New signpost to clinical trial expertise
Taking a cue from the way drugs like Viagra put the biological brakes on a key enzyme involved in heart failure, scientists at Johns Hopkins have mapped out a key chemical step involved in blocking the enzyme. The Johns Hopkins team reports how the enzyme, phosphodiesterase 5, or PDE5A, slows down the breakdown of another,
Full Post: Scientists map steps to block enzyme phosphodiesterase 5’s action in heart failure
A new comprehensive online resource listing national expertise in the design and conduct of clinical trials is launched today. The UKCRC Registered Clinical Trials Units website provides, for the first time, centralised information on Clinical Trials Units (CTUs) in the UK - including the Bristol Randomised Trials Collaboration (BRTC) at the University of Bristol.
The new website will be a valuable resource for clinical researchers and funders wishing to identify CTUs that can help them to design and run high quality trials for the benefit of patients. It has been developed and funded by the National Institute for Health Research (NIHR) Clinical Research Network Coordinating Centre on behalf of the UKCRC Partners.
Developing and running a clinical trial is a complex process and CTUs are specialist units that bring together the experts needed to design, manage and analyse a trial. These include clinicians, statisticians and trial managers who together ensure that clinical trials are conducted in line with appropriate standards and regulations.
The Bristol Randomised Trials Collaboration (BRTC) is one of forty CTUs listed on the website, all of which have achieved UKCRC Registration status.
BRTC is a long-standing collaboration between the University’s Departments of Community Based Medicine and Social Medicine in the design and conduct of high quality phase III randomised trials, and provision of training courses in trial methodologies.
Dr Alan Montgomery, Director of the BRTC said: “We conduct trials in both primary and secondary care settings, and in many different disease areas, including mental health, diabetes, child health, and cancer. The methodological expertise within BRTC comprises statistics, economics and social science.
“Areas of particular interest include complex trial design, and the application of social science to improve recruitment, design and conduct. As members of academic departments, our approach is to establish full and formal academic collaboration at all stages of a project, including design, development, conduct, analysis and reporting.”
The new UKCRC Registered Clinical Trials Units website will allow researchers and funders to easily locate CTUs by name or location or find suitable CTUs by disease research areas (eg diabetes, mental health), methodological research areas (eg economic evaluation, systematic reviews and meta-analysis) or specific types of clinical research study (eg surgical trials, trials of investigational medicinal products). CTUs can also be identified by their experience of working with particular funders of clinical research.
Professor Janet Darbyshire, Joint Director of the NIHR Clinical Research Network Coordinating Centre, said “Working with Clinical Trials Units can help to increase the quality of clinical trials which ultimately means that the results are more meaningful. The UKCRC Registered Clinical Trials Units website provides an easy route for researchers and funders to tap into the fantastic experience and expertise that these units provide.”
Dr Liam O’Toole, Chief Executive of the UKCRC, said: “Easy access to the kind of information provided by this website will help researchers and funders, including the pharmaceutical industry, to easily identify CTUs which can help their studies. The launch of this website is part of a range of measures to ensure that the UK is at the forefront of carrying out high quality research for the benefit of patients.”
Neuralstem, Inc. announced this morning that it has filed an Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) to begin a clinical trial to treat amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The Company is planning to treat ALS patients through spinal injections of its stem cells via its
Full Post: Neuralstem files IND for amyotrophic lateral sclerosis stem cell trial
Addressing the nation’s continuing poor performance in cancer clinical trial participation, particularly among racial and ethnic minorities and low income groups, will require meaningful public involvement in the design and implementation of clinical trials, according to a landmark report released today. Despite many previous calls for community participation and engagement, Communities as Partners in Cancer
Full Post: National call for cancer trial system to be more responsive to community needs
Media coverage of clinical trials does not contain the elements readers require to make informed decisions. A comparison of the coverage received by pharmaceutical and herbal remedy trials, reported in the open access journal BMC Medicine, has revealed that it is rarely possible for the lay public to assess the credibility of the described research.
Full Post: Misleading media coverage of clinical trials
GeoVax Labs, Inc. has announced that the launch of its Phase 2a Human Vaccine Trials will take place in twelve sites across North and South America. These trials are conducted in collaboration with The National Institutes of Health (NIH), and the HIV Vaccine Trials Network (HVTN). “It is of significant importance to report this major
Full Post: GeoVax’s HIV/AIDS human vaccine trials to begin in North and South America
The U.S. Food and Drug Administration announced a Class I recall of lot no. UD30654 of Healon D, an ophthalmic viscosurgical device (OVD) manufactured by Advanced Medical Optics Inc. (AMO) of Santa Ana, Calif. OVDs are viscoelastic materials used to maintain space in the eye during surgery. Typically, OVDs are pre-packaged in a syringe and
Full Post: FDA announces recall of ophthalmic viscosurgical device