Clinical Research: Phase 1 - Phase 4

PharmaLive | Advancing Gene Therapy Development: Key Regulatory and Clinical Trial Considerations

Insights into the human genome have created myriad therapeutic opportunities for previously untreatable diseases. Gene therapy offers promise for addressing unmet medical needs across therapeutic areas and even the potential for curing certain genetically based conditions. As research tools and technology become more sophisticated, gene therapy development is accelerating at an unprecedented pace. According to...

Pharmaceutical Outsourcing: Decentralized Clinical Trials

Patient centricity—also known as patient-centered care—has been a growing force across healthcare. Like the consumer-driven change in other industries, patient centricity upends established models. Whereas traditionally, healthcare professionals dictate care decisions with little consideration for the patient’s desires, patient-centric care puts the patient first. Its tenets include: • Empowering patients through technology • Reducing inconvenience...

FAQs: In Vitro Diagnostic Medical Device Regulation

On May 26, 2017, the EU Regulation 2017/746 of the European Parliament and the Council on in vitro diagnostic medical devices (IVDR) became active under the EU Regulation on Medical Devices (MDR). Recertification by May 26, 2022, became required for all previously approved products. The IVDR will replace the EU’s current Directive on in vitro...

Improving Birth Control for All: Opportunities and Obstacles in Male Contraception

Introduction There are currently more than a dozen categories of female birth control with proven efficacy on the market. For men, the only options available today are condoms and vasectomy. Despite decades of research and discussion about male contraception, no new products have entered the market since the condom was created in the 1800s. As...

Ten Tips for Establishing the Clinical Utility of Molecular Diagnostics: Stepping Stones to Precision Medicine

Introduction The strongest foundation for successful widespread marketing of any diagnostic is evidence of clinical utility. Clinical validation – determining a test’s ability to diagnose a health condition or predict risk of clinical outcomes – may fail to convince physicians and especially healthcare payers to accept a new diagnostic. Failure to gain payer acceptance may...

8 New Elements of the IVDR — and How to Change Your Approach

If you develop or manufacture in-vitro diagnostic products, you know the May 2022 roll-out date for the In Vitro Diagnostic Medical Devices Regulation (EU) 2017/746 (IVDR) is just around the corner. But what, exactly, does that mean? Many of our sponsors have been approaching us with questions, such as: What aspects of the IVDR apply...

Clinical Researcher: Preparing for the Future

In July 2021, the Industry Standard Research (ISR) Report on Hybrid/Virtual/Decentralized Clinical Trials Market Outlook surveyed 109 industry leaders worldwide who had been involved in DCTs over the past year.{1} Respondents anticipated a 12% increase in hybrid trials over the next two years—and predicted that DCTs would outstrip traditional trial models within three years. They...

Premier Insight 278: A Decade-Long Partnership Culminates in FDA Approval

Background Psychiatric conditions are complex, chronic, often debilitating diseases, and there remains a persistent need for novel medications with proven efficacy and safety. Many of the established antipsychotic agents are highly effective but are associated with significant side effects that may negatively impact adherence and patients’ experiences with treatment. Thus, recent research has focused on...

Digital Disruption in Dermatology: The Role of mHealth Technologies in Clinical Care and Clinical Research

In a fast-paced digital world, healthcare has had to adapt to better serve consumers who increasingly prefer the convenience of web- or app-based services to in-person assistance. Mobile health (or mHealth) solutions provide increased access to care, making it easier for patients to receive care and for healthcare professionals to deliver that care. Visual assessments...

Rare Disease Recruitment: 5 Strategies for Differentiating Trials in a Competitive Research Environment

Recruitment for rare disease research has always been difficult due to myriad factors inherent to the low incidence and prevalence of these conditions. In recent years, however, recruiting for rare disease trials has become even more challenging due to increasing competition in the clinical research environment. In addition, as technologies advance and information becomes more...