Save the date: ICN - ZKS Symposium Clinical Trials in the Global and Digital Word, 27 September 2019 in Freiburg im Breisgau, Germany

The annual Symposium will take place on Friday 27th September 2019 in Freiburg, Germany, at the Auditorium Otto Krayer Haus.
The annual ICN Symposium is always a great opportunity to strengthen the relationship among ICN members and get to know our network colleagues in person.
Please save the date and come join us in September 2019! Deadline for registration is August 30, 2019.

ICN new service for investigators: Consulting for PI

ICN has created a joint service called “Consulting for Principal Investigators”. Participating ICN members offer a free preliminary consultation to Principal Investigators (PIs) intending to initiate an investigator initiated trial in an international setting. The consulting service will range from advice on trial feasibility, trial design to sample size.

The Karolinska Trial Alliance (KTA) is piloting a new service – Rent a Research Nurse

It is of central importance to have available research nurses when conducting clinical studies. However, in Sweden there is a shortage of research nurses which means that clinics may have to refuse clinical studies due to lack of resources. KTA has therefore started a pilot project where we rent out research nurses to increase the possibilities for clinics to start, conduct and participate in academic and industrial-funded clinical studies.
The overall goal is to offer flexible solutions for both shorter and longer assignments. KTA hopes that more clinics will be able to participate in clinical studies when the hired research nurse takes care of the study-related work. The pilot project will continue during 2019 and then be evaluated. KTA starts on a small scale with two rentable research nurses and a limited number of assignments in the Region of Stockholm.

HCTC GmbH is now the HCTC-KKS

The Hannover Clinical Trial Center (HCTC GmbH, Germany), was founded in 2005. It is a competent and reliable partner for scientific institutions and companies for all aspects for clinical research and development.
On 19th December 2019 HCTC GmbH was incorporated into the Hannover Medical School and is now the HCTC-KKS (Coordinating Center for Clinical Studies) at Hannover Medical School.

Kyoto Research Seeds

The Kyoto University Graduate School of Medicine and Kyoto University Hospital started some years ago a very ambitious project aiming at converting the findings of basic medicine and biology efficiently into novel clinical trials. This strategic project is being developed by the Institute for Advancement of clinical and Translational Science (iACT). A brochure with selected research projects was issued in 2017. Last year iACT looked worldwide for investigators interested in cooperating with their Japanese researchers for proof-of-concept projects.
At Zurich University Hospital (USZ, Switzerland) and through the Zurich CTC two potential matches (for the provided example and for an additional project) have been identified. In December 2018, Muneo Takatani, Akira Shimizu und Tsutomu Nishimura visited those potential partners in order to better precise possible terms for the potential collaborations.
We wish our Japanese colleagues all the success for this project!

International presence of Biobank Graz

Located in Graz, Austria, Biobank Graz is a non-profit oriented biobank of the Medical University of Graz and integrated in the university hospital clinics (LKH-Universitätsklinikum Graz). The biobank has been formally established in 2007 and is considered one the largest hospital-based biobanks in Europe harbouring millions of biological specimen and data (e.g. tissues and body fluids) collected throughout more than 3 decades. Internationally active, Biobank Graz participated recently at the “BioTech Pharma Summit” (February 2019, Porto) and “ISBER Symposium Focus on Quality and Standards” (February 2019, Berlin), during which lectures and posters were presented. Knowledge transfer in biobanking is one of the core values of Biobank Graz. In this context, several educational opportunities are offered for international biobankers and practitioners (short-term courses and master programs). The upcoming sessions can be found via https://biobank.medunigraz.at/education/.

IUKAMM launches INFLAMIST

Istanbul University Center of Excellence (IUKAMM) started an ambitious Turkish Research Council Project entitled INFLAMIST, investigating the inflammasome-mediated inflammation disease and, particularly, familiar Mediterranean fever. The ultimate goal is to produce high technology drugs and develop biomarkers to solve this important health issue in Turkey.

New Phase I Unit planned in Istanbul

The Istanbul Medical Faculty CTC, which is under the Department of Clinical Pharmacology, is expanding its activities. Beyond the in-house cardiovascular and hematology clinical trials, a patient phase I facility has been submitted to the Ministry of Health for accreditation in addition to the ILAM (Drug Research Center) of the University. In collaboration with the Mehmet Akif Cardiovascular Hospital, with has a 12-bed phase I unit, some specialized trials are starting. Thus, Istanbul CTC will soon have access to three phase I Units.

