After more than a decade of facing barriers, direct-to-patient (DTP) shipment of investigational products is coming into its own now that pandemic conditions have prompted solutions to major transportation problems. Sites and sponsors now have more DTP options, but there are still some kinks to work out and regulatory guidance needed.
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Sites, sponsors and IRBs all agree that informed consent forms (ICF) need to be shorter, less technical and more readable for the lay person, but there can be tradeoffs in any kind of change. Explaining medical terms in plain language requires more words, adding to the length of the document. Removing legalese can make ICFs shorter but may leave a sponsor open to liability issues.
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In an effort to broaden the eligibility criteria of noncurable cancer trials, the FDA has published final guidance recommending that sponsors and investigators allow patients who have not taken existing treatment options to participate.
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The European Medicines Agency (EMA) has seen a modest but steady rise in the number of trial applications submitted to its new Clinical Trial Information System (CTIS) since the platform launched on Jan. 31.
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It’s not just academia- and industry-funded trials that are lacking in transparency; a recent audit by the Office of Inspector General (OIG) has found that the National Institutes of Health (NIH) failed to ensure that the results of the trials it funded were posted on ClinicalTrials.gov in line with federal reporting requirements.
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An herbal medicine specialist operating trials as a sponsor-investigator has been hit with an FDA Form 483 after a March inspection found she had skipped the investigational new drug (IND) approval, IRB review and informed consent processes in two trials for COVID-19 treatments.
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