Biostatistics Featured Articles

41. Will IBM's Watson Identify Patients For Your Next Trial? 9/15/2015

    Will ICON and IBM succeed in revolutionizing clinical trial recruitment and start-up times? Both companies certainly hope so, and look forward to combining assets to make the vision a reality. The cost and time invested by pharma companies in clinical trials is considerable. Each year more than $1.2 billion is spent on patient recruitment alone. Still, fewer than five percent of cancer patients will participate in a clinical trial. Adding to that headache for sponsors is the time involved. Starting up a global Phase 3 drug trial can take six to twelve months, with another twelve months necessary to enroll the required number of patients. This is a struggle most sponsors know all too well.

42. How To Achieve Success In An FSP Relationship 9/14/2015

    Deciding to transfer responsibilities from one vendor to another in the middle of a study is something every clinical professional dreads. Laurie Callen, Director of Clinical Data Management at TESARO, an oncology-focused biopharmaceutical company, knows the feeling well. She recently had to do just that when her company sought to restructure its outsourcing model in clinical data management by entering into an FSP vendor alliance.

43. 6 Ways To Increase Patient Enrollment In The Digital Age 9/8/2015

    If you are working on clinical trials, there is a good chance you are struggling with patient recruitment. While many new technologies entering the market have grandiose promises of increasing both recruitment and retention, few actually seem to be in operation and contributing to your patient totals. In fact, if you’re like most patient recruitment professionals, the words you likely utter most often are challenging, time-consuming, and expensive. Like it or not, those are the words that most often come to mind when contemplating the patient recruitment process for clinical trials. Of course, the problem is not confined to trials. According to Dian Griesel, Ph.D., CEO and president of Dian Griesel International, the challenge of recruiting patients is felt across the entire life sciences industry.

44. Is ClinicalTrials.gov Impacting Study Results? 9/1/2015

    Could forcing companies to report their trial methods and outcome measures prior to conducting a study actually impact trial results? According to a study conducted by PLoS ONE, the launch of the government website does seem to have had an impact on trial results. In a sample of 55 trials testing treatments for heart disease, 57 percent of the studies conducted prior to 2000 reported positive results from the treatments. In studies that were conducted after 2000, the studies reporting a positive result fell to only 8 percent. The difference is shocking, and naturally led to many questioning the possible role of the website.

45. Is The Sunshine Act Reducing Clinical Research Spending? 8/24/2015

    The intentions behind the passing of the Physicians Payment Sunshine Act were good. The Act required manufacturers of covered drugs, devices, biological products, and medical supplies to annually report to the Centers for Medicare & Medicaid Services (CMS) information regarding payments, ownership, investment interests, and other transfers of value to physicians and teaching hospitals. The intent was to reveal any conflicts of interest that might exist, with the end goal of hopefully bringing down healthcare costs. But even the most well-intentioned acts can have unforeseeable negative results. And it now seems the well-intentioned Sunshine Act may be having the unintended consequence of cutting down on the amount of investment making its way into clinical trials.

46. The Ethical Dilemma Of Patient-Funded Trials 8/17/2015

    Clinical trials are the costliest aspect of drug development. They can also be the most time consuming component of the discovery process. In those instances where the treatment is for a rare disease, patient funding could pick up the tab for research that pharma companies and governments are not willing to support. However, many would argue that pharma companies perform a lot of research and scientific rigor when determining which molecules are worthy of entering the clinical trial process. In a patient-funded model, desperate patients, and the size of their bank account, could be making those decisions.

47. Clinical Insights: Progress Being Made With Mobile Technologies 8/14/2015

    In this second part of my interview with Zaher El-Assi, president of Merge Healthcare’s eClinical division, he discusses the status of mobile technologies and wearable devices in clinical studies and the promise they hold for transforming trials via their application to Big Data.

48. Lessons Learned From A Venture Into Risk-Based Monitoring 8/12/2015

    Last year Trevena decided to undertake its first study incorporating risk-based monitoring (RBM). According to Ruth Ann Subach, director of clinical operations for Trevena, the approach was sexy and trendy and seemed to be what everyone was talking about. But having never done it before, she had a lot to learn. In this article, Subach takes you through the CRO selection process, documents she used throughout the trial, the decision-making process, lessons learned from the study, and the cost savings experienced by her company. Would she do it again? “Absolutely,” says Subach.

49. Clinical Insights: Market Growth Projected In China and South Africa 8/10/2015

    Zaher El-Assi is always looking for new opportunities. The president of Merge Healthcare’s eClinical division believes China and South Africa are two interesting locations for the conduct of global trials. In this Q&A article he shares his insights on both markets, why pharma companies need to be there, and the challenges companies can expect to face.

50. New EU Regulation Set To Drive Clinical Trial Harmonization 7/28/2015

    Sponsor companies conducting clinical trials in the European Union (EU) are currently regulated by EU Directive 2001/20/EC, which provides guidance on clinical trial applications and conduct. Unfortunately, Directives always have to be transposed into National law. By transposing, different countries interpret Directives in slightly different ways. Every country has its own national legislation, resulting in different submission requirements, timelines, classifications, and safety reporting. The result of this lack of harmonization is a complicated and expensive trial process.