Authors
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Personal Digital Assistance: Finding the Right PDA for the JobThree profiled companies have three different needs when it comes to choosing PDA.
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What Do We Know About Clinical Trials?I've recently reviewed many articles on subject recruitment, retention, and attrition in clinical trials. I have found the same three basic research methods: surveys (by telephone and in person), interviews, and focus groups. The information gathered from the three methods include demographics, willingness to participate, problems experienced in clinical trials, motivations for volunteering, health behaviors, social support, benefit expectations, and understanding of the research project. But such strategies collect only the most superficial data, so we don't know nearly as much about the clinical trial experience as we need to know.
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Clinical Research in Mexico: An OverviewThe United States and Europe host most clinical trials?and receive the benefits of drugs even when such trials are carried out in developing countries. Eager to correct an imbalance, Mexico wants to participate more extensively. Is it ready?
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Adaptive Patient Recruitment for 21st Century Clinical ResearchA key function in clinical trials, patient enrollment, has fallen behind during a time where technology has played a vital role in the industry. Adaptive patient recruitment allows for clinical data to be collected and reviewed in real-time as to improve enrollment outcomes as they are taking place.
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Good Site and Sponsor Relationships Pay OffBoth parties benefit from intentional friendships, and nowadays CRAs are key to this cordial effort.
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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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Some Things Work Better as PartnershipsPartnership agreements for CROs and eClinical technology providers can be as beneficial as sponsor/CRO partnerships.
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Progress and Potential: Evolution of the CRO IndustryThe CRO industry is on a course for continued rapid growth with the rise of genetics and genomics, as well as the push toward partnering and more postapproval research.
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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).
