Pierre Lafolie MD, PhD Senior Consultant, Clinical

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
Sites marked * are University hospitals
Umeå *
Falun and Borlänge
Stockholm* and Uppsala*
Linköping* and Örebro*
Malmö* and Lund*
 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
Clinics/Hospital departments
 Clinical research centers
S3 Clinical Research Centers, Stockholm
Blekinge kompetenscentrum, Karlskrona
Centrum för klinisk forskning Västmanland,
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,
Region Skånes Kompetenscentrum för Klinisk
forskning, Skånes Universitetssjukhus, Lund
SLL Innovation, Stockholms Läns Landsting,
Smärtspecialistmottagningen, Stockholm
Uppsala Clinical Research Centre,
Akademiska Sjukhuset , Uppsala
FoU-enheten, Norrbottens Läns Landsting, Luleå
FoU-enheten, Karolinska Universitetssjukhuset,
Gastrocentrum, Karolinska Universitetssjukhuset,
Hjärtkliniken, Karolinska Universitetssjukhuset,
Infektionskliniken, Karolinska Universitetssjukhuset,
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,
Klinisk Farmakologisk Prövningsenhet, Karolinska
Universitetssjukhuset, Stockholm
KPE Onkologiska Kliniken, Radiumhemmet, Karolinska
Universitetssjukhuset, Stockholm
Kvinnokliniken, Karolinska Universitetssjukhuset,
Medicintekniskt centrum Novum, Karolinska
Neurologiska kliniken, Akademiska Sjukhuset, Uppsala
Onkologiskt Centrum, Lunds Universitetssjukhus
Ortopedkliniken, Länssjukhuset i Kalmar, Kalmar
Reumatologiska kliniken, Sahlgrenska
Universitetssjukhuset, Göteborg
Transplantationskirurgi, Karolinska
Universitetssjukhuset, Stockholm
 Baseline
 SOPs
 Adequate premises with relevant equipment
 Relevant professions
 Competent staff with expertise and up-dated training including
 Social and financial skill
 Outstanding portfolio, preferably publiced
 Documented agency inspections
 Documented audits
 Drug trials
 New chemical entities, new indications, orphan drugs
 Medical Devices
 Mostly in class 1B, 2A and 2B
 Nutrition
 Medical nutrition, food additive’s
 One dedicated CTU in the country
 Advise
 SME’s and young researchers often need a general CTU to discuss
protocol, statistics and ”how-to-do-it”
 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?
 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
 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
 - 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
 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?
 [email protected]