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A single trial design misstep can halt a product’s clinical progression, while an informed clinical strategy, which leverages input from patients, regulators, site staff, and other stakeholders, can help teams improve decision-making and outcomes. Join Clinical Leader Live on June 14th as we bring together veteran drug developers to discuss what to do, and what not to do, when designing a clinical trial protocol.
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Advancing Innovative Therapies For Mild-To-Moderate Psoriasis With Novel PASI-HD Assessment
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Guest Column |
By Kim A. Papp, MD, Ph.D., FRCPC, Probity Medical Research
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The Psoriasis Area and Severity Index, or PASI, was developed in the 1970s as a tool for assessing the severity of psoriatic lesions for the purpose of assessing outcomes in a psoriasis clinical development program. But it falls short in assessing the severity of the disease in those with mild to moderate psoriasis. Enter PASI-HD.
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A New Avenue In Breast Cancer Therapeutics
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Article |
By Elizabeth Lamont, Medidata, and Paolo Tarantino, European Institute of Oncology and Clinical Research Fellow at the Dana-Farber Cancer Institute
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New clinical trial findings may have unlocked a groundbreaking opportunity for breast cancer patients: beneficial therapy for HER2 negative patients with HER2-directed antibody-drug conjugates.
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How Do Clinical Trials Find Patients Online?
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White Paper |
Trialbee AB
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Thanks to new tools and solutions trial recruitment and enrollment have gotten easier. However, delve into why the technology raises questions and concerns around data privacy.
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Cognition Therapeutics, Inc. is seeking qualified vendors to bid for federal grant-funded activities for the remainder of 2023. Cognition has two immediate needs: 1) vendors who can assist with Phase II recruitment in neurodegenerative diseases, 2) vendors with expertise in data management (STDM, TLF, CSR), statistical analysis plans, and final analysis. To submit your company's qualifications, please visit www.cogrx.com/contracting-opportunities and complete a preferred vendor qualification form by 11:59 p.m. on May 22, 2023.
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Signal Management In Pharmacovigilance (Virtual: June 12-15, 2023)
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DIA Global's upcoming short course offering, Signal Management in Pharmacovigilance, covers essential concepts of signal detection and signal management and provides guidance on how to apply these concepts at participants' functions and their organization, including the data mining techniques for large volume ADR data analysis. There are only a few seats left, so be sure to register today!
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You're receiving the Monday edition of the Clinical Leader newsletter, focusing on Clinical Sites, Patient Centricity, and Patient Recruitment. To make changes to your newsletter selections, update your topic preferences.
- Clinical Sites | Patient Centricity | Patient Recruitment (Monday)
- Clinical Trial Technology (Tuesday)
- Decentralized Trials | Trial Management (Wednesday)
- Outsourcing Models | Regulatory & Compliance (Thursday)
- Clinical Data Management & Analytics | Trial Monitoring (Friday)
Learn more about our personalized newsletters here.
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