& IMMUNOLOGY

INFECTIOUS DISEASES

- LEARNING CENTER

- NETWORKS

- SCIENTISTS

- HIGHLIGHTED TRIALS

- OUR SOLUTION

- THE CHALLENGES

INFECTIOUS DISEASES AND IMMUNOLOGY

Infectious Diseases are a significant burden on public health and economic stability of societies all over the world. The threat posed by infectious diseases is deepened by the continued emergence of new, unrecognised pathogens and the re-emergence of old infectious diseases, creating a never-ending cycle. While the emergence of novel treatments will generate new opportunities, important challenges in clinical trials remain – from managing overall costs to maintaining strict operational oversight. There is also the challenge of patient recruitment – diagnosis of a disease often takes several days, but patients must be enrolled in a study within 24 hours, and some diseases are seasonally active, appearing and disappearing quickly.

THE CHALLENGES

Difficulty in finding appropriate patients due to large number of competing trials by many companies
Large study size – 31% of Phase III trials need 1000+ patients
Lengthy trials result in challenges for patient recruitment and retention
KOL / KOI needed to provide expert knowledge for defining actual endpoints – identification of the right lead investigator

OUR SOLUTION

Global Scientific Networks – ReSViNET, AfricaNET – enable access to more patients
Our multi-country Primary Care Research Network aids in patient recruitment and retention
Peer-to-peer Leadership model helps stimulate recruitment and share best practices
Our in-house Scientific Officers have extensive knowledge of current infectious disease treatment and trial methodology

HIGHLIGHTED TRIALS

2 TRIALS

1158 SITES

125000 PATIENTS

CAPiTA

58 Sites

85000 Patients

Finished

LLI

1100 Sites

40000 Patients

Finished

SCIENTIFIC OFFICERS

A key strength of Julius Clinical is the academic expertise and integrity of our scientific team. Our scientific leaders have broad experience on study committees and are able, through their contacts, to bring together and work effectively with international networks of thought leaders. Our scientific officers related to the therapeutic expertise Infectious diseases and Immunology, are:

PROF. MARC BONTEN

Professor of Molecular Epidemiology

Marc Bonten is Professor of Molecular Epidemiology of Infectious Diseases, and head of the department of Medical Microbiology, at the University Medical Center (UMC) Utrecht, the Netherlands.

PROF. LOUIS BONT

Paediatric Infectious Diseases Specialist

Louis Bont, MD, PhD, is Paediatric Infectious Diseases Specialist and Leader of the RSV Research Group at the University Medical Center Utrecht in Utrecht, The Netherlands.

PROF. PETER HERMANS

Professor in molecular infectious diseases

Peter Hermans is Professor in Molecular Infectious Diseases, appointed at Julius Centre for Health Sciences and Primary Care at University Medical Centre Utrecht (UMCU) and chairing the ‘U-TRIAL’ activities for UMCU’s priority field Infection & Immunity.

NETWORKS

Clinical Investigator Networks are a vital element in both academic and clinical research settings. Among peers in the scientific community, investigators communicate and collaborate directly, contributing to the advance of the study imperatives. For this reason, within the clinical research setting, advantages are gained when coordinated research networks are maintained and managed. Networks that are related to the therapeutic expertise Infectious diseases and Immunology, are:

ReSViNET is a global network of experts in the field of Respiratory Syncytial Virus (RSV) infections who are known to be skilled recruiters. Together, they have designed and completed a multitude of RSV trials. ReSViNET consist of 17 board members representing more than 100 trial sites in 13 countries. These sites are academic hospitals with many years of experience in clinical research, enabling fast and high quality recruitment and above average retention rate. RSV is a cyclical illness, and the ReSViNET global network ensures that trials can be conducted throughout the year, following the outbreak of the disease across continents and hemispheres. Because of this, the ReSViNET experts and investigator sites are located around the world, making it a truly international network.

We provide a model infusing scientific leadership, RSV knowledge and trial experience into various levels of complex clinical trials for the benefit of trial outcomes, offering academic leadership and leveraging our RSV knowledge and experience towards the site study team. We deliver our services both for clinical trials in pediatrics as well as trials in older adults.

Please visit the ReSViNET website if you would like to learn more about ReSViNET.

In sub-Saharan countries, access to health care is still a challenge, resulting in profound inequities in health in the region. Challenges to effective health services and interventions include geographical, physical financial and/or cultural barriers. Sub-Sahara has one of the highest neonatal and maternal mortality and morbidity rates in the world, almost 70% of all HIV/Aids cases can be found here. Clearly, then, support for the region is desperately needed.

Julius Clinical and Julius Global Health (part of the University Medical Center Utrecht) have joined together to create AfricaClinical, a network of local investigators and institutes who are committed to improving healthcare and the health of the sub-Saharan population.

The network consists of 40 local investigators from 20 countries with a trial network of over 100 sites. These investigators and sites have all many years of experience in research and performing clinical trials in the field of Infectious Diseases, Metabolic Diseases and Cardiovascular Diseases and have access to a substantial number of patients, enabling fast and high quality recruitment and retention rate.

We are involved in the European Developing Countries Clinical Trials Partnership (EDCTP) – TDR Clinical Research and Development Fellowship as a host organisation.