Featured Editorial

  1. Safety-centric Monitoring: Measuring Safety Data In A Consistent And Standardized Manner 6/19/2023

    Today, we have access to more data than ever before, and in an ever-advancing technological landscape, it is increasingly important to adopt a safety-centric monitoring approach that ensures we can measure safety data in real time and in a standardized manner across the industry. The challenge now is how to extract and leverage the quality data from the large volume that we have access to.

  2. Advancing Rare Disease Research With Patient Registries 6/16/2023

    In this Q&A, “Rare dad” Harsha Rajasimha, Ph.D. of IndoUSrare discusses the current state of rare disease research and explains how patient registries can help propel drug development for rare disease therapies. 

  3. How PROs Enhance Patient Care Decisions And Future Clinical Research 6/12/2023

    Patient-reported outcomes (PROs) offer unique insights that complement traditional treatment efficacy endpoints, such as survival or disease relapse, and can facilitate better discussions between clinicians and patients. When PROs are incorporated into clinical trial protocols, sponsors can gain a better understanding of the treatment’s impact from the patient’s perspective. 

  4. How Do You Determine If RWE Is A Good Fit For Your Org? Ask (And Answer) The Right Questions 6/5/2023

    Real world evidence (RWE) is being heralded as a way to enrich our clinical data and lower the barriers to reimbursement. It also carries the potential of reducing the patient burden and lowering the cost of clinical data acquisition. But before getting to the point where we can reap the promises of RWE, we face a number of challenges as an industry. 

  5. Clinical Trial Diversity, Flexibility Championed By The Food And Drug Omnibus Reform Act 5/23/2023

    The Food and Drug Omnibus Reform Act, signed into law by President Biden on Dec. 29, 2022, includes provisions intended to modernize clinical trials and are broadly divided into two categories: encouraging the enrollment of diverse populations and facilitating novel clinical trial designs.

  6. Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs) 5/18/2023

    When it comes to wading into the muddy waters of a DCT, it's important to specify the risks up front and determine how decentralization is appropriate for each protocol. From a data collection and management standpoint, there is plenty to consider in terms of data flow management through multiple sources and systems.

  7. FDA Releases Draft Guidance On Decentralized Clinical Trials 5/18/2023

    The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices. Check out the key takeaways related to remote trial visits, digital health technologies, and more. The public comment period ends August 1, 2023.

  8. Patient-Powered AI Is Driving Science And Innovation Forward 5/17/2023

    Drug discovery is a game of information: If we understand disease well, we know where to intervene and how to design a molecule to target the disease. AI can be used to integrate the patient experience and voice into solutions, further enhancing their relevance. 

  9. FDA's Digital Health Technologies Framework Addresses Important Challenges 5/16/2023

    In March 2023, CDER and CBER published a Framework for the Use of Digital Health Technologies (DHTs) in Drug and Biological Product Development (the “Framework”) to “guide the use of DHT-derived data in regulatory decision making for drugs and biological products.” Here is what you need to know.

  10. Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials 5/10/2023

    The benefits of real-world data (RWD) have been so promising, the FDA now recognizes RWD — and corresponding real-world evidence (RWE) — as valid tools for monitoring the safety of products post-market and, in some cases, for making regulatory approval decisions. At Freenome, we first integrated the use of RWD during a clinical study launched in 2022 for the early detection of multiple cancers. Along the way, we’ve discovered several benefits RWD can bring to any clinical research program.