Clinical Guest Contributors

  1. Real-World Evidence In Clinical Research: We’re Not In Kansas Anymore

    This is the first article in a two-part series addressing real-world evidence (RWE) for life sciences leaders who may be struggling to make sense of the rules.

  2. An Inside Look At Novo Nordisk’s Disease Experience Expert Panel (DEEP) Model

    Novo Nordisk recognized that if it wanted to develop innovative treatments for patients living with chronic diseases, it was essential to form meaningful partnerships in which patients’ expertise, knowledge, and experience are included and put into action. It was this radical shift in thinking that led to the creation of the Novo Nordisk Disease Experience Expert Panel (DEEP), a network of patient experts and advocates.

  3. How Takeda Is Expanding Its Real-World Data Through A Global Myeloma Trial

    There is more focus than ever before on tailoring treatment plans to the unique needs of patients. One way to ensure we as an industry are delivering the most value is by examining real-world data (RWD) throughout the drug development process.

  4. The Journey To Global eConsent Adoption: Where Do We Currently Stand?

    Technological innovation is ongoing and is impacting all aspects of clinical studies, from study start-up through close out. While the shift to digital technologies is pervasive, the informed consent process remains paper based in many clinical trials around the world. Given its inherent inefficiencies and the increasing complexity of clinical studies, the current approach can raise challenges with respect to quality, compliance, and participant understanding. Considering this, sponsors must find new ways to ensure that potential study participants are fully informed, despite the complicated information provided.

  5. Patient Group Advances Clinical Trials, Diverts Patients From Unregulated Therapies

    For a patient with a debilitating disease, such as pulmonary fibrosis (PF), moments of hope can be few and far between. Many of these patients search desperately for new therapies to improve their quality of life, or possibly cure their condition, sometimes outside of the approved treatments prescribed by their healthcare providers.

  6. What Are The Financial Barriers To Site Sustainability, Patient Experience, & Overall Trial Success?

    Since its founding in 2012, the Society for Clinical Research Sites (SCRS) has advocated for rapid and accurate site payments. With her extensive background in clinical research, SCRS founder Christine Pierre had an in-depth understanding of the complexities of the industry and the need for key stakeholders to prioritize timely and accurate site payments using intuitive systems.

  7. Novartis’ Entresto Failure Highlights Need For New HFpEF Trial Designs

    Heart failure with preserved ejection fraction (HFpEF) remains one of the greatest and most challenging unmet needs in cardiovascular (CV) medicine. In contrast to the significant advances being made in the treatment of heart failure with reduced ejection fraction (HFrEF), little has changed in the approach to treating HFpEF in decades. The lack of effective treatment options is not due to the lack of pipeline activity in this indication but rather due to the 100 percent failure rate of late-stage clinical trials. What is the recipe for designing HFpEF trials with the best chance of success? There are several important considerations.

  8. Using Social Listening In The Design Of A Diabetes Clinical Trial

    Social media has become increasingly important in the biopharma space as it not only allows emerging clinical-stage companies to efficiently increase their visibility online by posting interesting content, but it also provides a unique platform to engage with members of specific disease communities. Read how Diasome is learning about those issues that are most important to patients and healthcare providers by compiling this data and analyzing online conversations.

  9. How To Conduct Better GCP Audits (Even When You Feel Like An Impostor)

    How many of us drive to work every day? How many of us know the route so instinctively that we no longer think about where we have to go? It’s easy, right?

  10. How Many Internal ClinOps Resources Should You Have For Study Startup?

    If you are like most small biotech companies, your budget is small and your timelines are as tight as possible in order to get the data needed to support the next round of funding and take the next step in your clinical development program. The best insurance you can use to achieve that next step and end up with a high-quality study that will pass an audit or inspection is proper planning ahead. This article will focus on proper resourcing of a sponsor’s internal clinical operations (ClinOps) team to adequately support a clinical trial during study startup.