White Papers

  1. Addressing The New Imperative To Include Females In Clinical Trials

    As a leader in women’s health research, Health Decisions has extensive experience in recruitment of female subjects for trials in a variety of indications, including but not limited to women-specific indications. Health Decisions is pleased to share some lessons from our experience in women’s health studies to assist sponsors in increasing female participation in studies across the therapeutic spectrum.

  2. Ten Tips For Establishing the Clinical Utility Of Molecular Diagnostics

    The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. What diagnostics developers may fail to consider in planning a trial to demonstrate clinical utility is the complex sequence of activities that are necessary to transform the result of their new test into an improved health outcome. The following tips for establishing clinical utility of molecular diagnostics studies address a variety of issues with particular attention to the requirements of conducting RCTs to provide evidence of changes in treatment decisions and health outcomes.

  3. Removing Barriers To Specialty Therapies

    Gaining access to specialty medications requires navigating multiple complex pathways, including determining insurance coverage options, co-pay amounts, the patient’s total cost of therapy, prior authorizations, and appeals. Obstacles along each path can lead to increased turnaround time and drive script abandonment. Technology brings advancements for removing these barriers, but buyer beware.

  4. What Clinical Teams Should Know About The Benefits Of Auto-Injectors

    For a host of reasons, auto-injectors are becoming biopharma companies’ delivery method of choice for commercial use and late-stage clinical trials. Auto-injectors ensure that the prescribed dose of medication is delivered fully and completely,making it easier to track compliance in clinical trials.

  5. Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access Programs

    Programs providing seriously ill patients with early access to investigational products are of great interest to the public, but what are the implications to pharmaceutical and biotechnology product companies? This article examines Right-to-Try legislation as well as FDA’s existing expanded access programs from the perspective of companies who are considering providing investigational products to patients with serious or life threatening diseases that have exhausted all other treatment options.

  6. Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S.

    The Food and Drug Administration (FDA) has created five mechanisms to presumably speed the approval of drugs and biologics that effectively treat serious diseases, especially those that are the first of their kind or those that provide increased benefit over existing treatments. Following is an overview on how to appropriately use these five programs to maximize speed of approval depending on the product type.

  7. Seven Essentials For Successful Drug Development

    In reflecting on the differences between successful and unsuccessful clinical trials or programs, several factors consistently emerge as essential components of success and failure. This article reminds of the essentials so that effective therapies have a greater likelihood of reaching patients in need.

  8. Reducing Late-Phase Trial Costs, Failures

    Identifying appropriate dose ranges for pivotal trials remains a major drug development challenge, particularly for new molecular entities (NMEs). Multiple Comparison Procedure – Modelling (MCP-Mod) is a powerful statistical tool that greatly improves the design and analysis of dose finding studies for more accuracy on the targeted dose range. Combined with the adaptive study design, simulation and modelling capabilities of ICON’s ADDPLAN® neo, adaptive MCP-Mod may significantly enhance drug development efficiency.

  9. Patient Centric Monitoring Methodology

    There is a shift in the pharmaceutical and CRO industries to improve the efficiency, effectiveness and quality of clinical trial research and the data generated together with improving patient safety. Read how Patient Centric Monitoring enables faster data access and quality checks, enabling early detection of errors and risks and ensuring improved patient safety plus data quality and integrity.

  10. Improving Regulatory And Operational Performance In Orphan Drug Development

    The marketplace for orphan drugs is growing, and changes in the regulatory landscape are providing favorable conditions for collaboration in the area of drug development in rare diseases. Understanding the regulatory and operational nuances of orphan drug development can help sponsors position their promising compounds for clinical and commercial success.