The Rules Are Changing

The regulatory road in clinical research has had its fair share of bumps in recent years, to say the least. Just this calendar year alone has already seen drastic policy changes with diversity, equity, and inclusion (DEI) initiatives, funding cuts, and trial design changes. Sprinkle this onto the evolving world of technology, and there are a lot of moving parts within the regulatory landscape. Despite these hurdles, the industry is finding ways to persist. New workflows are now streamlining processes to ensure quality and safety in studies. Our June issue takes a look at how stakeholders are navigating the current regulatory landscape.

The first of our five feature articles this month focuses on embracing and deploying generative artificial intelligence (AI) at scale when conducting clinical trials. Clinical study reports (CSRs) are cornerstone documents in the drug development lifecycle. With the help of AI, their creation can be automated, saving critical time and resources. Featuring insight from leaders in Big Pharma, the article explores the key components in creating detailed and accurate CSRs with AI.

Staying on the topic of AI, following is a piece on how such tools can be harnessed by pharmacovigilance (PV) teams. It is no secret that data volume and design complexity have been increasing in clinical research. This is creating the need for PV teams to streamline operations. While AI has great potential in the area of drug safety, PV leaders must find a way to balance its benefits with the added responsibility of maintaining synergy between people and technology.

Our next June feature takes stock of advances in science and how the clinical research enterprise must catch up. The author details three opportunities for the industry to modernize clinical development—efforts where the leadership of regulatory bodies will be key. The next feature in our lineup again addresses the changing landscape of clinical development, but this time, the focus falls on risk management. With so many new advancements and workflows, sponsors can no longer take a linear approach to trial design, and instead must adapt.

Rounding out our five June features is an article on an important component of the EU’s new health technology assessment (HTA) regulation. The author details how sponsors can navigate the HTA policy update through the use of joint clinical assessments.

As always, thank you for reading.

Mike Hennessy Jr is chairman and CEO of MJH Life Sciences®