29 June 2020 – Cleo François MSc, Regulatory Affairs Manager The new European Clinical Trial Regulation (ECTR) will replace the 2001/20/EC Directive, the directive that currently describes how clinical trials should be conducted in Europe. The main objectives of the new ECTR are to make Europe attractive again for research and development (R&D) initiatives, to create an environment that is favourable for conducting clinical trials, and to encourage more sponsors to conduct trials across the European Union (EU) member states. The regulation will have a major i ..read more

By Ashley Henderson, PhD, CATO SMS Scientist 1.0 INTRODUCTION The COVID‑19 pandemic has added an unprecedented set of challenges to the conduct of clinical trials including quarantines, travel limitations, site closures, and interruptions in the supply chain of investigational products. In acknowledgement of these challenges, the Food and Drug Administration (FDA) recognizes that protocol modifications may be required and protocol deviations may be unavoidable. FDA initially issued  FDA Guidance on Conduct of Clinical Trials of Medical Products during COVID‑19 Public Health Emergency – Gu ..read more

In a recent Ask Cato blog post, I summarized a revised FDA guidance issued in January 2019, Rare Diseases: Common Issues in Drug Development.1 The guidance covers a range of topics, including the use of surrogate biomarkers, nonclinical flexibility, and natural history studies, to assist sponsors in conducting more efficient drug development programs for rare diseases. In March 2019, FDA released its sixth rare disease guidance, Rare Diseases: Natural History Studies for Drug Development,2 which expands on the topic of natural history studies and how they can be used to support the development ..read more

Why does everyone talk about “Patient Engagement” in clinical trials? By Shirley Greenfeld Senior Clinical Research Associate As trials are becoming longer and more expensive and many of them fail to meet their recruitment goal, patient engagement plays a key role in the success of a clinical trial. But what is exactly patient engagement and why is it so important? Getting to know the person behind the “subject” title Times have changed, and nowadays, more than ever before, patients are more involved in their own clinical care. Equipped with knowledge gained from a variety of available resou ..read more

Pharmacogenetics – Tailoring your product to fit the genes By Carron Sher, M.D. Senior Clinical Research Physician   John received anti-malarial therapy and developed severe hemolytic anemia.  He was diagnosed as having G6PD deficiency. Sally was started on warfarin and there was a problem in achieving the desired therapeutic response.  She was diagnosed as having the CYP2C9 *2 variant. In John’s case a genetic variant resulted in a potentially life-threatening adverse event while in Sally’s case a genetic variant resulted in requiring a lower dose of the drug. Just as one pair of jeans does n ..read more

By Hadas Jacoby Adani, Marketing Manager, Israel, Cato Research Technology is slowly but surely penetrating the healthcare industry in general and the clinical trials sector in particular. New and advanced solutions offer a variety of possibilities aimed to both improving existing processes and creating new and more efficient ones. And on top of all stands the desire to make clinical trials more patient-centric. In all of this, even though some of the technologies have yet to mature enough to meet the high quality standards necessary, it is important to know them and begin imagining the promis ..read more

By Denis Okumu, Ph.D., Postdoctoral Fellow at Cato Research Ltd Civil Money Penalties Relating to the ClinicalTrials.gov Data Bank Section 801 of the Food and Drug Administration Amendment Act of 2007 (FDAAA) amended section 402(j) of the Public Health Service (PHS) Act[1] to require that responsible parties and/or submitters of certain applications and submissions to FDA regarding drug products, biological products, and device products (hereafter, “submitters”) submit registration and/or results information to the ClinicalTrials.gov data bank and/or certain certifications to FDA for certain ..read more

By Nicola Main, Clinical Research Manager I, Clinical Trial Operations – Rest of World Cato Research   Medical Device Workshop at MCC – 13/14 July 2017 – Summary for SACRA Members This workshop provided supporting information and explanation of items contained in the various guidelines regarding medical devices. These guidelines are in the process of being finalized and are posted on the MCC website, either under the Publications / Guidelines tab; or under the Publications / Industry to Comment tab. Most of the discussions related to the licensing of the various local device suppliers, includi ..read more

By Joanne McNelis, Ph.D., Clinical Strategy Scientist at Cato Research FDA draft and final guidances, released from CDER, CBER, and CDRH in December 2016 are posted. In addition, upcoming advisory committee meetings are listed below with links to more information. Special Interest Guidances/Information Date Posted Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act. – Final Guidance 30 Dec 2016 Medical Device Accessories – Describing Accessories and Classification Pathway for New Accessory Types ..read more

By Amelie Rodrigue-Way, Ph.D., RAC (CAN), Associate Director, Regulatory Strategy for Cato Research Canada. As part of the Regulatory Transparency and Openness Framework (http://www.hc-sc.gc.ca/home-accueil/rto-tor/index-eng.php), Health Canada has committed to provide greater transparency and openness to further strengthen trust in their regulatory decisions. The Framework will: Help Canadians to better understand how and why decisions are made. Canadians will be able to use this information to make well-informed decisions on their health and the health of their families. Assist industry to b ..read more