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Tag Archives: Clinical Trial

Data and Safety Monitoring of Clinical Trials

Randomised clinical trials for medicines and medical devices are progressively being monitored for safety and other interim results by both Sponsors and Contract Research Organisations (CROs). There are a variety of methods to aid in proactive monitoring and gauging of … Continue reading

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Source Documentation – The Eyes of Evidence (Part Two)

In Part One of this blog series, the definition of good source documentation and its importance was outlined. In Part Two, we look at the nature and causes of poor documentation, along with how these can be addressed. Failure to … Continue reading

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Source Documentation – The Eyes of Evidence (Part One)

Interestingly, inadequate and/or inaccurate case histories form the second most commonly cited deficiency in US-FDA inspections of clinical investigator sites, while in Europe, source documentation issues ranked 5th among the top 10 findings from European Medicines Agency (EMA) inspections of … Continue reading

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Your clinical study is only as good as your data

Clinical trials are intended to find answers to research questions by means of generating data for proving or disproving hypotheses. Clinical Data Management (CDM) is critical to the generation of high-quality, reliable, statistically sound data from clinical trials and thus … Continue reading

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The Australian New Zealand Clinical Trials Registry (ANZCTR)

The Australian New Zealand Clinical Trials Registry (ANZCTR) is an online register of clinical trials being undertaken in Australia, New Zealand and elsewhere. The ANZCTR was established in 2005 and is part of a worldwide initiative to make public all clinical trials … Continue reading

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Clinical Trials – A Patient Centred Focus

Patients today aren’t just taking part in clinical trials – they are playing an increasing role in the design and development of clinical trials. This is an important step forward in the clinical trial process. Patient input helps companies better … Continue reading

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The 3R’s of Clinical Trials: Recruitment-Retention-Reward

Did you know that less than 10% of clinical studies are completed on time? In fact, 94% of trials are delayed by over one month. Although this doesn’t sound like a significant delay, it has been estimated that for each … Continue reading

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Clinical Trial Transparency – Less Fog in the Looking Glass

In Nov 2014, the National Institutes of Health (NIH) published a notice of proposed rulemaking that would expand the clinicaltrials.gov registration and results reporting for clinical trials, requiring posting of results for clinical trials of unapproved and uncleared products. This … Continue reading

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What treatment switching means to the future of clinical trials

More and more frequently, treatment switching is occurring in clinical trials, particularly in the area of oncology. Not surprisingly, patients are demanding to be switched (most commonly) from the control treatment arm of a trial to the experimental treatment or … Continue reading

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New FDA draft guidance risks ‘Confused Consent’

Clinical trials require researchers to ensure that each participant is fully aware of the details of the trial before they take part. The FDA’s recently released draft guidance for Institutional Review Boards (IRBs), clinical investigators and sponsors on Informed Consent … Continue reading

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