The DRINK Trial

Our ICN member Cambridge Clinical Trials Unit is proud to announce the successful completion of the DRINK trial. This was a randomised trial to test the feasibility of a large scale trial of high water intake on autosomal dominant polycystic kidney disease (ADPKD) progression. The study was led by the first ICN research fellow Dr Ragada El-Damanawi and funded by PKD Charity.
The study proved that patients with ADPKD were willing to be randomised, and that most patients were able to adhere sufficiently to a fluid prescription. The research team intends to conduct a large scale trial to assess the effectiveness of increased water intake on ADPKD progression. For more details, please visit: https://pkdcharity.org.uk/research/pkd-charity-research/progress-reports/348-adpkd-drink-trial

New leadership at Clinical Trials Center Zurich

The CTC Zurich was founded in 2006 by Prof Dr Gabriela Senti. Since then, the CTC Zurich collaborates with an impressive range of Swiss clinical trial institutions. Besides providing services to clinical researchers, the CTC focuses on a range of educational opportunities. In April 2019 Dr Regina Grossman succeed Gabriela in her role of Head of CTC Zurich.
Regina Grossman has a broad experience regarding clinical research. After working at the Swiss Health Authority as a GCP inspector and medical reviewer, she joined the University Hospital Zurich (USZ) 8 years ago. She has been involved in monitoring duties and the preparation of regulatory documents for FIM trials in academic research projects. In addition, she has been the Head of Quality Assurance and GCP-Auditor for the last 4 years. She is very enthusiastic about continuing the engagement of CTC Zurich with ICN.

HKU-CTC’s 20th Anniversary Ceremony & Gala Dinner

The University of Hong Kong Clinical Trials Centre (HKU-CTC)’s 20th Anniversary Ceremony and Gala Dinner was successfully held on 7th November, 2018. The event was the grand finale of a series of anniversary activities during 2018. Some 200 prominent officials, academia, healthcare practitioners, clinical research professionals and industrial representatives joined in reviewing HKU-CTC’s 20 years of ground-breaking journey in clinical research and gave their heartfelt greetings in Loke Yew Hall, a historic landmark of HKU.

Professor Karen Lam, Chairman of HKU-CTC, kick-started the ceremony by expressing her gratitude to all the stakeholders in clinical research during the welcoming address. The guests of honour, Professor Sophia Chan, Secretary for Food and Health of the HKSAR Government, and Professor Paul Tam, Provost and Deputy Vice-Chancellor of HKU, highlighted the importance of clinical research to healthcare and scientific advancement and congratulated HKU-CTC’s contributions to the Hong Kong society and worldwide over the past 20 years.

A highlight of the evening was the interactive and interesting panel discussion featured by five distinguished HKU clinical researchers who together reviewed the history of clinical research over the past decades and shared their insights on the future research trends and opportunities for Hong Kong. The society’s support is the key to the success of clinical research. The 3 performing groups showed their strong support to clinical research on behalf of different generations of Hong Kong people at the occasion. It was a delightful and fruitful evening.

A commemorative publication outlining HKU-CTC’s 20 years of development and achievements was also issued (available at https://www.hkuctc.com/documents/20theBook/index.html).

Design Thinking Workshop

On 12th November 2018 the “ICN corporate identity – Design Thinking Workshop” took place in Zurich. The goal of the workshop was to improve the ICN communication within the network and toward external partners / collaborators. The workshop was organized by the ICN Operations Team and led by EMBRIO GmbH. Britta Lang (Freiburg), Gabriela Senti (Zurich), Thomas Hiemstra (Cambridge) and Yagiz Uresin (Istanbul) acted as ICN representatives during the workshop.

During the workshop a better understanding of who our stakeholders are and what their expectations regarding ICN was achieved. This should help us to address their needs more effectively.

KTA is piloting a new service – Rent a Research Nurse

It is central to have available research nurses when conducting clinical studies. However, in Sweden there is a shortage of research nurses which means that clinics may have to refuse clinical studies due to lack of resources. KTA has therefore started a pilot project where research nurses are rented out to increase the possibilities for clinics to start, conduct and participate in academic and industrial-funded clinical studies.
The overall goal is to offer flexible solutions for both shorter and longer assignments. KTA hopes that more clinics will be able to participate in clinical studies when the hired research nurse takes care of the study-related work. The pilot project will continue during 2019 and then be evaluated. KTA starts on a small scale with two rentable research nurses and a limited number of assignments in the Region of Stockholm.

