical Pharmacology, Karolinska University Hospital Solna, Stockholm Senior Reader, Associate professor, Dep of Medicine - Solna, Karolinska Institutet, Stockholm Scientific Secretary, Research Ethical Review Board, Stockholm

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4 Sites marked * are University hospitals Luleå Umeå * Göteborg* Falun and Borlänge Stockholm* and Uppsala* Linköping* and Örebro* Kalmar Malmö* and Lund*

5 Phase-1 unit Need for authorisation by Competent Authority Sometimes connected to a specific therapeutic area Emergency Care Unit needed near-by Specific therapeutic field Connected to a clinic Eg. oncology, orthopedic, dementia, pediatric General Often connected to a phase-1 unit when located at a hospital Open Care Trial Unit No beds needed

6 Clinics/Hospital departments Clinical research centers S3 Clinical Research Centers, Stockholm Blekinge kompetenscentrum, Karlskrona Centrum för klinisk forskning Västmanland, Västerås Centrum för klinisk prövning, Sahlgrenska Universitetssjukhuset, Göteborg Clinical Research Support, Örebro Forskningsenheten, Ersta Sjukhus, Stockholm Gothia Forum, Sahlgrenska Universitetssjukhuset, Göteborg Karolinska Trial Alliance, Stockholms Läns Landsting, Stockholm Kliniskt forskningscentrum, Norrlands Universitetssjukhus, Umeå LARC, Universitetsjukhuset Linköping, Linköping Region Skånes Kompetenscentrum för Klinisk forskning, Skånes Universitetssjukhus, Lund SLL Innovation, Stockholms Läns Landsting, Danderyd Smärtspecialistmottagningen, Stockholm Uppsala Clinical Research Centre, Akademiska Sjukhuset, Uppsala FoU-enheten, Norrbottens Läns Landsting, Luleå FoU-enheten, Karolinska Universitetssjukhuset, Stockholm Gastrocentrum, Karolinska Universitetssjukhuset, Stockholm Hjärtkliniken, Karolinska Universitetssjukhuset, Stockholm Infektionskliniken, Karolinska Universitetssjukhuset, Stockholm Instutitionen för klinisk neurovetenskap, Karolinska Institutet, Stockholm Kardiologkliniken, Falu Lasarett, Falun Kliniken för Endokrinologi, Karolinska Universitetssjukhuset, Stockholm Kliniken för Plastikkirurgi, Karolinska Universitetssjukhuset, Stockholm Klinisk Farmakologi, Karolinska Universitetssjukhuset, Stockholm Klinisk Farmakologisk Prövningsenhet, Karolinska Universitetssjukhuset, Stockholm KPE Onkologiska Kliniken, Radiumhemmet, Karolinska Universitetssjukhuset, Stockholm Kvinnokliniken, Karolinska Universitetssjukhuset, Stockholm Medicintekniskt centrum Novum, Karolinska Universitetssjukhuset,Stockholm Neurologiska kliniken, Akademiska Sjukhuset, Uppsala Onkologiskt Centrum, Lunds Universitetssjukhus Ortopedkliniken, Länssjukhuset i Kalmar, Kalmar Reumatologiska kliniken, Sahlgrenska Universitetssjukhuset, Göteborg Transplantationskirurgi, Karolinska Universitetssjukhuset, Stockholm

7 Baseline SOPs Adequate premises with relevant equipment Relevant professions Competent staff with expertise and up-dated training including GCP Social and financial skill Extra Outstanding portfolio, preferably publiced Documented agency inspections Documented audits

8 Drug trials New chemical entities, new indications, orphan drugs Medical Devices Mostly in class 1B, 2A and 2B Nutrition Medical nutrition, food additive s Advise One dedicated CTU in the country SME s and young researchers often need a general CTU to discuss protocol, statistics and how-to-do-it

9 Feasibility How many patients are available How many will participate How to approach them Time to approval CA, Ethics, and other (eg. radiation committee), amendments Hospital resources Availability of doctors,nurses and technical staff Eg. probability to have an endpoint x-ray in dedicated time window No referals Project forgotten by collegues?

10 Do drugs, nutrition and medical devices All phases 1-4 Have some smaller funding to support academic s Is expected to meet its own cost Organised as company owned by the university or the hospital an in-house department Baseline staff backed up with consultants

11 Focused on attracting studies (income) Is also contracting partner for all other commercial studies at the hospital One-stop-shop Have established prices for services and algorithms for preparing bids Have an established financial system for transparency of incoming payments

12 - How are commercial clinical research financed in your country? State assistance? Only by industry? Are there staff made available for commercial clinical trials in hospitals? What type: CRT, clinical research nurses, investigators? Do they receive trainings? Who finance these professionals? Are investigators certified to practise clinical research in your country? Is there a PCB training frame of reference? What is the process for hospital contracts signature? A unique contract for all the implicated centers or a center per center contract? - Do industry sponsors have performance criteria provided in order to measure their commercial clinical trials? - At a national level, at a centers scale? - How is feasibility done? - Process in the centers, response time? - Are privileged partnership between industry sponsors and investigation centers/hospitals possible? - Are there clinical investigation networks connecting hospitals and doctor offices (outside of hospitals) in your country? - How are they organised?

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