5 things to know about clinical trials

On Day 1 of the BIO CEO and Investor Conference, a panel—Prioritizing CRO Spending Through a High-Inflation, Sparse-Funding Period—brought together experts to look at how companies can utilize CROs, or contract research organizations. But panelists went far beyond CROs to talk about key issues for clinical trials in 2023, including decentralized trials, the outlook for AI and digitization, and why clinical trial diversity matters.

Here are five things to know about clinical trials in 2023.

1. ‘It’s not an if but how to prioritize CROs.’

Even in a volatile economy, biopharmaceutical companies must continue R&D—after all, that’s the lifeline of many biotech companies, especially small and pre-clinical companies.

This is where CROs, or contract research organizations, can help.

In a nutshell, CROs support biopharmaceutical companies in developing, implementing, and completing their clinical trials. They can be especially useful in a volatile economy, by helping small or pre-clinical companies bring their product to market without needing to hire additional staff.

In 2023, “it’s not an if but how to prioritize CROs,” said panel moderator Arda Ural, Ph.D., Americas Industry Market Leader for Life Sciences and Healthcare for Ernst & Young.

2. Trials can be decentralized, but patients should remain at the center.

The COVID-19 pandemic brought about new ways of doing clinical trials. Specifically, the pandemic decentralized trials, because we had to “move and sustain trials with urgency,” said Craig Lipset, Advisor and Founder of Clinical Innovations Partners. Lipset is also Co-Chair of the Decentralized Trials and Research Alliance (DTRA).

But you still must engage with patients. For example, it’s not that patients don’t like going to clinical trial sites—on the contrary, the “overall satisfaction rating from sites is overwhelmingly positive,” he said. It’s just that patients sometimes have difficulty getting to the site.

The answer is not to do away with research sites but to “open more pathways for patients.”

It’s important to “have your patient at the center,” added Michelle Keefe, CEO of Syneos Health, a CRO based in North Carolina.

3. AI can aid trials when used correctly.

With the rise of ChatGPT, everyone’s talking about AI and automation and the role these tools will play in clinical trial design and implementation. New technology can help on the front end of clinical trials, such as determining feasibility, finding the right patients, and onboarding sites.

“You don’t need humans to onboard a site,” said Simon Burns, CEO & Co-Founder of Vial, a CRO with a mission to deliver “faster, more efficient trials.” What’s problematic, he said, is when you have “unstructured information” and processes like emails, regulatory document capture, and budgeting, which can make it difficult to digitize and automate.

“If you structure, you can digitize and get better data,” he said.

The key is to “marry AI and machine learning with human expertise,” said Keefe. Then, add a layer of behavioral science to understand “why patients do what they do.”

4. Relationships with regulators matter.

The COVID-19 pandemic accelerated the decentralization of clinical trials. However, it will be interesting to see how regulators approach trials and these changes in the future, said Lipset.

Your relationship with regulators is key, especially in your initial trial design, said Evan Loh, CEO of Paratek Pharmaceuticals, Inc., which is developing solutions for antimicrobial resistance.

“Don’t just listen to your board and make your trial sample size smaller,” he said. “You have to have a discussion with your regulators.”

Otherwise, you might compromise reporting, data integrity, and interpretation, and need to redo your trial.

5. Clinical trial diversity matters.

To capture good data, you must “make sure your patient population and the epidemiology match,” said Keefe. And as Bio.News reported, the omnibus bill passed at the end of last year passed laws mandating diversity in clinical trials. How will this change the industry?

We “have to have plans in place to show how we will enroll a diverse population,” said Lipset. However, we also need to think about “what will drive sustained commitment to representation in clinical trials.”

To improve diversity, we must communicate with patients, enable their participation, and understand what gets in the way of participation. “Patients are people, and life gets in the way—not their disease, not their desire [to participate], but their life,” said Keefe.

Digitalization can help by eliminating “geographical bias,” added Burns.

And don’t forget about age when it comes to diversity, said Loh.

Without diversity in our clinical trials, “we are creating a made-up world and projecting to the full population,” said Ural.