• Regulatory NewsRegulatory News

    UK Seeks to Increase Clinical Trials Transparency

    The UK government issued a policy paper to improve clinical trials transparency in response to 10 recommendations a House of Commons Science and Technology committee report offered in 2018. “Research findings must be communicated in ways that are timely, meaningful and relevant to evidence users,” Parliamentary Under-Secretary of State for Health Baroness Blackwood said, welcoming the chance to address the October 2018 report . “Only with a system which values transpar...
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    FDA Drafts Guidance on Developing Drugs for Rare Chronic Digestive Disorder

    The US Food and Drug Administration (FDA) issued draft guidance on Wednesday to aid sponsors in the clinical development of drugs and biologics for the treatment of eosinophilic esophagitis (EoE). The 13-page draft guidance document describes the agency’s clinical trial recommendations for EoE drugs. These relate to trial population and design, safety and efficacy considerations, clinical outcomes assessments, as well as pediatric considerations. The clinical developmen...
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    Half of Clinical Trials Fail to Publish Results, UK Report Finds

    Despite UK and EU rules aimed at boosting clinical trials reporting and transparency, a new report by the UK House of Commons’ Science and Technology Committee finds that nearly half of clinical trials fail to publish results.   “Around half of clinical trials are currently left unreported, clinical trial registration is not yet universal in the UK and reported outcomes do not always align with the original study proposal,” the report finds.   Based on these findin...
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    FDA Inspection Finds Minnesota Hospital Violated Informed Consent, IRB Rules

    In an inspection report obtained by Public Citizen, the US Food and Drug Administration (FDA) cites the Hennepin County Medical Center over its institutional review board’s (IRB) oversight of clinical trials that involved dosing emergency patients with ketamine and other sedatives without the patients’ consent.   The inspection, which ran from 7-24 August, came after the Star Tribune reported on clinical trials conducted by the hospital and just weeks after Public C...
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    Industry Proposes Changes to FDA’s FIH Expansion Cohort Guidance

    Industry and oncology groups are calling for changes to the US Food and Drug Administration’s (FDA) recently released draft guidance on first-in-human clinical trials for oncology drugs that feature multiple expansion cohorts.   The 17-page draft guidance, released in August 2018, provides recommendations to sponsors on the design and conduct of such trials, which the agency says can “expedite development by seamlessly proceeding from initial determination of a poten...
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    FDA Finalizes Guidance on Targeted Therapies in Rare Genetic Subsets

    The US Food and Drug Administration (FDA) on Monday finalized guidance on developing targeted therapies in rare molecular subsets of diseases.   The 9-page guidance finalizes a draft version released in December 2017 and has been updated to incorporate comments submitted to the public docket and includes minor edits to improve clarity.   “By providing clarity on the regulatory and scientific frameworks for product developers, safe and effective targeted treatment...
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    Clinical Trials: FDA Releases Two Draft Guidances

    The US Food and Drug Administration (FDA) on Friday unveiled two draft guidances focused on adaptive clinical trial designs and master protocols for cancer treatment trials. Adaptive Trials The 32-page adaptive design draft guidance describes the principles for designing, conducting and reporting the results from an adaptive clinical trial. The draft also advises sponsors on the types of information FDA needs to evaluate the results from trials with adaptive designs,...
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    FDA Finalizes Guidance on PRO Assessment Tool for COPD Trials

    The US Food and Drug Administration (FDA) on Monday finalized guidance to help sponsors developing drugs to treat chronic obstructive pulmonary disease (COPD) to use the St. George’s Respiratory Questionnaire (SGRQ), a patient-reported outcome measure (PRO) assessment tool, in clinical trials. The 8-page guidance, which was revised in draft form in May 2016, notes that sponsors can can use the SGRQ as a PRO assessment of efficacy in submissions to investigational new ...
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    Regulatory Challenges for Direct-to-Patient Clinical Trials

    p> On-site clinical trials may present a number of participation obstacles for individuals living at distances from clinical trial sites or for patients with mobility problems. Direct-to-patient clinical trials can be an alternative. This article reviews applicable regulations and analyzes current strategies for conducting direct-to-patient clinical trials using technologies, such as mobile 'apps' and wearables to report data, as well as the potential for sending trial dr...
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    Asia Regulatory Roundup: TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines (19 December 2017)

    Welcome to our Asia Regulatory Roundup, our weekly overview of the top regulatory news in Asia. TGA Resists Industry Pressure to Change Adverse Event Reporting Timelines Australia’s Therapeutic Goods Administration (TGA) has finalized its timelines for reporting adverse events involving biologicals. The timelines are unchanged from draft guidance published last year that was criticized by companies including Pfizer for giving sponsors too little time to act. Un...
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    CDRH Sees Spike in Pre-Market Submissions With Patient-Reported Outcome Measures

    The US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) on Tuesday issued its first report on patient-reported outcomes (PROs), noting a significant uptick in PRO data submitted in 2017. Over a six-year period, the report says CDRH observed a more than 500% increase in the number of pre-market submissions that include PRO measures. And in FY 2017, more than 75% of approved, pivotal original and new study investigational device...
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    French Regulators Set Up Dedicated Unit for Overseeing Early Stage Clinical Trials

    France's Agence Nationale de Sécurité du Médicament et des Produits de Santé (ANSM) last week announced that it is setting up a new unit dedicated to overseeing first-in-human and other early stage clinical trials. The new unit is part of ANSM's action plan created in response to an incident during a first-in-human trial in France that left one patient dead and five others hospitalized in early 2016. The incident sparked an investigation by ANSM and a led to the Europe...