CLINICAL TRIALS ARTICLES

• The Future of Clinical Research Is Bright

  This is an exciting time to be involved in clinical trials. I feel like I have been saying that for the more than eight years that I have been writing about clinical research, and every year seems to bring new technologies and new opportunities.

• Message To CROs: Keep That Pandemic Tool Belt Handy

  During the last year, despite countless obstacles and dangers, the pharma industry managed to remain steadfast and get to where we are today – hopefully with COVID-19 in the rear-view mirror. Let’s take a closer look at the numbers.

• Don’t Overlook The Risks Of Innovative Clinical Trials

  Advancements in AI and machine learning (ML) for data collection and interpretation could increase the threat of cyber-attacks and malicious hacking of private medical data. As such, sponsors shouldn’t overlook the liability risk of such advancements and the corresponding changes that should be made to business insurance.

• The 3-Step Approach To Unlock The Power of Historical Trial Data

  Many biopharmas still find it difficult to make sharing and using external trial data routine. How do we build on new momentum to continue and accelerate the use of historical trial data to transform R&D in the future?

• A Drug Developer’s First Experience With Decentralized Trials

  When the FDA released new guidance for companies in May, it seemed every drug developer was scrambling to convert their clinical trials to a decentralized approach. Advicenne was no exception.

• Digital Technologies Will Continue To Drive Patient Outcomes

  While other companies scrambled to implement clinical trial-related technology to deal with the pandemic, Otsuka was an early adopter of tools such as eCRF and eConsent.  Christoph Koenen, EVP and chief medical officer at Otsuka Pharmaceutical Companies (U.S.) explains how digital technologies will continue to drive patient outcomes.

• Achieving Diversity And Building Trust In Clinical Trials

  Acknowledging the current shortcomings of clinical trials and understanding the underlying causes are the first steps to achieving more equitable research design.

• The Hidden Real-World Reasons For Poor Clinical Trial Diversity

  To achieve better outcomes and health equity for historically underserved populations, we must address the not widely acknowledged, hidden, real-world reasons for such poor diversity in clinical trials.

• Clinical Data Trends: Transforming Data Access/Analysis

  Today’s clinical data ecosystem demands new strategies and standards. Here we present three pillars of an effective data strategy.

• Increasing Patient Diversity In Clinical Trials

  The COVID-19 pandemic has spotlighted healthcare’s biggest shortfalls. One of the most glaring problems sounds like it should be simple to resolve, but it has actually been challenging to implement — diversity in clinical trials.