White Papers

41. Considerations For Clinical Studies In Migraine Prophylaxis And Treatment 8/28/2019

    Migraine is a neurological disorder that compromises quality of life and is disabling for a large, predominantly female population. Read more about the important considerations, risks and mitigations in migraine studies.

42. Considerations For Studies In Infectious Diseases Of The Genitourinary System 8/28/2019

    There is a substantial need for novel therapeutics for infectious diseases of the genitourinary system. Learn more about the requirements along with the key risks and corresponding mitigations in the studies of diseases of the genitourinary system.

43. Considerations For Clinical Studies In Heavy Menstrual Bleeding 8/28/2019

    Clinical trials of therapeutics for HMB involve unique operational and methodological considerations including defining eligibility requirements, proper training, and accurate measurements to name a few. Read more about these considerations as well as key risks and mitigations in HMB studies.

44. Capabilities For Clinical Studies In Contraception 8/28/2019

    Contraception studies involve a variety of unique operational and methodological considerations that may vary at different stages of development. This paper explains those considerations as well as key risks and mitigations in contraception studies.

45. Addressing The New Imperative To Include Females In Clinical Trials 8/27/2019

    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.

46. Ten Tips For Establishing the Clinical Utility Of Molecular Diagnostics 8/27/2019

    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.

47. Removing Barriers To Specialty Therapies 8/21/2019

    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.

48. What Clinical Teams Should Know About The Benefits Of Auto-Injectors 8/20/2019

    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.

49. Right-To-Try Or Right-to-Ask? Understanding Right-To-Try And FDA’s Expanded Access Programs 8/5/2019

    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.

50. Accelerating Regulatory Product Development And Approval For Drugs And Biologics In The U.S. 8/5/2019

    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.