ArticlePDF Available

Responding to the challenges of international collaborations between the east and the west - report of the first JCOG-EORTC symposium and a perspective from young JCOG and EORTC investigators



International/intercontinental collaboration is necessary to set up new innovative clinical trials for cancer treatment. However, the infrastructure, especially Asia-Europe academic partnerships, to enable such collaboration has not been fully structured and differences and similarities between the research groups have not been well studied. In 2015, collaboration started between the biggest cancer research organizations in Asia and EU, Japan Clinical Oncology Group (JCOG) and European Organisation for Research and Treatment of Cancer (EORTC). Following the first pilot collaboration study, the first scientific symposium took place in December 2017 in Tokyo. Before the symposium, a working visit for EORTC investigators from the Early Career Investigator initiative (ECI), willing to develop projects within the JCOG-EORTC partnership, was held. In addition to the digest of the working visit and symposium, we aimed to describe the differences and similarities between the two groups and to identify key factors for collaboration from the perspective of the young investigators of the networks. These findings are described in this article.
JCO Japanese Journal o
Clinical Oncology
Japanese Journal of Clinical Oncology, 2019, 49(1) 9699
doi: 10.1093/jjco/hyy155
Advance Access Publication Date: 5 November 2018
Responding to the challenges of international
collaborations between the east and the west
report of the first JCOGEORTC symposium and
a perspective from young JCOG and EORTC
Kozo Kataoka
*, Orit Kaider-Person
, Bernd Kasper
Patrick Starlinger
, Carmela Caballero
, Jessica Menis
Lizza E. Hendriks
, Mitsumi Terada
, Laurence Collette
Kenichi Nakamura
, Denis Lacombe
, and Haruhiko Fukuda
Division of Lower GI, Department of surgery, Hyogo College of Medicine,
JCOG Data Center/operations office,
National Cancer Center,
International Trials Management Section, Clinical Research Support Office, National
Cancer Center Hospital, Japan,
Radiation Oncology Unit, Oncology Institute Rambam Medical Center, Israel,
Sarcoma Unit, Interdisciplinary Tumor Center, Mannheim University Medical Center, Germany,
Department of
Surgery, Medical University of Vienna, Austria,
EORTC Headquarters, Belgium,
Drug Development Department,
Gustave Roussy Cancer Campus Grand Paris, France,
Department of Surgery, Oncology and Gastroenterology,
University of Padua, Padua, Italy, and
Department of pulmonary diseases, GROW School for Oncology and
Developmental Biology, Maastricht University Medical Center, The Netherlands
*For reprints and all correspondence: Kozo Kataoka, 1-1 Mukogawa-cho Nishinomiya, Hyogo, Japan. E-mail:
International/intercontinental collaboration is necessary to set up new innovative clinical trials for
cancer treatment. However, the infrastructure, especially AsiaEurope academic partnerships, to
enable such collaboration has not been fully structured and differences and similarities between
the research groups have not been well studied. In 2015, collaboration started between the biggest
cancer research organizations in Asia and EU, Japan Clinical Oncology Group (JCOG) and
European Organisation for Research and Treatment of Cancer (EORTC). Following the first pilot
collaboration study, the first scientific symposium took place in December 2017 in Tokyo. Before
the symposium, a working visit for EORTC investigators from the Early Career Investigator initia-
tive (ECI), willing to develop projects within the JCOGEORTC partnership, was held. In addition to
the digest of the working visit and symposium, we aimed to describe the differences and similar-
ities between the two groups and to identify key factors for collaboration from the perspective of
the young investigators of the networks. These findings are described in this article.
Key words: JCOGEORTC, ECIs, EORTC fellowship
Nowadays international collaborations are strategically important
to take up the challenges of modern clinical research such as, but
not limited to, multidisciplinary quality assurance programs and
subgroup fragmentation of diseases. Intergroup studies, notably
those done between the Europe and North America have changed
© The Author(s) 2018. Published by Oxford University Press. All rights reserved. For permissions, please e-mail: 96
Downloaded from by guest on 17 January 2022
practice and/or brought additional knowledge (13). Such collabor-
ation between Europe and Asia is essential to allow knowledge
development and cross expertise.
Based on this background, since 2015, the Japan Clinical
Oncology Group (JCOG) and the European Organization for
Research and Treatment of Cancer (EORTC) have been working
together to promote partnership in research and to identify strategies
for successful collaborations between the East and the West (4,5).
The JCOG is the largest multicenter clinical study group for cancer
in Japan which is mainly funded by national research grants (68).
The EORTC is the largest international clinical research organization
in the Europe, conducting multidisciplinary clinical trials in all
tumor types. The first pilot collaborative study, the EORTC1527/
JCOG1609INT/ESSO02 [Diffusion-weighted Magnetic Resonance
Imaging Assessment for Liver Metastasis to improve surgical plan-
ning (DREAM) (NCT02781935)], has already recruiting patients
with colorectal liver metastases since 2016 (9,10).
As part of this effort, the first JCOGEORTC Clinical Research
Symposium was held in Tokyo in December 2017. The purpose of
this symposium was to deepen the mutual understanding about the
current perspectives of both cooperative groups and strengthen this
initiative to promote further collaborative projects. Common scien-
tific strategies and unmet needs that could be translated into poten-
tial clinical trials were discussed at the meeting. This symposium
was linked with the Early Career Investigator initiative (ECI), which
provided an opportunity of travel grants for young EORTC investi-
gators willing to develop projects within the JCOGEORTC part-
nership. This was a unique opportunity to motivate the young
investigators to come up with new collaboration projects.
In this article, as well as the digest of the symposium, and the
site visit of ECIs and EORTC visiting Japanese medical fellows, the
differences and similarities between the two groups are assessed,
including key factors for successful collaboration.
Digest of JCOGEORTC symposium
In the two-days meeting, several topics were discussed from both the
JCOG and EORTC side, respectively. On Day 1, the overview and
experience of international clinical trials in both groups were dis-
cussed. It was identified that both academic cooperative groups have
similar structures, moreover the flexible EORTC structure imple-
menting international clinical trials was presented. Details regarding
structures in both groups have been described elsewhere (5). At the
end of the session, the results of surveys sent to key JCOG and
EORTC investigators were presented and indicated that, despite the
existing challenges, the majority of investigators in both territories
are supportive of international collaboration. The result of surveys
will be published in another report. Next, translational research
infrastructures were also discussed to find ways for future collabora-
tions. In both JCOG and EORTC, unique biobanking infrastruc-
tures, JCOG biobank system and SPECTA platform as well as
internal Advisory Committee for translational research, have already
been incorporated. Although there are still some challenges for col-
laboration to overcome, such as shipping of materials and regula-
tory matters, it has been agreed that it is already time to start
working on collaborative translational research using the materials
each group already has.
On Day 2, the similarities and differences were discussed from
the statistical point of view. Two educational topics were presented
from each group; Adaptive design from EORTC and statistical
measures for time-to event from JCOG. Then standard statistical
methodology was compared and discussed. Discussion topics were;
one-sided test vs. two-sided test in superiority setting, timing of event
for progression free survival, policy for interim analysis and popula-
tion for analysis (Intent to Treat vs. per-protocol). It has been con-
cluded that differences of statistical methodology in each group were
minor and they were basically similar. Afterwards strategies of three
disease-oriented groups in JCOG and EORTC (gastrointestinal, lung
and brain) and examples of ongoing clinical trials were presented.
Lastly, in the panel discussion, the key factors to success for this col-
laboration were discussed to enable future collaboration. First, it has
been agreed that mutual communication such as attendance of dis-
ease group meetings in both groups is the first step for collaboration
to share common clinical questions and to establish a worldwide net-
work. Second, it has been agreed that there is an urgent need to
develop the infrastructure which can facilitate international collabor-
ation. Financial resources to cover the activities such as networking,
management of trials, and centralization and quality assurance of
human biological material and other type of data such as imaging
scans, should be secured. Therefore, it has been agreed that, to
achieve these factors, both groups need to assess the feasibility of
research questions early on, in terms of financial and regulatory
aspects and aim to achieve common solutions. Furthermore, every-
body agreed that a good common clinical research question should
come first.
