A key element of the 2007 FDA Amendments Act (FDAA)—the change from "requested" post-marketing compliance plans to mandated Risk Evaluation and Mitigation Strategies (REMS)—has now come to the forefront for both newly approved and commercial biopharmaceuticals. While some REMS are little more than a beefed-up patient medication guide, others can involve complicated patient registries and certifications of physicians, pharmacists and even distributors.

According to The Experience of Frequent Heartburn in America, 2009(2), a study of 1,075 frequent heartburn sufferers conducted by Center for Health Outcomes Research & Evidence Based Medicine, LLC and United BioSource Corporation, frequent heartburn can significantly impact sufferers' lives by affecting their ability to get a good night's sleep, be productive at work, have positive personal relationships and enjoy social activities.

Understanding the nuances of setting up an effective global registry is becoming increasingly important, since this kind of study enables manufacturers to gather and analyse data about the actual use of their products in every country where a product is marketed, while meeting stringent new regulatory requirements.

Postapproval studies are typically initiated to gather additional product safety information, comply with a postmarketing requirement (PMR), or support overall market access. Many times, these studies require enrolling very large numbers of patients at often research-naïve investigative sites to address pressing study objectives. Many sponsors and CROs erroneously believe that a phase III operational approach will meet all needs of a postapproval study. However, applying phase III processes can result in study delays, astronomical budgets, and dissatisfied study investigators. Streamlining all aspects of postapproval studies is key to overall success.

Once considered a rarity, the "rescue" or transition study is becoming more commonplace in today's fast-paced world of clinical trials. For a variety of reasons, more and more sponsors are finding the need to switch vendors mid-study. Examples include vendor inability to meet sponsor requirements, issues with the data capture system, and vendor collapse or acquisition.Once considered a rarity, the "rescue" or transi- tion study is becoming more commonplace in today's fast-paced world of clinical trials. For a variety of reasons, more and more sponsors are finding the need to switch vendors mid- study. Examples include vendor inability to meet sponsor requirements, issues with the data capture system, and vendor collapse or acquisition.

For more information on this topic or the actual report, please contact analytics@unitedbiosource.com or +1 301 654 9729.

While advances in medical science have led to continued improvements in medical care and health outcomes, evidence of the comparative effectiveness of alternative management options remains inadequate for informed medical care and health policy decision making. The result is frequently suboptimal and inefficient care as well as unsustainable costs. To enhance or at least maintain quality of care as health reform and cost containment occurs, better evidence of comparative clinical and cost-effectiveness is required

Obtaining optimal product positioning and market uptake requires thoughtful planning and a fresh perspective in this turbulent global economy. While the need for product differentiation and comparative assessment has been a constant, there are increasing pressures from formulary decision makers and payers demanding evidence backed by an increasing level of scientific rigor. The economic environment is acting as a catalyst in the movement, truly signaling that it is time to provide value-based evidence data to support formulary positioning and product access.

In both Europe and the US, a heightened focus on drug safety and risk management has led to new regulations that will result in significant changes for the pharmaceutical industry, particularly during the post-approval phase of drug development. Regulators at both the European Medicines Agency (EMEA) and the Food and Drug Administration (FDA) have embarked on new initiatives to update and expand methodologies used to monitor product safety after approval.

While Electronic Data Capture (EDC) has been considered a technology of choice to run Phase II–III studies, the industry is now finding that EDC can be particularly effective for late-phase programs, improving the speed and even the quality of real-world postmarketing research.

Rater reliability is the cornerstone of data accuracy for drug trials that depend on clinician-rated subjective instruments to assess efficacy. Every pharmaceutical company seeks unambiguous evidence that its product is the new best treatment for a given disorder. Increasing governmental scrutiny of new drug applications combined with rising costs of product development and rising industry competition are pushing companies to improve the margin of success for their clinical trials.

Given their focus on discovering and rapidly building scientific evidence to support the safety and efficacy of their compounds, emerging pharma companies often direct their limited resources to near-term activities. In doing so, they are often unaware of or undervalue the importance of getting early regulatory guidance on long-range development strategies.

The world of pharmacovigilance is changing quickly and dramatically in response to a set of new guidelines and regulations developed over the past four years. The goal of these documents is to aid industry in planning risk management activities throughout the drug development life cycle. Specifically, they define three types of activities: (1) pre-license efforts required to evaluate the safety of a product, (2) pharmacovigilance actions to be implemented in the early postmarketing period to monitor the products’ safety profile, and (3) steps to minimize risk. As such, these guidelines and regulations describe a method for summarizing important safety issues and propose a structure for a risk management plan.

Adaptive design, sometimes referred to as flexible design, is more than another new statistical methodology, tool or formula in the hands of biostatisticians. It’s a new technology that changes the entire clinical research process.

Since its founding in 2003, United BioSource Corporation (UBC) has focused on building a company that can harness the power of science and technology in new ways. As part of this strategy, the company announced two significant acquisitions in September 2007. First, it acquired an ownership interest in ClinResearch GmbH, a Cologne-based company specializing in adaptive design. Its second acquisition was Caro Research, a Massachusetts-based company focused on applying simulation techniques to understand the economic impact of drugs and devices.

Clinical trials frequently rely on subjective clinician-rated outcomes as pivotal endpoints. The scoring of these assessments is often based on clinical subjectivity and individual interpretation, which can increase variability across sites and raters – potentially contributing to failed or inconclusive studies.

In the ever-changing world of clinical trial management, there is a noticeably constant flow of new technologies and strategies. These new options offer organizations the chance to obtain better and more accurate information faster, leading to quicker clinical development of a drug. Two such emerging strategies are the use of adaptive design and the implementation of simulation modeling in clinical trials.

The fastest-growing area in outsourcing these days is late-stage clinical research. That's no surprise, since late-stage studies are the fastest growing part of clinical research. In 2006, CenterWatch estimated that the development spend for Phases IIB and IV would go from $9.2 billion in 2005 to $15.4 billion in 2009 - a jump of more than 60 percent. With the dramatic rise in late-stage studies, there is increasing emphasis on strategic planning to determine how sponsors should spend their budgets within the preapproval space.