COVID-19 RESPONSE  Learn More

OCT East: Industry Agility and Decentralized Clinical Trials

by Dan McDonald
Decentralized clinical trials

Sponsors, CROs, and vendors gathered in person at the Outsourcing in Clinical Trials (OCT) East Coast Summit in King of Prussia, Pennsylvania, over two days in May. Speakers discussed the journey of recent years and shared predictions of what the future holds for new strategies. This included, of course, decentralized clinical trials.

The clinical trials industry is resilient. If you review the past five years, you’ll find:

  • Brexit, which quasi-remapped Europe for many companies with UK-based operations and caused a mad scramble to adapt.
  • Covid, and everything that came with it: shutdowns, innovation, hybrid approaches, and record-breaking vaccine development.
  • Increasingly complex and restrictive border controls as countries grappled with migration issues, growing nationalism, and the desire to keep the disease from crossing their borders.
  • War in Eastern Europe. It seems to have no end in sight and has as much chance of expanding as it does winding down.

As a result, our industry is navigating the new norm of uncertainty.

Covid sparks decentralized clinical trials

The Covid pandemic created an opening for innovators to step forward and fill the void during a time when traditional study conduct functions gave way to leading-edge digital and mobile functions.

Enter decentralized clinical trials (DCTs). New vendors got their chance to shine, and existing vendors pivoted to offer solutions. As we emerge from that challenging, exhilarating, and norm-busting time, sponsors and CROs alike are gingerly moving forward. All are working on blending the old with the new and meeting evolving regulatory requirements — all while adjusting to war in Eastern Europe.

Decentralized clinical studies are here to stay

We were given terrific insights in a presentation by Bonnie Bain, global head of pharma and executive vice president of healthcare operations and strategy at GlobalData Healthcare, a market intelligence company. Her company has researched the specific trends impacting drug development today and in recent years. She presented clear evidence of the continued and steady growth of DCTs.

Her data reveals artificial intelligence and big data are being most used by biopharmaceutical companies to bring DCT approaches to life and to help them understand when and where to use such an approach effectively.

Where should we focus?

When looking at the future, Bain’s research pointed to five areas that biopharma needs to focus on most:

1) Visualization: using graphics to change the way we see data and our work.

2) Connectivity: using networked devices to improve communication.

3) Collaboration: using technology to enable teamwork.

4) Interpretation: using artificial intelligence to improve decision-making.

5) Automation: using machines to complement human labor.

Sponsors need to use the technology and process innovation piloted during the pandemic to drive long-lasting efficiencies in the way we conduct trials.

We must analyze and adapt

OCT East Coast

 

Another session included two panelists from sponsor companies who addressed lessons learned and go-forward plans during these turbulent times. Cathleen Platt, VP of operations for Click Therapeutics, and Patrick Floody of Regeneron Pharmaceuticals gave the perspectives of small and mid-large sponsors, respectively.

Both said change will be constant. Being able to analyze trends and adapt quickly is critical to thriving in the current and near-future world. Cathleen stated that there’s “no going back at this point.” She said it’s “naïve to think it’s possible.” Companies are learning to “shift faster” using “technologies that are maturing and increasing in ease of use and capabilities.”

Patrick agreed. He said real-world data (RWD) is “helping companies adapt in real-time” and that RWD is helping companies “optimize their use of DCT.” As this session was positioned as a debate, it was interesting to hear their differing perspectives on vendor selection and relationships.

What might not be entirely surprising is that Click does not look for preferred vendors, because each of their studies is unique. Instead of engaging the same vendors each time, they “work with the vendors (they) need for a specific program’s needs, and customize the solution set accordingly.”

Whereas Regeneron works to qualify a core set of vendors that they can go deep within terms of a partnership, and a way of working together, they “spend time validating and qualifying vendors” for the longer term.

More than one approach is needed

OCT East Coast conference

Each company takes a slightly different approach to addressing uncertainty and evolving needs. I had a chance to ask them both a question during the Q&A session. Given the turbulent operating environment over the past five years, did they see companies retracting the geographic footprint of their trials? Both agreed that wouldn’t be the case. Instead, they are taking the learnings of those times. They are applying them to trial planning to be smarter about where they go. Additionally, they are putting together change management processes. These processes allow them to adapt faster to changing market dynamics. That can include war, a pandemic, or even murder hornets, as one attendee joked.

Decentralized clinical trials is the hottest term in the industry right now. But it is becoming increasingly clear that like many white knights we’ve seen before, it’s only going to be part of the solution. Smart companies and their partner CROs and vendors will:

  • Find a way to weave the old and the new to meet the needs of their studies.
  • Include contingency planning in their study planning process.
  • Build their businesses to be more flexible, using data and trend analysis to pivot when the next challenge arises.
  • Proceed forward cautiously but with the confidence of knowing they are prepared. They have risen to the occasion before and will do it again.

OCT East is a wrap, and the learning and lessons continue. See you at DIA in Chicago!

You may also like

Leave a Comment