The experiences of EORTC ECIs and Japanese
EORTC fellows
Research fellowships and site visits by young investigators might be
one of the efficient ways to foster reciprocal understanding of each
others culture and research environment. As part of JCOG
EORTC symposium, several ECIs were enabled to visit a Japanese
cancer center and to attend the symposium. ECIs were requested to
submit the application forms including their research collaboration
ideas and winners were selected based on the score of the applica-
tion forms. The score was given carefully and impartially based on
(1) purpose to join this program, (2) passion for collaboration, (3)
academic background, (4) quality of idea of collaboration project,
(5) experience of collaboration experience and (6) quality of applica-
tion form, by the JCOGEORTC steering committee members. Six
ECIs were selected and visited Japanese hospitals for 34 days.
During their visits, they discussed similarities and differences
between their hospital and the Japanese visit hospital. A medical
oncologist and a pulmonologist from the EORTC lung group who
visited the thoracic oncology division in National Cancer center
Hospital, Tokyo, mentioned the higher incidence of early stage can-
cer in Japan compared to Europe. They also mentioned genomic dif-
ferences as Epidermal Growth Factor Receptor (EGFR) mutated
lung cancer is more common in Japan. Furthermore, differences in
drug metabolism in Japanese and Caucasians may lead to different
standard drug doses and other adverse events. Regarding radiother-
apy, a young radiation oncologist from the EORTC radiation group
and European Society for Radiotherapy and Oncology (ESTRO)
noticed that the patient population receiving radiotherapy is differ-
ent (30% in Japan and 60% in Europe), probably due to a Japanese
focus on surgery and a higher percentage of early disease in Japan
due to screening. A young surgeon from EORTC GI group and
European Society and Surgical Oncology (ESSO) who visited hepa-
tobiliary and Pancreas division pointed out the difference in the
Jpn J Clin Oncol, 2019, Vol. 49, No. 1 97
Downloaded from by guest on 17 January 2022
historical role of surgeons. He mentioned that while in Europe, the
medical oncologist has been working closely together with the sur-
geon, the Japanese surgeons seem to integrate these two disciplines,
as clinical oncology remains a fairly young disciplinein Japan.
These aspects should be fully recognized and considered in a collab-
oration project.
On the JCOG side, since 2015, three Japanese fellows already
experienced the actual clinical trial situation in Europe through an
EORTC medical fellowship. Japanese young investigators men-
tioned that not only scientific aspects, but also operational aspects
are needed to understand in collaboration. They said that since
Japan is a homogeneouscountry in many senses, Japanese have to
understand the complicated and diverse Europe regulations and dif-
ficulty of financial support in pan-Europe clinical trials (5,11,12). It
took some time to launch the first pilot trials due to preparation
time for translation and contracts. Despite the several differences
mentioned, all the ECIs and Japanese EORTC fellows concluded
that it is first step to know the differences and similarities between
the Europe and Asia for successful EORTCJCOG collaboration
which can affect the practice of all over the world.
Summary and future perspective
The main objective of this exercise was to address the needs for clin-
ical trial collaboration and where Asia can enter in such initiatives.
In this symposium, the similarities and differences between the two
groups were fully discussed; the two groups are similar in the basic
structure of headquarters, translational research infrastructures and
standard statistical methodology, but they differ in the standard
treatment in some disease groups, the infrastructure facilitating
international clinical trials, details of statistical methodology, regula-
tory process and financial support. These have been addressed in a
previous collaboration paper (5). Additionally, during the sympo-
sium, it has been agreed that mutual communication should be
maintained across disease groups to facilitate development of trans-
versal projects with common scientific questions. This will poten-
tially open more opportunities for collaboration and financing. Both
groups need to be vigilant in obtaining alternative sources of fund-
ing academic pursuits. Lastly, the working visit by ECIs made us
realize that such personal and dynamic interaction across cultures is
one of the most effective ways to bridge the gap between the two
groups. For young investigators it is easier to come up with clinical
questions relevant for both groups when they have the chance to be
engaged with experts and mentors and when they are exposed to
different working environments early in their career. Furthermore,
by giving young investigators opportunities to be involved in the
management of clinical trials, they can better understand clinical
unmet needs or operational issues across countries. Such knowledge
and understanding are critical for a sustainable Asian-European col-
laboration. An example of the active involvement of an ECI in a
clinical trial is in the EORTC lung cancer group which appoints a
young investigator for each new trial to manage the clinical trial
together with a senior investigator.
