Investigator-initiated Clinical Trials (IICTs)
Targeted support for academic clinical studies
Clinical researchers pose patient-relevant scientific questions and initiate sponsor-independent clinical trials, thus making an important contribution to medical development.
We support such investigator-initiated clinical trials (IICTs) from conception to publication with a comprehensive range of experts from different disciplines providing consulting and service offers. For applications to the corresponding funding program from the Swiss National Science Foundation (SNSF), we provide assistance gained through many years of experience.
Reference projects
OxyTUTION
Oxytocin substitution therapy in patients with central diabetes insipidus: a double-blind randomized-controlled trial the OxyTUTION trial
Direction
Prof. Dr. med. Mirjam Christ-Crain, Dr. med. Cihan Atila, Dr. med. Svenja Leibniz, Prof. Dr. med. Dominique de Quervain, Prof. Dr. med. Matthias Liechti
Study design
Randomised, placebo-controlled, double-blind phase II study
Study objective
To investigate the effects of intranasally administered oxytocin on psychological symptoms and socio-emotional deficits in patients with diabetes insipidus
Number of planned study sites
4-5
Number of study participants
112
Project duration
2023-2028
DKF support
Methodological consulting, Consulting on Patient & Public Involvement (PPI), Statistics, Data Management, Monitoring
Funding
SNF-IICT
EMINENT-ICH
Early Minimally INvasive image-guided ENdoscopic evacuaTion of IntraCerebral Haemorrhage: a randomized controlled trial
Direction
PD Dr. med. Jehuda Soleman, Prof. Dr. med. Raphael Guzman, Dr. med. Tim Hallenberger
Study design
Randomised-controlled, non-blinded superiority trial
Study objective
To evaluate the efficacy of early minimally invasive surgical hematoma evacuation in patients with intracerebral hemorrhage
Number of planned study sites
11
Number of study participants
200
Project duration
2023-2028
DKF support
Methodological consulting, Consulting on Patient & Public Involvement (PPI), Statistics, Data Science, Monitoring
Funding
SNF-IICT
PFOA II
Treatment of patellofemoral osteoarthritis with nasal chondrocyte-based engineered cartilage(N-TEC) implantation in a randomized, controlled, multi-center phase II clinical trial
Direction
Prof. Dr. Ivan Martin, PD Dr. med. Marcus Mumme, Prof. Dr. Andrea Barbero
Study design
Prospective randomised-controlled phase II study
Study objective
To investigate the efficacy of treatment of patellofemoral osteoarthritis (PFOA) with nasal chondrocyte-engineered cartilage (N-TEC)
Number of planned study sites
7
Number of study participants
75
Project duration
2023-2028
DKF support
Methodological consulting, Statistics, Data Management, Monitoring
Funding
SNF-IICT
Treatment of lymphedema after breast cancer-therapy
Registration number
pending
Principal Investigators
Research group E. Kappos, Oncology & Hematology and
M. Katapodi, Clinical Epidemiology, Public Health & Health Systems
DKF support
Methodology, Patient and Public Involvement (PPI), Statistics, Regulatory Affairs, Project Management, Data Management, Data Science, Monitoring
Funding
SNF IICT
ESTREL
Parkinson drug «Levodopa» for motoric regeneration after stroke
Registration number
NCT03735901
Principal Investigator
Research group S. Engelter, Neurology
DKF support
Methodological Consulting, Statistics, Project Management, Data Managament, Data Science, Monitoring
Funding
SNF IICT
MultiSCRIPT
Optimised care for MS patients
Registration number
pending
Principal Investigator
Research Group Ö. Yaldizli, Neurology
DKF support
Methodology, Patient and Public Involvement (PPI), Statistics, Regulatory Affairs, Project Management, Data Management, Data Science, Monitoring
Funding
SNF IICT
HIT
Correction of the electrolyte balance
Registration number
NCT03557957
Principal Investigator
Research Group M. Christ-Crain, Endocrinology, Metabolism and Developmental Disorders
DKF support
Methodological Consulting, Statistics, Data Management, Monitoring
Funding
SNF IICT
DISTAL
Endovascular therapy for stroke
Registration number
NCT05029414
Principal investigators
Research group M. Psychogios, Neurology, and U. Fischer, Neurology
DKF support
Methodology, Statistics, Regulatory Affairs, Data Management, Project Management, Monitoring
Funding
SNF IICT
PREPEC
Quality of life through breast reconstruction with implants after mastectomy
Registration number
NCT04293146
Principal Investigator
Research group W.P. Weber, Breast Centre University Hospital Basel
DKF support
Methodological Consulting, Regulatory Affairs, Data Managament, On Site Management, Monitoring
Funding
SNF IICT
OSPIC
General practitioner study for the therapy of subacute postinfectious cough
Registration number
NCT04232449
Principal investigator
Research group A. Zeller, Immunology & Infectiology
DKF support
Methodological Consulting, Statistics, Regulatory Affairs, Projekt Management, Data Management, On Site Management, Monitoring
Funding
SNF IICT
BaseTIL
Personalized approach in immunotherapy against skin cancer
Registration number
NCT04165967
Principal investigator
Research group H. Läubli, Oncology & Haematology
DKF support
Statistics, Regulatory Affairs, Project Managament, Data Managament, Data Science, Monitoring
Funding
Innovation Grant USB
SECA
Blood thinner for chronic subdural hematoma
Registration number
NCT03120182
Principal Investigator
Research group J. Solemann, Neurology
DKF support
Statistics, Data Management, Monitoring
Funding
SNF project funding
MechSens
In vivo mechanosensitivity of joint cartilage
Registration number
NCT04128566
Principal Investigator
Research group A. Mündermann, Regenerative Medicine & Biomechanics
DKF support
Methodological Consulting, Statistics, Regulatoriy Affairs
Funding
SNF project funding
RECUT
Outpatient steroid treatment of COPD patients with acute exacerbation
Registration number
NCT02386735
Principal investigator
Research group J. Leuppi, Intensive care & Pneumology
DKF support
Statistics, Regulatory Affairs, Data Management, Monitoring
Funding
SNF project funding
CARLO®
Medical technology innovation from Basel: Robot-assisted laser surgery
Registration number
NCT03901209
Principal Investigator
Research group A. Müller, Regenerative Medicine & Biomechanics
DKF support
Statistics, Regulatory Affairs, Data Management, On Site Management, Monitoring
Funding
AOT
KIDS-STEP
Corticosteroids for the treatment of severe pneumonia in children
Registration number
NCT03474991
Principal Investigator
Research group J. van den Anker, Klinische Pharmakologie
DKF support
Methodological Consulting, Statistics, Regulatory Affairs, Data Management, Monitoring
Funding
SNF IICT
Processing of emotions
Neural correlates in social behavior disorders or autism
Registration number
NCT04324099
Prinicipal Investigator
Research group C. Stadler, Psychiatry
DKF support
Methodological Consulting, Statistics, Regulatoriy Affairs
Funding
SNF project funding
APRESCALP
PDE4 inhibitor Apremilast in psoriasis of the scalp
Registration number
NCT03553433
Principal Investigator
Research group A. Navarini, Immunology & Infectiology
DKF support
Methodolocical Consulting, Statistics, Regulatory Affairs, Data Mangement, On Site Management, Monitoring
Funding
Cellgene
CoSIP
Copeptin-based test for the differential diagnosis of diabetes insipidus
Registration number
NCT00757276
Principal Investigator
Research group M. Christ-Crain, Endocrinology, Metabolism & Developmental Disorders
DKF support
Statistics, Data Management, Monitoring
Funding
SNF project funding