Clinical Guest Contributors

  1. The Patient Perspective On Patient Centricity: Insights From A Veteran Of 5 Clinical Trials

    Those who know me understand the value I put on bringing the voice of the patient and caregiver into the drug development process. They also know that I believe that today’s terminology — phrases like “patient-centricity,” “patient at the center,” and other sexy mottos — is sometimes used by organizations to show the world that the patient is at the forefront of everything they do. But are they really? Is patient feedback on a protocol enough to prove that their voices are heard? Is providing input on an informed consent what a patient really wants to do? Maybe.

  2. What Will Clinical Trials Look Like In 10 Years? Experts Forecast 3 Key Trends

    Clinical research has benefited from several advancements in recent decades. Expanding access to information has empowered patients to have greater autonomy in their care and a voice during the development process. Personalized medicine has given rise to promising new therapies treating smaller, more targeted populations. And the number of clinical trials leveraging virtual health tools and mobile technology is increasing. But seismic challenges still remain.

  3. 8 Steps To Achieve The Cultural Change Needed For Co-Creation With Patients

    Now more than ever, patients are informed and active about their health. Technological advances are equipping patients with real-time health data. At-home genetic testing kits have the potential to reveal future health risks. And the internet can help increase health literacy and connect patients with other patients. These, and other tools, can empower patients to take control of their health while enhancing their ability to engage with the healthcare ecosystem.

  4. RWE In Clinical Research: Challenges, Opportunities, And 2 Case Studies To Move Us Forward

    This is the second 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. In this part, we will explore the challenges and opportunities RWE presents for life sciences companies, review two recent examples, and discuss how this newer way of thinking will transform the way we design and conduct clinical research or evaluate value-based decisions for the better.

  5. Tackling Pharmacovigilance Issues In The Clinical Trial Stage Of Product Development

    Pharmaceutical and device manufacturing companies often outsource their pharmacovigilance (PV) activities to vendors and consultants to meet their safety, medical information, and regulatory needs. When doing so, these companies have a regulatory obligation to oversee the activities and quality of their vendors. However, vendor audits conducted by these companies can yield a wide range of results due to differences in auditors, scope, and understanding of PV principles and operations.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.