scholarly journals Standardization of pathologic evaluation and reporting of postneoadjuvant specimens in clinical trials of breast cancer: recommendations from an international working group

2015 ◽  
Vol 28 (9) ◽  
pp. 1185-1201 ◽  
Author(s):  
Elena Provenzano ◽  
◽  
Veerle Bossuyt ◽  
Giuseppe Viale ◽  
David Cameron ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Working Group ◽  
International Working Group ◽  
Pathologic Evaluation

scholarly journals National Cancer Institute Breast Cancer Steering Committee Working Group Report on Meaningful and Appropriate End Points for Clinical Trials in Metastatic Breast Cancer

2018 ◽  
Vol 36 (32) ◽  
pp. 3259-3268 ◽  
Author(s):  
Andrew D. Seidman ◽  
Louise Bordeleau ◽  
Louis Fehrenbacher ◽  
William E. Barlow ◽  
Jane Perlmutter ◽  
...  
Keyword(s):  
Breast Cancer ◽  
Clinical Trials ◽  
Metastatic Breast Cancer ◽  
National Cancer Institute ◽  
Working Group ◽  
Metastatic Breast ◽  
Steering Committee ◽  
End Points ◽  
Biologic Subtype ◽  
Line Of Therapy

Purpose To provide evidence-based consensus recommendations on choice of end points for clinical trials in metastatic breast cancer, with a focus on biologic subtype and line of therapy. Methods The National Cancer Institute Breast Cancer Steering Committee convened a working group of breast medical oncologists, patient advocates, biostatisticians, and liaisons from the Food and Drug Administration to conduct a detailed curated systematic review of the literature, including original reports, reviews, and meta-analyses, to determine the current landscape of therapeutic options, recent clinical trial data, and natural history of four biologic subtypes of breast cancer. Ongoing clinical trials for metastatic breast cancer in each subtype also were reviewed from ClinicalTrials.gov for planned primary end points. External input was obtained from the pharmaceutic/biotechnology industry, real-world clinical data specialists, experts in quality of life and patient-reported outcomes, and combined metrics for assessing magnitude of clinical benefit. Results The literature search yielded 146 publications to inform the recommendations from the working group. Conclusion Recommendations for appropriate end points for metastatic breast cancer clinical trials focus on biologic subtype and line of therapy and the magnitude of absolute and relative gains that would represent meaningful clinical benefit.

scholarly journals BIOMARKERS OF SARCOPENIA IN CLINICAL TRIALS RECOMMENDATIONS FROM THE INTERNATIONAL WORKING GROUP ON SARCOPENIA

2012 ◽  
pp. 1-9
Author(s):  
M. CESARI ◽  
R.A. FIELDING ◽  
M. PAHOR ◽  
B. GOODPASTER ◽  
M. HELLERSTEIN ◽  
...  
Keyword(s):  
Skeletal Muscle ◽  
Clinical Trials ◽  
Working Group ◽  
Task Force ◽  
Scientific Progress ◽  
Health Priorities ◽  
International Working Group ◽  
Age Related ◽  
The Subject ◽  
Preliminary Phase

Sarcopenia, the age-related skeletal muscle decline, is associated with relevant clinical and socioeconomic negative outcomes in older persons. The study of this phenomenon and the development of preventive/therapeutic strategies represent public health priorities. The present document reports the results of a recent meeting of the International Working Group on Sarcopenia (a task force consisting of geriatricians and scientists from academia and industry) held on June 7-8, 2011 in Toulouse (France). The meeting was specifically focused at gaining knowledge on the currently available biomarkers (functional, biological, or imaging-related) that could be utilized in clinical trials of sarcopenia and considered the most reliable and promising to evaluate age-related modifications of skeletal muscle. Specific recommendations about the assessment of aging skeletal muscle in older people and the optimal methodological design of studies on sarcopenia were also discussed and finalized. Although the study of skeletal muscle decline is still in a very preliminary phase, the potential great benefits derived from a better understanding and treatment of this condition should encourage research on sarcopenia. However, the reasonable uncertainties (derived from exploring a novel field and the exponential acceleration of scientific progress) require the adoption of a cautious and comprehensive approach to the subject.

scholarly journals Assessment in Ankylosing Spondylitis International Working Group/Spondylitis Association of America recommendations for conducting clinical trials in ankylosing spondylitis

2005 ◽  
Vol 52 (2) ◽  
pp. 386-394 ◽  
Author(s):  
D�sir�e van der Heijde ◽  
Maxime Dougados ◽  
John Davis ◽  
Michael H. Weisman ◽  
Walter Maksymowych ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Ankylosing Spondylitis ◽  
Working Group ◽  
International Working Group

SARCOPENIA: HAVE WE REACHED THE CONSENSUS?

2012 ◽  
pp. 1-4
Author(s):  
L.-K. CHEN
Keyword(s):  
Clinical Trials ◽  
Older People ◽  
Working Group ◽  
Physical Disabilities ◽  
Adverse Outcomes ◽  
Economic Losses ◽  
International Consensus ◽  
International Working Group ◽  
Age Related ◽  
The Impact

Sarcopenia, the age-related loss of skeletal muscle mass, may cause substantial social and economic losses due to its associations with a number of adverse outcomes in the older people, such as falls, hip fractures, physical disabilities, institutionalizations and death (1-5). Although the impact of sarcopenia to the health of older people has been demonstrated, extensive research works are still needed to reach an international consensus with regard to its diagnosis and treatment. The International Working Group of Sarcopenia successfully invited geriatricians and scientists in this domain and formulated recommendations for clinical trials of sarcopenia in Toulouse, France (6). The International Working Group of Sarcopenia reviewed current evidences in definitions, diagnosis, biomarkers and clinical implications of sarcopenia, to provide some critical information for the study design of clinical trials of sarcopenia. Although the International Working Group of Sarcopenia has developed consensus in many dimensions of clinical trials of sarcopenia, some controversies remained unclear still which deserve more works in the future. Some controversies were summarized as below:

scholarly journals Biomarkers of sarcopenia in clinical trials-recommendations from the International Working Group on Sarcopenia

2012 ◽  
Vol 3 (3) ◽  
pp. 181-190 ◽  
Author(s):  
Matteo Cesari ◽  
Roger A. Fielding ◽  
Marco Pahor ◽  
Bret Goodpaster ◽  
Marc Hellerstein ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Working Group ◽  
International Working Group

scholarly journals Standardization of terminology, definitions and outcome criteria in immune thrombocytopenic purpura of adults and children: report from an international working group

Blood ◽  
2009 ◽  
Vol 113 (11) ◽  
pp. 2386-2393 ◽  
Author(s):  
Francesco Rodeghiero ◽  
Roberto Stasi ◽  
Terry Gernsheimer ◽  
Marc Michel ◽  
Drew Provan ◽  
...  
Keyword(s):  
Clinical Trials ◽  
Immune Thrombocytopenic Purpura ◽  
Working Group ◽  
Treatment Modalities ◽  
Scientific Quality ◽  
Clinical Expertise ◽  
Thrombocytopenic Purpura ◽  
International Working Group ◽  
Meta Analyses ◽  
Outcome Criteria

Diagnosis and management of immune thrombocytopenic purpura (ITP) remain largely dependent on clinical expertise and observations more than on evidence derived from clinical trials of high scientific quality. One major obstacle to the implementation of such studies and in producing reliable meta-analyses of existing data is a lack of consensus on standardized critical definitions, outcome criteria, and terminology. Moreover, the demand for comparative clinical trials has dramatically increased since the introduction of new classes of therapeutic agents, such as thrombopoietin receptor agonists, and innovative treatment modalities, such as anti-CD 20 antibodies. To overcome the present heterogeneity, an International Working Group of recognized expert clinicians convened a 2-day structured meeting (the Vicenza Consensus Conference) to define standard terminology and definitions for primary ITP and its different phases and criteria for the grading of severity, and clinically meaningful outcomes and response. These consensus criteria and definitions could be used by investigational clinical trials or cohort studies. Adoption of these recommendations would serve to improve communication among investigators, to enhance comparability among clinical trials, to facilitate meta-analyses and development of therapeutic guidelines, and to provide a standardized framework for regulatory agencies.

MDS-Patienten mit stabiler Erkrankung profitieren von kontinuierlicher Azacitidin- Therapie

2010 ◽  
Vol 01 (04) ◽  
pp. 161-162
Author(s):  
Günter Springer
Keyword(s):  
Working Group ◽  
International Working Group ◽  
American Society

Patienten mit Myelodysplastischem Syndrom (MDS) und Krankheitsstabilisierung (SD) als erstes Ansprechen haben unter kontinuierlicher Behandlung mit Azacitidin (Vida-za®) gute Aussichten, noch ein Ansprechen gemäß Kriterien der International Working Group (IWG) und dadurch einen Überlebensvorteil zu erreichen. Zu diesem Ergebnis kam eine auf dem Kongress der American Society of Oncology (ASCO) vorgestellte Analyse der Zulassungsstudie AZA-001.

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