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