Thursday, February 18, 2010
Correspondence/Reply: Central Institutional Review Board–Facilitated Review Metrics Omit Critical Components
1) CORRESPONDENCE
Central Institutional Review Board–Facilitated Review Metrics Omit Critical Components
Michael S. Katz, Mary L. Smith
Patient Representative Committee, Eastern Cooperative Oncology Group, Philadelphia, PA
To the Editor:
"As cancer survivors and patient advocates, we must take issue with calculations of the impact of the central institutional review board (CIRB) on local institutional review board (IRB) protocol review times and societal costs by Wagner et al.1 The authors' definitions of these metrics omit critical components......Thus, the net impact on IRB review times, which determine how quickly a protocol can move from National Cancer Institute approval to putting patients on-study are actually slower by 66 to 76 days than a stand-alone local review. The suggestion, therefore, that there are "benefits of a more predictable and faster approval process" is not accurate.""
2) CORRESPONDENCE - Reply to M.S. Katz et al
"Recent internal data from National Cancer Institute show that these changes have decreased the length of CIRB review, defined as application receipt to approval, from a median of 95.5 days in 2008 to 45 days for the six trials using the new processes."Author's Reply to Correspondence: Endocrine Effects of Aromatase Inhibitors Journal of Clinical Oncology
" It is somehow astonishing that after approximately 15 years from the first clinical article on anastrozole, exemestane, and letrozole, we still have insufficient or weak knowledge of some of the consequences of their long-term use."
Patient Opinion - NHS (UK) website
Your story can change the NHS * Tell people what happened * See what others are saying * Find out how patients are changing the NHS
Quest, Vermillion 'On Track' to Launch OVA1 in March | GenomeWeb
"OVA1 generates a numerical score based on five immunoassays that is intended to help physicians determine the likelihood of malignancy in women with pelvic mass for whom surgery is planned."
HDAC Inhibitors in Cancer Care - Cancer Network
"What is more promising about this study was the utility in all of the cancers studied (ovarian, cervical, breast, testicular, and lung), demonstrating that combining HDAC inhibitors with other therapies may be clinically useful in multiple types of malignancies."
US Oncology picks up Cure magazine - Medical Marketing and Media
Cure magazine is located on the web at www.curetoday.com
Tumour Microenvironment The ‘low oxygen’ environment of solid tumours is leading to a new class of therapies and Measuring Tumour Hypoxia and Tumour Metabolism
Tumour Microenvironment The ‘low oxygen’ environment of solid tumours is leading to a new class of therapies and Measuring Tumour Hypoxia and Tumour Metabolism
Muslim women and medical students in the clinical encounter Medical Education
Medical Education 2010: 44 : 306–315
"Context Increasingly, male medical students report being refused by female patients, particularly in obstetrics and gynaecology, which is impacting on recruitment into the discipline. However, little has been documented in terms of Muslim patients and medical students in the clinical consultation."
Burnout and engagement among resident doctors in the Netherlands: a national study.
Conclusions: "As more than a fifth of the medical residents who responded could be diagnosed as suffering from burnout, we conclude that this problem needs addressing in the Dutch health care system, especially given that a relationship was proven between burnout and suboptimal patient care."
Variation at 8q24 and 9p24 and risk of epithelial ovarian cancer
"Abstract: The chromosome 8q24 region (specifically, 8q24.21.a) is known to harbor variants associated with risk of breast, colorectal, prostate, and bladder cancers. In 2008, variants rs10505477 and rs6983267 in this region were associated with increased risk of invasive ovarian cancer (p < 0.01); however, three subsequent ovarian cancer reports of 8q24 variants were null.........These results indicate that the SNPs studied here are not related to risk of this gynecologic malignancy and that the site-specific nature of 8q24.21.a associations may not include ovarian cancer."
Comment regarding Pelvic Exams while under Anesthesia
My comment: While Lynn's abstract is interesting, it is noteworthy again that these are not new issues as per the included references. I would disagree that further research is required. A root cause analysis is not going to add anything further to what has already been demonstrated. It is now a matter of policy.
“Come here. I want you to feel a normal rectum. Do it.”
Disposition of soy isoflavones in normal human breast tissue - American Journal of Clinical Nutrition
Background: Despite decades of research on the relation between soy and breast cancer, questions regarding the absorption, metabolism, and distribution of isoflavones in breast tissue largely remain unanswered.
Revisiting biographical disruption: Exploring individual embodied illness experience in people with terminal cancer
"Biographical accounts of illness offer useful insights into the social and adaptive processes of living with chronic illness. Yet there are concerns that the underlying theoretical assumptions of a reflexive self seeking to maintain meaning may not reflect the lived experience of individuals....We discuss the possibilities for new approaches to clinical assessment and management of need."
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