HCTC GmbH is now the HCTC-KKS

The Hannover Clinical Trial Center (HCTC GmbH, Germany), was founded in 2005. It is a competent and reliable partner for scientific institutions and companies for all aspects for clinical research and development.

On 19th December 2019 HCTC GmbH was incorporated into the Hannover Medical School and is now the HCTC-KKS (Coordinating Center for Clinical Studies) at Hannover Medical School.

Dr. Thomas Hiemstra is the new ICN Vice-Chairperson

Dr. Hiemstra is a Lecturer in Trials at the University of Cambridge and Honorary Consultant Nephrologist at Addenbrooke’s Hospital, Cambridge.
He is chair of the UK National Renal Trials Network and Director of the Patient Led Research Hub. He has an interest in efficient trials design. Dr Hiemstra leads a portfolio that includes Phase I to Phase IV trials, and holds several trials research funding awards from the National Institute for Health Research and the Medical Research Council.

Dr. Hiemstra was appointed as new ICN Vice-Chairperson at the annual ICN Steering Board Meeting, which took place in Istanbul on 14th September 2018.

Phase I Clinical Research Unit in Shanghai has increased its bed number up to 92

Our ICN founding member Shanghai Clinical Research Center (SCRC) and its Phase I Clinical Research Unit (SCRC-PCRU) is a leading organization involved in Phase I Clinical Trials in China.

Initially located at the Xuhui Central Hospital (see pictures), the 56-bed unit was recently provided with a newly renovated extension with a floor area of 1,000 square meters in hospital Branch (located in ChaLing Road), making a total of 2500 square meters, and the bed number has been increased up to 92 beds. It is devoted to conducting bioequivalence trials and new drug (Phase I) studies, ensuring the highest quality medical care an safety standards. Furthermore, the SCRC is planning to set-up an upgraded clinical research platform, while the Phase I Unit will be enlarged to around 500 beds in three-year time.

We warmly congratulate our colleagues at the SCRC for this achievement and wish them all success for the upcoming development phase!

HKU-CTC's data management team trained CMUH-CTC on REDCap EDC System

Our regular ICN member, China Medical University Hospital Clinical Trial Center (CMUH-CTC) visited Clinical Trials Centre, The University of Hong Kong (HKU-CTC) during 12-15 March 2018 for a 4-day practical workshop on REDCap EDC system for data management. HKU-CTC’s data management team introduced the features and functionalities of REDCap EDC system through lectures and interactive practical exercises. HKU-CTC received positive and encouraging feedbacks from the participants.

Congratulations to Henry Yau, Creany Wong and the whole HKU-CTC for the successful ICPOEP 2018!

The 4th International Conference on Phase 1 & Early Phase Clinical Trials (ICPOEP 2018) was successfully organized by The University of Hong Kong Clinical Trials Centre (HKU-CTC) during 1-2 March, 2018. With the keen contribution by 38 world renowned speakers and session chairs, the event attracted the enthusiastic participation of more than 300 delegates from 11 countries/places in North America, Europe and Asia. ICN members in Asia - including the Institute for Advancement of Clinical and Translational Science of Kyoto University Hospital, Japan (iACT), Singapore Clinical Research Institute (SCRI), China Medical University Hospital Clinical Trial Center, Taiwan (CMUH CTC) and HKU-CTC – took the opportunity to gather and update each other of their latest developments!

Meeting “Clinical Research and Data: Beyond Technology, Speed and Innovation”

On 9 November 2017, at the Cemil Bilsel Hall of the Faculty of Science of Istanbul University, International Clinical Trial Center Network (ICN), health authorities, industry representatives, lawyers and patient rights advocates gathered and discussed how to use the available data in Turkey more efficiently during the symposium “Clinical Research and Data: Beyond Technology, Speed and Innovation".

Information and data management have come into spotlight in the field of clinical research. Carrying out clinical trials in a cyber ecosystem is no longer a fictive statement. While well-known challenges remain (regulation on personal data protection, ethical reservations, putative changes in scientific data generation…), the development of big data and artificial intelligence, together with biotechnology, will mark a new era in the use of real life data and data management in clinical trials.

