GUEST COLUMNISTS

• Can Anti-TNF Treat Post-operative Cognitive Decline? New Clinical Research Investigates

  People who suffer from post-operative cognitive decline can develop difficulty remembering things and performing daily tasks, and may possibly end up in nursing homes. There are no existing therapies. However, 180 Life Sciences believes it has a novel understanding of how to treat it.

• Harnessing The Human Virome For The Next Generation Of Gene Therapy Vectors

  Advances in metagenomic sequencing have revealed insights into the human virome with boundless value for gene therapy researchers. This includes exploring the diversity of a family of small commensal viruses called anelloviruses that have never been associated with disease. Anelloviruses are a promising new tool in our effort to overcome today’s limitations in genetic medicine.

• Collaborating With The FDA For Rare Disease Clinical Trial Success: Our Experiences

  If you are familiar with rare diseases, you know there are unique challenges associated with conducting clinical trials to evaluate potential new treatments for small patient populations. When we set out to design our Phase 2b study for a treatment targeting congenital ichthyosis, we knew we would need a plan to tackle these challenges. Here's how we worked with the FDA throughout the process.

• Realizing the Promise of Data Sharing: A Multi-Stakeholder Collaboration

  Sharing patient data generated from clinical trials has the power to transform the trial process itself, improving the patient experience and delivering life-saving and life-changing therapies faster and at less cost to society. This article shares the goals and efforts of the Clinical Research Data Sharing Alliance. And you can get involved!

• Clinical Outcome Assessment Testing: Which Rater Training Method Is Most Effective?

  For trials that utilize clinical outcome assessments as their study endpoints, rater training is paramount in ensuring data integrity by improving inter-rater reliability. The consequences of inadequate rater training can result in increased measurement error and data variance, significant increases in study costs, and incorrectly failed trials. Which rater training method is most effective?

• 6 Key Principles To Guide The Compatible Reuse Of Clinical Data

  As an industry, we have an obligation to maximize the value and utility of clinical data. Great value for both patients and sponsors can be derived from the reuse of existing data sets, which is why clinical data reuse is an area of increasing interest across the pharmaceutical industry. However, data privacy or data protection laws and regulations still apply.

• Gilead Sciences’ Innovative Approach To An HIV Clinical Trial

  When Gilead launched its Phase 3 study of investigational lenacapavir for PrEP, the team recognized that any clinical pathways intent on introducing new PrEP options must commit to addressing and effectively bridging existing gaps if we strive to drive real change in HIV prevention. This is the story of how Gilead approached trial design in an innovative manner.

• Best Practices For EDMS Implementation For Virtual & Early-Stage Pharmaceuticals

  Since the beginning of the pandemic, the clinical trials industry has rapidly adopted electronic documentation management systems (EDMS). However, for virtual and early-stage pharmaceuticals, an EDMS can pose several challenges. This article highlights the key factors that you should consider when evaluating the adoption of an EDMS to avoid the most common pitfalls.