Authors
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Clinical Trial Disclosure and Data Transparency: Obligation or Opportunity?Implementing disclosure and data transparency policies and procedures represents an opportunity for sponsors, rather than an obligation.
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Rapid and Scalable Real-World Evidence Generation with Study Automation PlatformsSonja Wustrack, OM1, highlights a new clinical study automation platform to support critical data collection and real-world evidence.
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Augmenting Single Arm Oncology and Rare Disease Trials with Real World EvidenceRWE can augment, extend, or enrich the findings from clinical trials to provide valuable evidence to support the development programs for product approvals.
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Understanding the Complexities of Diversifying Clinical TrialsTufts Center for the Study of Drug Development and Biogen recently conducted a study to inform growing interest in improving diversity of clinical trial participation. The results of this research provide insights into increasing the community of minority investigators and study staff and presenting greater access to clinical trials among minority study volunteers.
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The Rise of Gene Therapy: Advanced Regulatory, Site, and Enrollment ConsiderationsDeveloping new pathways to overcome study-related challenges is key to realizing the promise of the latest gene therapies.
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A Biosafety Perspective on Operational Challenges in Cell and Gene Therapy StudiesThe benefits of working with an institutional biosafety committee in CGT research.
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Leveraging Data Insights to Address the Perils of Linear Practices in Site Identification and ActivationPhesi and Tufts CSDD share results from research on operating practices that can be improved.
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Executing Trial Design With Patients—Not For PatientsApproaching protocol design and operational planning with patient empathy.
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Clinical Trials and TrustUnderstanding the role of social determinants on clinical trial participation and trust.
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Virtual Medical Affairs Audits: A Viable AlternativeVirtual audits proving to be beneficial post-COVID despite continuing challenges.
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Introducing PALADINFirst-of-its-kind consortium dedicated to accelerating new medicines development through optimizing patient advocacy group—industry collaboration.
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Patients Are at the Heart of Cell and Gene TherapyIf you are an organization content with patient-centric approaches, you are behind. Today it is about patient-driven drug development.
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The ICR-CRM-IQVIA Research Network Collaboration ExperienceA discussion of the impact of a strategic alliance in to facilitate operational success at the clinical trial site level in Malaysia.
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Assessing Sponsor Attitudes Toward Retail Pharmacy Involvement in Clinical Trial Recruitment and ExecutionAmid CVS’ surprise exit from the clinical research space and the ensuing broader questions, study investigates the benefits of pharmacy chain involvement—along with the concerns and barriers to adoption.
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Consent Management: Moving Beyond Simple eConsentProviding patients with more flexibility in how they choose to participate in trials.
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Consequences of Brexit for Clinical Trials in EuropeHigher costs headline list of new challenges faced by CROs and sponsors.
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Optimizing Patient Recruitment and Engagement StrategiesFive strategies to reduce risk and achieve deadlines.
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Fast Track Implementation of eConsent: COVID-19 Paves the Way for Virtual TrialsAs many countries slowly progress with the “New Normal,” researchers and healthcare providers are assessing digital/virtual approaches that could reinstate clinical trials.
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Battling ‘Sludge’ in Clinical Trials: A Call to ActionThe concept of sludge provides an invaluable lens for clinical research professionals in identifying and mitigating unnecessary friction and bottlenecks.
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Gender Bias in the Clinical Evaluation of DrugsPast decades have shown gender-based differences in clinical trial results are often overlooked when considering safety and effectiveness.
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Accelerating Clinical Trials in the EUThe ACT EU initiative aims to develop the European Union further as a competitive center for innovative clinical research.
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The Problem with Decentralized Clinical Trials and How to Solve for SuccessWed, Sep 7, 2022 11:00am EST | 8:00am PST | 4pm BST | 5:00pm CEST Decentralized Clinical Trials (DCT) is one of the hottest buzzwords in Life Sciences and Connected Health organizations today. Like any new approach, challenges and roadblocks are common and knowing how to solve for them will empower your organization to accelerate your trial deployment, speeding return of results and time to market.
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Pitfalls to Avoid with Clinical AdjudicationInvolvement of clinical endpoint committees in the adjudication process can improve reliability and robustness of data.
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Characterizing Clinical Data Management Challenges and Their Impact2020 Tufts CSDD – IBM Watson Health benchmarking study highlights need for new functionality from EDC solutions and providers.
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‘Upskilling’ Your Workforce to Keep Pace with ChangeThe DCT-driven evolution requires new levels of understanding and expertise.
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Considering Patient Burden in OncologyImplementing new strategies with the use of patient-reported outcomes.
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An Examination of the Role of the Clinical Research Associate and Factors Impacting Performance and ExperienceStudy by Tufts CSDD uncovers potential reasons behind CRA shortages, turnover, experience requirements, and more.