Several initiatives are ongoing to further expand the portfolio
between JCOG and EORTC. First, the opportunity for further com-
munication has already been prepared. A second JCOGEORTC
symposium related to quality of life has taken place last September
2018. In disease group level, EORTCJCOG exchange program has
been already started. Some Japanese investigators have been invited
to the disease group meeting to share their thoughts. Additionally,
several Japanese applicants are now under negotiation with EORTC
headquarters for the future EORTC medical fellow. Through these
exchange initiatives, the chance to come up with attractive common
clinical question will certainly increase. After increasing the oppor-
tunity for mutual communication, the next step is to secure the
grants. To make this initiative visible, one of the solutions may be to
invite fund bodies such as pharma companies to the future sympo-
sium for encouraging them to find the value of our collaboration
and getting support from them. The advantage of the combined net-
works of EORTC and JCOG must be used as a leverage to seek for
funding and support internationally.
With the working visit and the first joint scientific symposium, sev-
eral challenges have been identified such as differences in standard
treatments and regulatory matters including financial support.
However, we have reasons to be optimistic because through a series
of these collaborative projects, we found that we have a common
vision and mission for practice changing, high quality clinical trials.
The field of cancer research is evolving very fast so that academic
networks like JCOG and EORTC need to work together to define
and direct the future of cancer research. The exchange program,
such as ECI program and EORTC fellowship is one of the routes to
bridge the gap between the Asia and Europe and to foster the inter-
national academic trial platform which helps conducting global
intercontinental clinical research smoothly.
All authors of this articles are below:
Kozo Kataoka, Orit Kaider-Person, Bernd Kasper, Patrick
Starlinger, Carmela Caballero, Jessica Menis, Lizza E. Hendriks,
Mitsumi Terada, Laurence Collette, Junko Eba (JCOG Data Center/
operations office, National Cancer Center, Japan), Kenichi
Nakamura, Denis Lacombe and Haruhiko Fukuda.
The authors thank EORTC investigators and JCOG investigators who
answered the questions, especially Yuko Kitagawa, Yasuhiro Matsumura,
Ken Kato, Sabine Tejpar, Serge Evrard, Vassilis Golfinopoulos, Yuichiro Ohe,
Takeshi Sano, Junki Mizusawa, Yukihide Kanemitsu, Masanori Terashima,
Benjamin Besse, Ryo Nishikawa, Taro Shibata, Michael Weller, Toshirou
Nishida and Hitoshi Nakagama for their presentation and Makiko Watanabe
for her involvement as steering committee.
This work is supported by Practical Research for Innovative Cancer
Control from Japan Agency for Medical Research and Development,
AMED (18ck0106211h0003) and Global Clinical Trial Development
Project of Japan Agency for Medical Research and Development,
AMED (16lk1203001j0001, 17lk1503003j001, 18lk1503003j002).
The National Cancer Center Hospital, which also functions as the
headquarters of the Japan Clinical Oncology Group, is appointed as
Global Clinical Trial Core Centers of AMED.
Conflict of interest statement
None declared.
98 JCOG and EORTC exchange initiative
Downloaded from by guest on 17 January 2022
1. Lacombe D, Negrouk A, Bean J. International investigator-driven clinical
trials: challenges and opportunities for USEurope cooperation through
the US cooperative group networks. Clin Invest 2011;1:493500.
2. Trimble EL, Abrams JS, Meyer RM, et al. Improving cancer outcomes
through international collaboration in academic cancer treatment trials.
J Clin Oncol 2009;27:510914.
3. Zurlo A, Therasse P. Addressing the challenge of intergroup studies in
oncology: the EORTC experience. Eur J Cancer 2002;38:16972.
