GUEST COLUMNISTS

• FDA Releases Draft Guidance On Decentralized Clinical Trials

  The FDA has released a new draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices.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.

• Understanding Data Collection And Management In Decentralized Clinical Trials (DCTs)

  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.

• Patient-Powered AI Is Driving Science And Innovation Forward

  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. 

• FDA’s Digital Health Technologies Framework Addresses Important Challenges

  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.

• A Primer On ICH M13A: Bioequivalence for Immediate-Release Solid Oral Dosage Forms

  The International Council for Harmonisation (ICH)'s reflection paper on "Further Opportunities for Harmonisation of Standards for Generic Drugs," released back in 2018, is currently in public consultation stage and slated for adoption in November 2023. It provides recommendations on conducting bioequivalence studies during development and post-approval phases for immediate release solid oral dosage forms.

• Phase 1 Strategies To Optimize Orphan Drug Development

  While evidence of clinical activity is often sought and collected during Phase 1 trials, it is not typically the primary trial endpoint. But in later-stage trials such as a Phase 1b dose expansion study, there are opportunities to collect additional critical data that will help to guide further development. This includes clinical activity, biomarker and genetic mutation assessments, and preliminary impact in combination therapy. 

• Speed Up, Collect More, And Reach Further: Using RWD To Optimize Your Clinical Trials

  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.

• Advancing Innovative Therapies For Mild-To-Moderate Psoriasis With Novel PASI-HD Assessment

  The Psoriasis Area and Severity Index, or PASI, was developed in the 1970s as a tool for assessing the severity of psoriatic lesions for the purpose of assessing outcomes in a psoriasis clinical development program. But it falls short in assessing the severity of the disease in those wild mild to moderate psoriasis. Enter PASI-HD.