FDA draft guidance and clinical trials

In 2015, the Food and Drug Administration released the Clinical Trial Imaging Endpoint Process Standards draft guidance for the clinical trial industry. According to the FDA, the purpose of the guidance is to assist sponsors in optimizing the quality of imaging data obtained in clinical trials intended to support approval of drugs and biological products. More specifically, […]

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To be or not to be… compliant

There are a number of challenges when designing and building solutions for the collection and delivery of image submissions for clinical trials. One of them is compliance with global regulations governing the process. While regulations set forth by agencies such as the FDA, HIPAA, and their equivalents in Europe and Asia can be complicated, and […]

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Should BMW focus their R&D on developing new stereo systems?

There is a lot more riding on the success of an imaging trial today than ever before. The world economy, mergers and acquisitions, the state of sponsors’ pipelines and changes in the regulatory environment, have created the most demanding market for clinical trials ever. One of the results of this evolution is the increased focus […]

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Clinical trial site queries: How many do we have to live with?

If you look at a typical proposal for the management and data analysis of image data in clinical trials, there is always a budget item related to site queries. Queries can be generated for a variety of reasons, ranging from missing data (e.g., a missing timepoint) to incongruences within a single submission (e.g., different documents […]

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The power of notifications in trials with image-based eligibility criteria

  We are seeing more and more imaging trial protocols requiring the analysis of subject eligibility to occur under tightening deadlines. Take for example a cardiovascular study using centralized analysis of an Intra-Vascular Ultrasound (IVUS) to determine whether a subject should be included in the trial. In this particular protocol, the patient remains in the […]

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Is site submission quality less important than data analysis?

Clinical trial sponsors have focused for years on finding the right investigators who can recruit patients, and choosing the best core laboratories to do the necessary data analysis. Without a doubt, having the best thought leaders associated with a trial can increase the level of success (defined as pursuing the right path and abandoning the […]

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Patient privacy regulations and Part 11: How do they relate?

In the world of clinical trials, we are constantly reminded of national privacy regulations and 21 CFR Part 11 restrictions when using electronic means to submit medical imaging data. National regulations (NRs) include the European Union Directive on Data Privacy, The Canadian Personal Information Protection and Electronic Documents Act (PIPEDA), HIPAA, OECD and their equivalents […]

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Batching image submissions in clinical trials: the case against it!

Clinical trials are inherently risk management exercises, where sponsors, CROs and investigators work as a team to determine the effectiveness of a compound or treatment. In the late 1900s, form data submitted by investigators to CROs was sent using the latest in technology: fax. Prior to that, forms were mailed. The advent of EDC systems […]

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The balance between privacy and drug discovery

In 2011, Forbes published a somewhat startling article about HIPAA violations in the U.S. The gist  of the piece is that violations are occurring more than one might think, that data that people consider to be non-confidential details are in fact protected by law, and that organizations are being successfully sued for millions of dollars […]

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Cloud infrastructure in imaging trials: the need for quality

In an interesting interview in Bio.IT World, Glen DeVries, president of Medidata Solutions, spoke about the evolution of clinical trial processes and how we’re inevitably going toward cloud solutions. I couldn’t agree more. As Glen points out, we’ve seen this phenomenon across a multitude of industries: The advent of good software packages moved things from […]

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