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Over the past 15 – 20 years, projected peak sales and return on investment (ROI) of new drugs has been shrinking (source: Statista and Deloitte Centre for Health Solutions). To offset this, pharmaceutical companies are pushing to get more drugs to market and multiple indications for each agent.
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Decentralized clinical trials (DCT) seems to have burst on to the scene in just the last few years, so it is easy to get swept up into how we can best implement them into our clinical trials. However, it is worth examining the past of this supposedly “new” method of conducting clinical trials.
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“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives. We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”
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“PROMETRIKA invites you to read and enjoy a two-part blog series on risk-based monitoring (RBM) and the different clinical trial monitoring approaches based on our clinical operations team’s experience and research objectives. We will explore the differences between the traditional 100% source document verification (SDV) approach and RBM through the lens of two hypothetical clinical research associates (CRAs) as told in the style of an afternoon soap opera.”
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The thinking on monitoring of clinical studies has been changing over the past several years, so now is a good time to reassess the place of SDV and SDR in the operation of clinical trials.
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