4. Kataoka K, Kinoshita T, Moehler M, et al. Current management of liver
metastases from gastric cancer: what is common practice? New challenge
of EORTC and JCOG. Gastric Cancer 2017;20:90412.
5. Kataoka K, Nakamura K, Caballero C, et al. Collaboration between
EORTC and JCOG-how to accelerate global clinical research partnership.
Jpn J Clin Oncol 2017;47:1649.
6. Fukuda H. Development of cancer cooperative groups in Japan. Jpn J
Clin Oncol 2010;40:88190.
7. J. (2 June 2018, date last accessed).
8. Saijo N. Preface for JCOG review series. Jpn J Clin Oncol 2011;41:1155.
9. Evrard S, Audisio R, Poston G, et al. From a comic opera to surcare an
open letter to whom clinical research in surgery is a concern: announcing
the launch of SURCARE. Ann Surg 2016;264:9112.
10. Kataoka K, Caballero CA, Collette L, et al. EORTC1527/JCOG1609INT:
diffusion-weighted MRI (DW-MRI) assessment of liver metastasis to improve
surgical planning (DREAM). J Clin Oncol 2017;35:TPS3633TPS3633.
11. Burock S, Meunier F, Lacombe D. How can innovative forms of clinical
research contribute to deliver affordable cancer care in an evolving health
care environment? Eur J Cancer 2013;49:277783.
12. Lacombe D, Tejpar S, Salgado R, et al. European perspective for effective
cancer drug development. Nat Rev Clin Oncol 2014;11:4928.
Jpn J Clin Oncol, 2019, Vol. 49, No. 1 99
Downloaded from by guest on 17 January 2022
... Recently, the JCOG and the EORTC strengthened their ties to facilitate intercontinental collaborations through conducting collaborative trials and projects (e.g. EORTC-1527-GITCG-IG: DREAM-Diffusion-Weighted Magnetic Resonance Imaging Assessment of Liver Metastasis to Improve Surgical Planning, and the first JCOG-EORTC scientific symposium took place in December 2017 in Tokyo) (4,5). For further cooperation, the gap in the stance about QOL research between EORTC and JCOG should be bridged. ...
Full-text available
This report summarizes the presentations and discussion in the first Japan Clinical Oncology Group-European Organisation for Research and Treatment of Cancer Quality of Life/Patient-Reported Outcome workshop funded by the National Cancer Center Hospital that was held on Saturday, 1 September 2018 in Tokyo, Japan. The infrastructure and understanding regarding the Quality of Life/Patient-Reported Outcome assessment of cancer patients in Japan is still immature, in spite of the increased demand for oncological Patient-Reported Outcome research felt not only by researchers but also by patients or other stakeholders of cancer drug development. The workshop aimed to share each perspective, common issues to be considered and future perspectives regarding the strong alliance between the European Organisation for Research and Treatment of Cancer Quality of Life Group and the Japan Clinical Oncology Group for Quality of Life/Patient-Reported Outcome research as well as explore the possibility of conducting collaborative research. European Organisation for Research and Treatment of Cancer is a leading international cancer clinical trials organization, and its Quality of Life Group is a global leader in the implementation of Quality of Life research in cancer patients. The three invited speakers from the European Organisation for Research and Treatment of Cancer Quality of Life Group presented their perspective, latest methodology and ongoing projects. The three speakers from the Japan Clinical Oncology Group presented their current status, experience and some issues regarding data management or interpretation of the Patient-Reported Outcome data. The two patient advocates also shared their expectations in terms of advances in cancer research based on the Patient-Reported Outcome assessment. As the next steps after this workshop, the Japan Clinical Oncology Group and European Organisation for Research and Treatment of Cancer have decided to cooperate more closely to facilitate Patient-Reported Outcome research in both the groups, and the Japan Clinical Oncology Group has approved the establishment of a new committee for Quality of Life/Patient-Reported Outcome research in Japan.
... EORTC and JCOG believe in international, multidisciplinary collaboration [23,24] including surgery, medical oncology, pathology, gastroenterology, endoscopy, radiology, nuclear medicine, radiotherapy and biostatistics to further improve treatment outcomes for patients with GEJ and GC. ...
