Navigation Links
NCI, NCRI and EORTC outline risk-assessment approach for biomarker-driven cancer clinical trials
Date:4/29/2014

In an article published in The Lancet Oncology, an NCI (US National Cancer Institute), NCRI (UK National Cancer Research Institute), and EORTC (European Organisation for Research and Treatment of Cancer) working group outline a practical risk-management approach for effective integration of biomarkers into cancer clinical trials. Their work provides the international community with a set of common principles by which biomarkers can be integrated into clinical trials, exchange of data can be facilitated, quality promoted, and research accelerated while simultaneously respecting local approaches and legislation.

Their risk-assessment approach for designing and conducting cancer clinical trials include risks to patient safety, operational risks, and biomarker development risks, and for each risk they evaluate possible consequences, provide solutions along with examples of these as well as references to helpful resources. Concerning protocol design, the working group recommends items that a protocol should include as well as items that should be assessed during protocol development. For the conduct of the trial, they make recommendations for the close monitoring of variability in test results, and they also make recommendations for particular aspects following completion of the trial.

Dr. Jacqueline Hall, who coordinated this NCI, NCRI, and EORTC working group says, "We readily acknowledge that in today's clinical trial landscape, many stakeholders play a role in clinical trials. These include regulators, public authorities, and patients, amongst others. By opening this discussion to others, we hope to find solutions to the varied challenges facing molecularly driven clinical research."


'/>"/>

Contact: John Bean
john.bean@eortc.be
European Organisation for Research and Treatment of Cancer
Source:Eurekalert

Page: 1

Related medicine news :

1. Media alert: 24th EORTC - NCI - AACR Symposium Molecular Targets and Cancer Therapeutics
2. EORTC led intergroup trial investigates Imatinib failure-free survival in patients with GIST
3. EORTC study identifies patients with anaplastic oligodendroglioma that benefit from adjuvant PCV
4. Markers in Cancer, a joint meeting by ASCO, EORTC & NCI, 7-9 Nov 2013 (diagnostic tutorial on 5-7)
5. EORTC study shows radiotherapy and surgery provide regional control for breast cancer patients
6. EORTC BOS 2 trial opens for patients with resectable liver metastases from colorectal cancer
7. EORTC intergroup trial opens for patients with resected head of pancreas adenocarcinoma
8. EORTC study opens for elderly patients with HER-2 positive metastatic breast cancer
9. Moderate dose radiotherapy effective in EORTC trial for patients with desmoid-type fibromatosis
10. EORTC at 2013 ECCO-ESMO-ESTRO meeting in Amsterdam
11. Vaccination with GM2-KLH-QS21 does not improve outcome of melanomas patients in EORTC study
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:10/13/2017)... ... October 13, 2017 , ... Dickinson ... offers insurance and financial preparation services, is providing an update on a charitable ... , Rock City Rescue is a locally recognized nonprofit that provides shelter and ...
(Date:10/13/2017)... Nevada (PRWEB) , ... October 13, 2017 , ... ... Hemp CBD Oil utilizing Purzorb™ technology. Applying the Purzorb™process to full spectrum CBD oil ... required and providing a CBD form that can be easily incorporated into liquid products, ...
(Date:10/13/2017)... , ... October 13, 2017 , ... The Visiting Nurse ... Market. Featuring a collection of specialty vendors and unique items from across the nation, ... quality-focused health and wellness services offered by the VNA. The boutique will be ...
(Date:10/13/2017)... ... October 13, 2017 , ... Coveros, a leader in agile ... a contract by the Center for Medicare and Medicaid Services (CMS). The Enterprise ... use of Agile methodologies in a consistent and high value manner across CMS ...
(Date:10/12/2017)... ... October 12, 2017 , ... Planet Fitness, one of the largest and fastest ... to open a flagship location in Covington, LA at 401 N. U.S. Highway 190, ... next to Office Depot in the Holiday Square shopping center. Its location allows it ...
Breaking Medicine News(10 mins):
(Date:10/10/2017)... , Oct. 10, 2017   West Pharmaceutical Services, ... solutions for injectable drug administration, today shared the results ... Adapter for improving the intradermal administration of polio vaccines. ... Vaccination Summit in May 2017 by Dr. Ondrej ... Department, World Health Organization (WHO), and recently published in ...
(Date:10/4/2017)... , Oct. 4, 2017 ... single-use, self-contained, illuminating medical devices, today announced regulatory ... Health Surveillance Agency (or Agência Nacional de Vigilância ... first single-use, cordless surgical retractor with integrated LED ... optimal access, illumination and exposure of a tissue ...
(Date:10/2/2017)... The Rebound mobile app is poised to become a vital ... prescription drug addiction. The app empowers users to develop an ... their dosage in a safe, controlled manner while maximizing well-being. ... 100,000 people to sign up will enjoy 3 months of ... ...
Breaking Medicine Technology: