Clinical trials in New Zealand--treading water in the knowledge wave? (original) (raw)

2005, The New Zealand medical journal

To describe the number and type of clinical trials in New Zealand 1998-2003, and to identify the number of trials for which approval was sought in 2003 that were listed with trial registries. Annual reports (1998-2003) from all regional ethics committees were reviewed for clinical trials. Trials must have been referred to as phase I, II, or III clinical trials; employ descriptors such as randomised controlled trials or controlled trials; or been known to the authors as randomised controlled trials. Trials registers at ClinicalTrials.gov, Current Controlled Trials, NHMRC Clinical Trials Centre, National Cancer Research Network, CenterWatch, Trans-Tasman Radiation Oncology Group, as well as industry registers were searched using keyword identifiers for the trials submitted for ethical review in 2003. Ethics approval was sought for 665 clinical trials (1998, 118 trials; 1999, 91 trials; 2000, 103 trials; 2001, 104 trials; 2002, 108 trials; 2003, 141 trials). The majority of application...

Clinical trials in NZ: does anybody know what's going on?

The New Zealand medical journal, 2002

Clinical trials are the best method for determining which treatments are effective. Although some treatments have very obvious benefits, most have modest effects. It is in these common circumstances that randomised controlled trials (RCTs) are needed to distinguish real effects from the influence of biases. The recent hormone replacement therapy story is one of many examples in which non-randomised studies have proved to be seriously misleading. 1

Trials with patient-reported outcomes registered on the Australian New Zealand Clinical Trials Registry (ANZCTR)

Quality of life research : an international journal of quality of life aspects of treatment, care and rehabilitation, 2018

It is important to understand the number, types and regions of trials that include patient-reported outcomes (PROs) to appreciate how patient experiences have been considered in studies of health and interventions. Twenty-seven percent of trials registered with ClinicalTrials.gov (2007-2013) included PROs; however, a regional breakdown was not provided and no reviews have been conducted of the Australia New Zealand Clinical Trials Registry (ANZCTR). We aimed to identify trials registered with ANZCTR with PRO endpoints and describe their characteristics. ANZCTR was systematically searched from inception (2005) to 31 March 2017 for trials with PRO endpoints. Search terms included PRO measures listed in Patient-Reported Outcomes Quality of Life Instrument Database and Grid-Enabled Measures, as well as generic PRO terms (e.g. "quality of life" (QOL)). Trial endpoints were individually coded using an established framework to identify trials with PROs for the analysis. Of 13,666...

Reviewing Clinical Trials: A Guide for the Ethics Committee

Medicina (Buenos Aires), 2010

proposed the project for an ethics guide. The first question raised was: "Why approach The University of Hong Kong and not a leading medical institution in the US or in Europe?" The reply was: "Because of the monthly newsletter that you produce, i.e., the Clinical Trial Magnifier," (http://www.ClinicalTrialMagnifier.com), which may be a valid reason, after all. The project has been a great challenge but also an honour. The final product fits well with the mission of the Clinical Trials Centre as one of the leading academic research organisations in Asia, in line with the mission of the Association for the Accreditation of Human Research Protection Programs, Inc., Washington, DC, the sole non-profit human research accreditation organisation in the US. Once we agreed to consider the invitation, we arranged a phone conference with ten senior Pfizer global staff to discuss the overall objective of the project. It became clear that there was a large worldwide demand for educating ethics committee members on how to review clinical trial protocols, especially in health care organisations outside the leading academic institutions in emerging clinical trial locations, including Brazil, China, India and Russia, but also in other emerging regions such as Argentina,

Experiences in Review of Clinical Trials

2014

The purpose of an IHEC (Institutional Human Ethics Committee) review is to ensure that appropriate steps are taken to protect the rights and welfare of participants as subjects of research. If the risks to participants are found to be too great, the IHEC will not approve the research, or it will specify changes that must be made before the research can be done. The EC (Ethics committee) review process of a trial protocol includes three different considerations: science, ethics and data quality. Any clinical trial with poor science, poor ethics or poor data quality puts participants at unnecessary risk of harm. This study aims to list out the scientific and ethical issues identified during review of clinical trials at IHEC. On IHEC approval, all the clinical trials approved over the past five years in IHEC, were analyzed using a proforma by the investigators (1-3) who are IHEC members & the anonymized raw data was given to the investigator number 4 who is not an IHEC member. 33 clini...

Publication trends of clinical trials performed in South Africa

Background. Investigators and sponsors of clinical trials have an ethical obligation to disseminate clinical trial results, whether positive or negative, in a timely manner. Objectives. To determine the publication rate and average time to reporting for clinical trials carried out in South Africa (SA) and to explore factors indicating whether a study is published or not. Methods. A registry-based quantitative retrospective analysis of 79 SA clinical trials for new medicines registered between January 2008 and December 2010 was performed. The relevant trial identification number in the register was used to track all peer-reviewed publications subsequent to registration. Tracking of clinical trials was done through a systematic literature search of the electronic journal databases of the South African Medical Journal (SAMJ), the Cochrane Library, Public Library of Science Medical Journal (PLoS Medicine) and BioMed Central, all of which are indexed on MEDLINE via PubMed. In addition, a manual search of the Open Access Journal of Clinical Trials databases and reference lists on articles related to the trial medicine was performed. Results. Of the 79 clinical trials surveyed, 72 were concluded by December 2014. Only 35 (48.6%) of them had the results published in a peer-reviewed journal, the current benchmark for dissemination of trial results. The majority (82.9%) of those published had a positive outcome. Of the 35 trials that were published, 77.1% were published within 2 years. The average time from completion to initial reporting was 22 months. Fewer than half (40.5%) of the clinical trials surveyed were placebo controlled. Conclusion. The absence of complete outcomes data from SA clinical trials warrants utmost attention. The study puts forward a case to the regulatory body and research ethics committees to compel all data from clinical trials to be made accessible to clinicians and the public in general by being published in an easily accessible form and in a timely manner.

The natural history of conducting and reporting clinical trials: interviews with trialists

Trials, 2015

Background: To investigate the nature of the research process as a whole, factors that might influence the way in which research is carried out, and how researchers ultimately report their findings. Methods: Semi-structured qualitative telephone interviews with authors of trials, identified from two sources: trials published since 2002 included in Cochrane systematic reviews selected for the ORBIT project; and trial reports randomly sampled from 14,758 indexed on PubMed over the 12-month period from August 2007 to July 2008. Results: A total of 268 trials were identified for inclusion, 183 published since 2002 and included in the Cochrane systematic reviews selected for the ORBIT project and 85 randomly selected published trials indexed on PubMed. The response rate from researchers in the former group was 21% (38/183) and in the latter group was 25% (21/85). Overall, 59 trialists were interviewed from the two different sources. A number of major but related themes emerged regarding the conduct and reporting of trials: establishment of the research question; identification of outcome variables; use of and adherence to the study protocol; conduct of the research; reporting and publishing of findings. Our results reveal that, although a substantial proportion of trialists identify outcome variables based on their clinical experience and knowing experts in the field, there can be insufficient reference to previous research in the planning of a new trial. We have revealed problems with trial recruitment: not reaching the target sample size, over-estimation of recruitment potential and recruiting clinicians not being in equipoise. We found a wide variation in the completeness of protocols, in terms of detailing study rationale, outlining the proposed methods, trial organisation and ethical considerations. Conclusion: Our results confirm that the conduct and reporting of some trials can be inadequate. Interviews with researchers identified aspects of clinical research that can be especially challenging: establishing appropriate and relevant outcome variables to measure, use of and adherence to the study protocol, recruiting of study participants and reporting and publishing the study findings. Our trialists considered the prestige and impact factors of academic journals to be the most important criteria for selecting those to which they would submit manuscripts.

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