Full-text available
The aim of this manuscript is to discuss the viewpoint of the European Organisation for Research and Treatment of Cancer (EORTC) Gastric Cancer Taskforce and Japan Clinical Oncology Group (JCOG) Gastric Cancer Study Group on the current challenges in the multidisciplinary management of stage II-III gastric and gastro-oesophageal junction (GEJ) cancer. We seek to outline how these challenges are addressed in current trials of both groups. Key elements of future trials of EORTC and JCOG in this indication are described, and a joint vision on how multidisciplinary research of gastric and GEJ cancer patients should be organised is outlined.
TPS3633 Background: For patients with initially unresectable colorectal liver metastases (CRLM) with good clinical response to chemotherapy, the presence of disappearing liver metastases (DLMs) diagnosed by CT is a major independent prognostic factor. DW-MRI as well as contrast enhanced (CE)-MRI is recommended to detect and characterize CRLM. However, the correlation between radiological and pathological complete response has not been fully investigated using these latest imaging and pathology techniques. Our main aim is to demonstrate the added value of DW-MRI, CE-MRI to that of CT alone to provide precise assessment of the viability of DLMs. In addition, we aim to optimize the therapeutic management of CRLM patients. No prospective study has been conducted to determine the predictive value of DW-MRI combined with CE-MRI in confirming sites of DLMs and assessing their true status. Methods: This is the first collaborative study between EORTC, ESSO and JCOG with an integrated quality assurance program for imaging, surgery and pathology. Patients with unresectable CRLM will receive standard systemic chemotherapy and liver resection if resectable. Both CT and MRI (DW-MRI, CE-MRI and T1/T2) will be used to identify confirmed DLMs (cDLMs). cDLMs will be either resected or, if resection is not possible, followed-up without resection until 2 years after surgery to evaluate the true status of the cDLMs. The primary endpoint is negative predictive value (NPV) of DW-MRI, CE-MRI, T1/T2 and CT in confirming the status of cDLMs using as reference either the histopathological complete response or the absence of a local recurrence at the site of cDLMs during the follow up period of 2 years. The study aims at excluding a NPV≤0.85 and is powered under the alternative that the NPV≥0.95. The planned sample size is 92 evaluable (resected or left behind) cDLMs, with a 1-sided alpha of 5% and a power of 90% adjusting for within-patient correlation between cDLMs of 0.2 and an average number of 2 cDLMs per patient. Approximately 400 patients will be registered from European, Japanese and US sites over 3 years. As of February 2017, 2 patients have been enrolled. Clinical trial information: NCT02781935.
The role of multidisciplinary treatment including surgery for liver metastases from gastric cancer (LMGC) is controversial. Studies to answer this clinical question are increasing in number, but all published data thus far are based on retrospective analyses with limited sample sizes. Thus, the European Organisation for Research and Treatment of Cancer (EORTC) Gastrointestinal Tract Cancer Group (GITCG) and the Japan Clinical Oncology Group (JCOG) Stomach Cancer Study Group (SCSG) initiated a collaboration to develop an optimal treatment strategy for LMGC. Before planning a prospective study, a questionnaire was sent out to the network members of both groups in June 2016 to clarify current common practice in each region. Sixty-seven sites from 17 countries in the EORTC network and 55 sites from Japan responded. According to the survey, for patients with resectable LMGC without extrahepatic metastases, preoperative chemotherapy followed by resection of both primary (if still in place) and liver lesions was the preferred option for both the synchronous and the metachronous setting. For patients with unresectable LMGC, most of the sites recommended chemotherapy only. In this article, the detailed results of this survey are reported, shedding light on current community practice, and a joint EORTC–JCOG strategy of investigation is delineated.
The demand for international collaboration in cancer clinical trials has grown stronger to maximize efficiency, avoid duplication of effort and to achieve effective implementation of research results into medical practice. Infrastructures that could facilitate intercontinental collaboration not only between Europe and United States but also between Europe and Asia are urgently needed. The European Organisation for Research and Treatment of Cancer, one of the major cancer clinical research infrastructure in Europe, initiated collaboration with the Japan Clinical Oncology Group, the largest cancer research cooperative group in Japan. Their first pilot trial on unresectable colorectal liver metastasis will commence on fourth quarter of 2016. With similar goals and strategies as well as with similar structures, the two research organizations have a great potential for efficient collaboration that could deliver faster and global therapeutic improvement to cancer patients. However, international collaboration requires careful and structured approach to harmonize activities to ensure success. This article focuses on specific intercontinental differences and the necessary requirements to ensure a successful partnership between European Organisation for Research and Treatment of Cancer and Japan Clinical Oncology Group. This could serve as a model to build more global international academic trials between the East and the West.
Health systems and the clinical research landscape evolve continuously owing to increased risk aversion, scrutiny by funding bodies, and costs of clinical trials. In this context, however, current drug development procedures are far from optimal, as exemplified by the late-stage failure of several drugs. The identification of new drugs urgently requires approaches based on a solid understanding of cancer biology, and that will support the design of robust confirmatory trials. The complexity and the costs of drug development are now beyond the knowledge and operational capacity of single organisations, therefore, a drastic deviation from the traditional path of drug discovery and new forms of multidisciplinary partnerships are needed to succeed in this sector. The European Organisation for Research and Treatment of Cancer (EORTC) proposes the use of collaborative molecular screening platforms (CMSPs) as a new approach to tackle this issue. These CMSPs have the advantage of optimizing the expertise of several partners and combining efforts alongside with cost-sharing models for efficient patient selection. This article describes some of the challenges to advancing drug development and improving medical treatments and how these hurdles can be overcome.
Intergroup studies are conducted by more than one clinical research group. There are several difficulties that hamper in practice the possibility of conducting such trials, as all interested parties will have to address unusual and complex issues. These are mainly related to differences in size, interests, motivations and means among different research organisations. The EORTC recognises the importance to promote intergroup collaboration providing to all interested groups the necessary expertise and organisational support to conduct intergroup studies. The role of the EORTC evolved from the spontaneous organisations of intergroup trials to the definition of a basic set of principles and criteria that groups have to fulfil to participate in intergroup trials. Recently, a specific EORTC Intergroup Office started its activity devoted to solve the issues related to the intergroup co-operation. This office will have an increasing role to promote and help in conducting intergroup studies.
As health care costs are constantly rising and governments are reforming their healthcare systems there is an urgent need to reshape the European clinical research landscape. To bridge the translational gap extensive research to understand the mechanism of the agents and of the disease has to be performed and the real benefit of drugs needs to be assessed independently. Furthermore, meaningful data for reimbursement strategies will be a major goal of future clinical trials as well. Therefore, a new integrated model of clinical cancer research is needed to optimise the R&D process. Strategies to ensure that we can gather robust and relevant data about the effectiveness of various healthcare interventions have to be developed to provide optimal patient care within the limits of a healthcare budget.
Investigator-initiated clinical trials are essential for improving the standard of care for cancer patients, because pharmaceutical companies do not conduct trials that evaluate combination chemotherapy using drugs from different companies, surgery, radiotherapy or multimodal treatments. Government-sponsored cooperative groups have played a vital role in developing cancer therapeutics since the 1950s in the USA; however, the establishment of these groups in Japan did not take place until 30 years later. Methodological standards for multicenter cancer clinical trials were established in the 1980s by the National Cancer Institute and cooperative groups. The Japan Clinical Oncology Group, one of the largest cooperative groups in the country, was instituted in 1990. Its data center and operations office, formed during the 1990s, applied the standard methods of US cooperative groups. At present, the Japan Clinical Oncology Group consists of 14 subgroups, a Data Center, an Operations Office, nine standing committees and an Executive Committee represented by the Japan Clinical Oncology Group Chair. Quality control and quality assurance at the Japan Clinical Oncology Group, including regular central monitoring, statistical methods, interim analyses, adverse event reporting and site visit audit, have complied with international standards. Other cooperative groups have also been established in Japan since the 1980s; however, nobody figures out all of them. A project involving the restructuring of US cooperative groups has been ongoing since 2005. Learning from the success of this project will permit further progress of the cancer clinical trials enterprise in Japan.