Reporting of Randomized Controlled Hodgkin Lymphoma Trials Found Unsatisfactory
A new study says that researchers have not improved reporting of randomized controlled trials, despite guidelines developed 10 years ago. Papers published both before and after guidelines set out by the CONSORT (Consolidated Standards for Reporting Trials) statement, created in 1996, were missing major items needed for readers to evaluate the study.
Thilo Kober, Ph.D., of the Cochrane Haematological Malignancies Group in Cologne, Germany, and colleagues analysed 242 published reports of randomized controlled trials in Hodgkin lymphoma patients published from 1996 to 2002. Reports were grouped into two pre-CONSORT time periods (1966-1988 and 1989-1995), and one post-CONSORT time period (1996-2002).
In all three time periods, 75% or more of the studies only addressed 6 of the 14 criteria based on the CONSORT statement. Items necessary to evaluate the quality of the methods used by researchers were reported in fewer than 20% of the studies. The authors consider the overall level of reporting in randomized controlled trials on Hodgkin lymphoma unsatisfactory.
The authors write, "The CONSORT Statement and checklist is one major initiative to facilitate clear reporting and to provide more transparency in the way in which research results are conveyed in biomedical journals. Thus, our findings strongly support making use of the CONSORT checklist mandatory for all authors reporting on [randomized controlled trials]."
Contact: Thilo Kober, firstname.lastname@example.org
Bach Model Slightly Underestimates Smokers’ 10-Year Lung Cancer Rates in ATBC Study
New data suggest that a lung cancer risk model used to predict a smoker's risk of developing lung cancer underestimates the observed lung cancer risk over a 10-year period.
Kathleen A. Cronin, Ph.D., of the National Cancer Institute in Bethesda, Md., and colleagues examined the ability of a model developed by Peter B. Bach, et al., to predict cancer rates in 6,239 smokers in the in the control group of the Alpha-Tocopherol, Beta-Carotene Cancer Prevention (ATBC) study. They compared actual rates of cancer to rates predicted by the Bach model for 10 years.
The authors observed that the number of lung cancers predicted by the Bach model was lower than the actual number of lung cancers seen. For example, the underestimation was greater for men who smoked under 20 cigarettes a day. The ability of the model to distinguish between low and high risk smokers was similar to that originally reported and comparable to other cancer risk models. The authors suggest that some of the differences between the model's projections and what was seen in the ATBC study might have been due to routine screening, which would lead to more cancers being discovered.
Contact: NCI Press Officers, 301-496-6641, NCIPressOfficers@mail.nih.gov
Modified Adenovirus Can Kill Glioma Cells
An enzyme that directs adenovirus function, called hTERT-Ad, can be used to selectively kill malignant brain tumor cells and other cancer cells containing an enzyme called telomerase, by causing the cancer cells to digest themselves and die, according to a new study.
Seiji Kondo, M.D., Ph.D., at the M.D. Anderson Cancer Center in Houston, and colleagues investigated how replicating adenoviruses (CRAds) selectively target and induce death in cancer cells. They infected gliomas, as well as cervical and prostate cancer cells with CRAds regulated by hTERT-Ad. The authors found that hTERT-Ad infected malignant glioma cells or other telomerase-positive cancer cells and caused them to undergo a process of cell death.
Contact: Laura Sussman, M.D. Anderson Cancer Center, 713-745-2457, email@example.com
Minimally Invasive Technologies to Examine Endpoints in Phase I Trials
Increased use of minimally invasive technologies, such as positron emission tomography (PET) and magnetic resonance spectroscopy (MRS), may help scientists better understand how drugs in phase I clinical trials work in the body and interact with target cells, a review suggests. The authors propose that these technologies be developed further.
Currently, phase I clinical trials of new drugs often do not include basic information about how the drug works in the body. Based on several years experience with clinical trials in the UK, Paul Workman, Ph.D., of the Institute of Cancer Research in Sutton, and colleagues review a number of methods that could be used to examine how a drug is absorbed, metabolized, and eliminated by the body, as well as what it does to the body. The authors suggest that more money should be invested in developing minimally invasive technologies, to improve the speed and quality of drug development.
Contact: Nadia Ramsey, Institute of Cancer Research, 44-20-7153-5359, firstname.lastname@example.org
Also in the May 3 JNCI:
Note: The Journal of the National Cancer Institute is published by Oxford University Press and is not affiliated with the National Cancer Institute. Attribution to the Journal of the National Cancer Institute is requested in all news coverage. Visit the Journal online at http://jncicancerspectrum.oxfordjournals.org/.
Last reviewed: By John M. Grohol, Psy.D. on 21 Feb 2009
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