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:2/28/2017)... ... February 28, 2017 , ... Roxanna Cross ... p.m. at the 11th Annual RISE Nashville Summit. RISE Nashville is the healthcare ... and engagement strategies. , The discussion will include best practices for accurate identification ...
(Date:2/27/2017)... ... February 27, 2017 , ... Robert E. Burke, MD, PhD, ... But his impoverished upbringing and life experiences could have led him down a much ... and Inspirational Tales of Parenting, Perseverance and Pediatrics,” Dr. Burke shares a personal account ...
(Date:2/27/2017)... ... ... Carothers is not your typical author. She went from working as a movie extra on ... God, when she isn’t swimming as a performing mermaid. , Her book isn’t typical either. ... offers a comedic look at the dysfunctions of God’s family, before Lucifer was sent to ...
(Date:2/27/2017)... POUGHKEEPSIE, N. Y. (PRWEB) , ... February 27, 2017 , ... ... Society ( ILADS ) has disclosed that despite scientific studies, the Center for Disease ... of chronic Lyme disease . Kenneth B. Liegner, M.D. has compiled into ...
(Date:2/27/2017)... ... February 27, 2017 , ... Silicon Valley Hair Institute, a ... an upgrade to the company's Yelp listing. Bay Area residents struggling from thinning ... as Platelet Rich Plasma (PRP) therapy, hair transplantation techniques such as Follicular Unit ...
Breaking Medicine News(10 mins):
(Date:2/27/2017)... 27, 2017  International Biophysics Corporation, a global medical device ... announced a 34% revenue growth in 2016 when compared to ... sales.  This growth was fueled by its AffloVest® sales in ... the expansion of its global sales of surgical product lines. ... "As we enter our 25 th year in delivering ...
(Date:2/27/2017)... ROCKVILLE, Md. , Feb. 27, 2017 /PRNewswire/ ... "RegeneRx"), a clinical-stage drug development company focused on ... its licensee for RGN-137, GtreeBNT Co., Ltd., received ... its Phase 3 clinical trial design for RGN-137 ... dermal wound healing gel that incorporates Thymosin beta ...
(Date:2/27/2017)... February 27, 2017 Leading Countries, Technologies and ... is expected to grow at a CAGR of 8.9% from 2016-2021 ... grow at a CAGR of 9.1% from 2016 to 2027. The ... ... will benefit you Read on to discover how you can ...
Breaking Medicine Technology: