�Researchers linear cancer trials are a great deal critical of the Research Ethics Committee (REC) work they have to go through to get their trials sanctioned, complaining that it's excessively complex, onerous and sometimes unreasonable. In the UK only 17% of research study applications are apt immediate favorable opinion by RECs.
But a new study from the University of Leicester, recently reported in The Lancet Oncology, suggests that RECs english hawthorn sometimes identify important problems in applications to conduct cancer trials.
The Leicester study, funded by the National Research Ethics Service, looked at 80 anonymised NHS REC decision letters concerning cancer the Crab trials, written between March 2004 and December 2006.
When reviewing applications to conduct cancer trials, the issue RECs are most likely to raise is that of informed consent. Committees are often concerned that the information that researchers propose to give patients may not be in linguistic process that can be easily understood. They also monish researchers from presenting trials too enthusiastically, and seek to prevent researchers from providing shoddy information. One Committee pointed out that the genus Cancer drug side-effects were described as mild on the patient info sheet, just in the investigator's leaflet it was noted that several patients had experienced serious adverse events sentiment to be related to the drug.
The study found that RECs identify a high rate of mistakes in applications, including missing info, ticking the wrong boxes, errors in the info provided and not following correct procedures.
The findings support the conclusion that RECs, though by their constitution slightly bureaucratic, leave an significant independent check on clinical trials by ensuring that investigators do not miss important information or undervalue risks in the information they give patients.
Professor Mary Dixon-Woods, of Medical Sociology in the Department of Health Sciences at the University, commented: "There have been a destiny of complaints about REC procedures from researchers in recent years. They often find the process onerous and bureaucratic. However, this study is the offset time anyone has consistently analysed what RECs are saying approximately cancer trial proposals.
"RECs are looking at for evidence that researchers are sensitive to ethical issues, in particular to participants' interests, and that information disposed to potential participants explains the trial fully and truthfully. Researchers can amend their chances of success at ethical review by really secure preparation."
The study, led by Professor Dixon-Woods, was carried out with Emma Angell, Carolyn Tarrant and Anne Thomas, in the Social Science Research Group in the Department of Health Sciences at the University of Leicester and the Department of Cancer Studies and Molecular Medicine at the Leicester Royal Infirmary.
University of Leicester
More info
Wednesday 3 September 2008
Subscribe to:
Posts (Atom)