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Inside the Mind of the DMC: A Review of Principles and Issues with Case Studies.

Ther Innov Regul Sci

December 2024

The Biostatistics Center, Milken Institute School of Public Health, The George Washington University, Rockville, MD, USA.

A data monitoring committee (DMC) can have an extremely challenging job. Stop a trial too soon, and results are inconclusive and the trial fails to obtain answers to important questions that could inform future clinical practice. Stop a trial too late, and trial participants are exposed to potentially harmful or ineffective interventions longer than necessary.

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Article Synopsis
  • - The study investigates social prescribing in the UK, analyzing a large dataset of over 160,000 individuals to understand referral routes and the effectiveness of interventions aimed at addressing social determinants of health.
  • - Mental health was the primary reason for referrals, with most coming from healthcare providers; however, non-medical routes were found to reach underserved demographics more effectively.
  • - Despite 90% of referrals leading to engagement with a link worker, only 38% resulted in actual interventions, highlighting a shortage of community activities and uneven implementation across the UK.
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Objective: Conduct a systematic review and meta-analysis of the efficacy of therapeutic plasma exchange (TPE) or intravenous cangrelor to prevent thromboembolism in patients with heparin-induced thrombocytopenia (HIT) who undergo cardiopulmonary bypass (CPB) with heparin.

Design: Systematic review and meta-analysis.

Setting: N/A.

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Objectives: Resveratrol has been studied as a potential agent for treating rheumatic conditions; however, this compound suppresses glucose synthesis and glycogen catabolism when infused in perfused livers of both arthritic and healthy rats. This study investigated the effects of oral administration of resveratrol on inflammation and liver metabolism in rats with arthritis induced by Freund's adjuvant, which serves as rheumatoid arthritis model.

Methods: Holtzman rats, both healthy and exhibiting arthritic symptoms, were orally treated with resveratrol at doses varying from 25 to 500 mg/kg for a 5-day period preceding arthritis induction, followed by an additional 20-day period thereafter.

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  • The study examined the effectiveness and safety of reducing linezolid doses in a treatment regimen for adults with pre-extensively drug-resistant or treatment-intolerant multidrug-resistant tuberculosis.
  • Patients were enrolled in a clinical trial where they were randomly assigned to three different dosing regimens of linezolid, alongside bedaquiline and pretomanid, for a total duration of 26 weeks.
  • Results showed that the reduced dose of linezolid (300 mg/day) maintained similar cure rates as the standard dose (600 mg/day) while leading to fewer reported cases of peripheral neuropathy, suggesting a safer approach for treating this condition.
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