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A Closer Look at 1572: Interpreting the FDA's Statement of Investigator FormA new reference guide clarifies uncertainty surrounding this sometimes misunderstood document.
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eClinical Trials: Planning & ImplementationeClinical Trials: Planning & Implementation is a useful resource for those new to the industry as well as practitioners already involved in planning and implementing eClinical trials.
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Centralization of IRB Review Fact of Life Outside of NIHThe idea is great: when an investigator submits a grant to any NIH institute, if the study will involve more that one performance site, the grant must include a plan to rely on one single IRB.
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What Can You Do to Prevent Clinical Trial Fraud?Expert outlines approaches to preventing fraud in clinical research-a more prevalent problem that many believe.
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Forced Randomization: When Using Interactive Voice Response SystemsInteractive voice response systems are commonly used in clinical trials to manage the flow of trial medication supplies to sites and to manage the allocation of these supplies to individual subjects. Other advantages and uses include access to real-time information for trial managers, collection of diary card data directly from subjects, and as an aid to subject recruitment.1
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Searching for a CRO - Can the Internet Help?More than 1000 contract research organizations exist worldwide, and the number is growing. CROs differ widely in size and profile. Before a project can be contracted out, sponsors often spend valuable time searching for the CRO that best fits the project's specifications. Consultants are often needed to help hew a path through this jungle, a task made all the more difficult by the intentional withholding of information that would help sponsors decide. The World Wide Web would be an excellent means for CROs to communicate relevant and fluid information about their companies, and herein I offer a model for CROs to use.
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Lessons from TGN 1412How applying statistics to the design, conduct, and analysis of Phase I trials can improve clinical research.
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A New Paradigm for Biomedical ResearchIn the biomedical research industry, and at Pfizer in particular, we are committed to what we call "The Three As"-making medicines available, accessible, and affordable.
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Using Customer Relationship Management StrategiesAs the number and complexity of clinical trials grows-lengthening clinical trial durations and raising costs-sponsors and CROs need a way to streamline trial management, shorten study durations, and reduce expenditures. Customer relationship management (CRM) strategies update the paper-intensive methods of the past and offer an innovative approach to managing clinical trials-an approach that focuses on strengthening relationships between trial participants, especially investigators and subjects.
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A Closer Look at 1572: Interpreting the FDA's Statement of Investigator FormA new reference guide clarifies uncertainty surrounding this sometimes misunderstood document.
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Stopping a Trial Early for Treatment Benefit: Pros & ConsReal examples from recent studies illustrate the risks associated with making such a delicate decision.
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Pretty Good ProcessesFollowing the examples of these six companies might change your organization for good.
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Taking eCOA Delivery Off the Critical Path to First Patient InStreamlining electronic clinical outcome assessment and patient-reported outcome processes can aid in decreasing timelines.
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Harnessing Patient-Centered Science to Improve Health Outcomes and Commercial Pharma SuccessGood scientific principles and practices are essential for maintaining quality data that patients can benefit from.
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Probing Ethics in Human ResearchPerhaps a way forward is to refocus our efforts on a "culture of conscience," since our conscience often guides our actions.
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Improved Organization and Management of Clinical TrialsThe very first article ACT ever published shows how many changes the CRO industry has seen in 13 years.
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A Clinical Development Solution Tailored for Biopharmaceutical CompaniesThe rapid evolution of the biopharmaceutical industry has lead more and more companies to focus on the clinical development of their drug candidates, thus presenting the challenge of selecting the optimal strategy for conducting their clinical programs. Typically, biopharmaceutical companies have had three options: out-licensing their product, setting up their own clinical development operations, or outsourcing the clinical development to contract research organizations (CROs).
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Archiving Approach in the UKThe proper storage of research documents remains an essential aspect of the clinical trials process.
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Imaging CROs in AsiaImprovements in image acquisition and read quality: A look at the value of standardization in oncology trials.
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Value of Time and MoneyIndustry Standard Research has recently released its 3rd annual "CRO Quality Benchmarking Report." The report not only profiles the delivery quality of leading CROs, but also provides a wealth of information that relates to larger industry trends, including the value of recruitment speed.
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Long-term Electrocardiographic Monitoring: Time to Rethink What We Know?With significant technology advances in ECG recording through the years, the need to expand on traditional monitoring baselines-and include new variables such as time when designing clinical trial protocols-is important.
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Current Challenges of Poor R&DTransfer of material between the supply cahins can be time consuming and complicated
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Clusters' Last Stand?While order might be useful for smaller firms to do business, it is not useful in helping them to innovate.
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Sponsor-Investigator Relationships: A Crisis of Trust in Life SciencesTimely completion of clinical trials is the weak link in the drug development process, and there is no shortage of suggestions for how to improve it.
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Major Changes to Clinical Trials Regulation in the EUThe new Clinical Trials Regulation introduces an overhaul of the existing regulation of clinical trials for medicinal products in the EU.
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Switzerland Guides Innovation in Clinical Trial RegulationsThe country’s introduction of a new legal framework has it in sync with European law on clinical research.
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Strategic Approach Needed for International Clinical TrialsLonger-term strategic issues are making already high-investment, high-risk decisions to place studies overseas even more complex.
