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Rare Diseases and the Eye - Envisioning Strategies for SuccessDeveloping therapies and successfully executing clinical trials for rare ophthalmologic disorders present unique challenges, but with these challenges come significant opportunities to employ innovative strategies to drive success. Explore how careful feasibility and novel approaches to patient recruitment can advance the treatment of rare conditions of the eye. Live: Friday, 27 Oct., 2017 | 11 am EDT | 8 am PDT | 1600 BST | 1700 CEST / On Demand available after airing until 27 Oct., 2018. Register free: http://www.appliedclinicaltrialsonline.com/act_w/success
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Clinical Trials in Kazakhstan: Open For BusinessThis brief overview of Kazakhstan presented by Vlad Bogin will help you get acquainted with this emerging clinical trial location.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Interexpert Agreement on Adverse Events’ EvaluationStudy measures the differing judgment levels between clinical investigators and drug safety experts.
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Leverage Site-Owned Tech to Improve Trial RetentionMajor Depressive Disorder patients display a reduced ability to feel pleasant experiences known as Anhedonia. Such a feature provides difficulties when treating depression and engaging patients during clinical trials.
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Orphan Drugs: Market Overview and Country-Specific AnalysisOrphan medicines have become a formidable R&D segment with robust growth that is expected to continue. Expansion is needed to cope with the issues of development and patient recruitment. An understanding of regulations, therefore, is critical.
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New Diagnostic Criteria Narrows the Definition of Parkinson's DiseaseThe Movement Disorders Society has recently published Clinical Diagnostic Criteria for Parkinson’s disease. These new guidelines allow for the diagnosis of clinically established and clinical probable Parkinson’s disease, which will help reduce errors in clinical trials.
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Tips to Get to (and through) FDA Approvals FasterWhile thousands of hours are spent in the hopes of finding more effective treatments, many of them are rejected due to administrative errors. These three tips can help reduce the frequency of common administrative mistakes during clinical trials.
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Regulatory Approval in India: An Updated ReviewIssues concerning the drug approval process in India have occurred in clinical studies resulting in a reduced interest from sponsors. The Drug Controller General of India (DCGI) has been working to amend and update it’s policies to stimulate growth in this sector.
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One Way CROs Can Outshine Their CompetitionThe last piece in our three-part series on improving efficiencies and sponsor/CRO collaboration through advanced CTMS, reveals a way in which CROs can best their competition in the marketplace.
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Early Planning Assures Better OutcomesThe early implementation of post authorization safety studies (PASS) will translate to efficiencies in pre-appoval research. These benefits allow for faster approval and wider patient access to potentially life saving therapies.
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Engagement Shift: Informed Consent in the Digital EraWhy electronic informed consent is key to supporting today’s patient-centric mantra in clinical trials.
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The Evolution of Real-World Evidence: Moving Beyond Claims Data in Clinical TrialsIndustry is turning to enhanced data collection methods in response to high demands for efficiency and profitability.
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The Trial of the FutureClinical trials of the future may be closer than we think as we strive to deliver smarter, faster and more cost effective treatment to patients. The data exists to make this possible, now we must change our thought process to meet the needs of patients and sponsors.
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Janssen Autism Knowledge Engine for Clinical TrialsAutism Spectrum Disorder (ASD) is a common neurodevelopmental disorder which does not have an approved medication to address its core symptoms. The Janssen Autism Knowledge Engine (JAKE) was designed to advance the clinical research process for autism by integrating emerging technologies into traditional clinical trial processes.
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Integrated Scanning: A Key to eTMF EfficiencyEven though sponsors and CROs are working to create more and more documents as electronic originals, scanned paper still comprises a large portion of any given eTMF.
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The Growing Availability of Wearable Devices: A Perspective on Current Applications in Clinical TrialsPilot study evaluates the feasibility of using wearable devices in clinical data collection, including the training requirements for appropriate use of the mHealth technologies and the impact of the model on data quality and patient engagement.
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Expected Changes to the Vendor Landscape in 2018An industry shift has led toward more insourcing and in-house resources to run trials.
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Mining Cancer Kryptonite from Historic Clinical Trial DataClinical trial data from completed trials are now beginning to be shared through a variety of channels. While skeptics remain, evidence is growing that this data can lead to practice-changing behavior in patient care.
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Preparing for the ICH E6 (R2) Addendum: A 3-Part SeriesThis 3-part series provides insight into ensuring compliance with the ICH E6 (R2) Addendum to take effect later this year. Part 3 covers the value of embracing a centralized, technology driven approach to risk based monitoring.
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Generic Drug Repurposing Clinical TrialsGeneric drug repurposing can often create medical solutions regardless of the supporting entity. “Unsolved” diseases can benefit from this strategy despite commercialization challenges.
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Closing the LoopPatient recruitment remains a challenge for both the biopharma industry and the oncology research community. New recruiting platforms in development have the potential to change the way the industry uses technology, data and the internet to augment recruiting efforts.
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Multidisciplinary Approach to Protocol WritingThis article examines the requirements for developing an effective Clinical Trial Protocol, observing that it takes time, commitment, and a full team effort to produce protocols of an acceptable standard.