During this meeting, the ICN Members Zurich, Cambridge and Rome have provided insight on what can be done on a central level by sharing their own examples, such as applicable databases, hospital electronic patient records, data migration methods, usage of big data, legal and ethical barriers, country clinical research, health system and patient databases and data management systems utilized at the sites.
This sharing of experiences will empower Turkish sites, governmental and health agencies and industry to initiate and maintain such technological systems in Turkey. Protocol designs need to be smarter and more cost effective. Additionally, the exchange of experiences will allow to take advantages to diagnose and prevent diseases proactively. Apart from data of randomized trials, there is significant amount of Real-World data in Turkey, which needs to be integrated more efficiently.

This baseline meeting identified data sources and integration methods, analyzed the requirements of the country and the patients and discussed and considered the underlying ethical and legal aspects. All attendees have noted that these areas need to be improved. By using big data more effectively and systematically, a shortening in the regulatory timelines and a decrease in research cost could be implemented and are not a dream!

ICN is on LinkedIn

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4TH ICN SYMPOSIUM SEPTEMBER 2018

The next ICN Meeting will take place in Istanbul on 13./14. September 2018. More details about the Symposium will follow soon.

3RD ICN SYMPOSIUM AUGUST 2017

The Singapore Clinical Research Institute (SCRI) held the joint 3rd Annual Symposium SCRI-ICN. This year’s topic was “Advancing Clinical Research Through Expertise Development”. It took place in Singapore on 29th August 2017. ICN members and local clinical stakeholders had the opportunity to discuss on strategies to maximize clinical research, challenges in conducting international clinical trials, clinical trial operational planning and budgeting, and best practice in site operations.

During this Symposium, the SCRI Academy was launched. This Academy will house the learning and development programs for clinical research coordinators in Singapore.
In addition, the challenges for maximizing clinical research in a small footprint, such as Singapore and Switzerland, were addressed by the outgoing ICN Chairperson, Prof. Dr. Gabriela Senti.

Programme Symposium Singapore

Kidney Research UK Fellowship

We are delighted to announce that Dr. Ragada El-Damanawi, a renal medicine trainee from Cambridge, has been awarded a very prestigious and highly competitive fellowship from Kidney Research UK, the leading UK based charity committed to research into the treatment and prevention of kidney disease. Her project titled "Assessing disease modifying therapies in Autosomal Dominant Polycystic Kidney Disease (ADPKD)" will focus on the development of low cost and accessible therapies to slow the progression of polycystic kidney disease, the fourth leading global cause of kidney failure. The fellowship will also provide essential training in the design and set up of global clinical trials under the supervision of Dr. Thomas Hiemstra and the Cambridge Clinical Trials Unit. The ICN supported Dr El-Damanawi's application. Work has already started on a single-centre randomised feasibility trial, and the ICN looks forward to supporting this exciting joint project.

Congratulations for this prestigious award!

2nd ICN SYMPOSIUM SEPTEMBER 2016

The 2nd ICN Symposium Connecting Excellence in Clinical Research – a global perspective was held in Kyoto on 29th September 2016. This year’s topic was “Improving efficiency while maintaining quality”. ICN members shared their experiences on improving quality and efficiency of clinical research through international collaborations. Representatives of the ICN newest regular member, the China Medical University Hospital Clinical Trial Center - Taichung, Taiwan introduced their Institution.
Following presentations of translational Research projects by investigators and representatives of the KAICA Network, a fruitful round table discussion was carried out about how ICN could provide assistance on bench-to-bedside projects.


New members

Two new members joined the ICN in 2017!

- Vanderbilt Institute for Clinical and Translational Research (VICTR), Nashville, US
- Karolinska Trial Alliance (KTA), Stockholm, Sweden


One new member joined the ICN in 2016!

- Clinical Trial Center of Excellence, China Medical University Hospital, Taichung, Taiwan


Three new members joined the ICN in 2015!

- Centre for Clinical Trials Essen (ZKSE), Germany
- Hannover Clinical Trial Center GmbH, Germany
- Infectious Diseases Institute, Kampala, Uganda

1st ICN Symposium 2015

The International Clinical Trial Center Network (ICN) – connecting clinical trial centers from various leading clinical research institutions in Europe, USA, Asia and Japan – was founded on September 10, 2015 within an Inauguration Meeting in Zurich (Switzerland).