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Fresh Initiatives Revealed for Clinical Studies

by Imogen Cheese
Fresh ideas for clinical studies

The Outsourcing In Clinical Trials (OCT) Europe conference held in Barcelona was fully face-to-face. No prerecorded talks! A conference hall heavy with exhibitors for clinical studies. With hundreds of delegates walking around laughing and chatting, all enjoying the return to business as usual!

In-person conferences are back, and it’s fantastic!

Making strides from lessons learned

There was the inevitable nod to the pandemic. I’m not referring to people still wearing face masks and diligently using hand sanitizer at every corner of the exhibit hall. Several speakers talked about the impact of Covid on clinical trials. There was a panel discussion about the trials and tribulations of conducting clinical trials during the pandemic. One of the panelists, John Zibert from Leo Pharma, said,

Quite clearly, many people struggled generally with health care on all levels during the pandemic. Not just those involved in critical care or clinical trials.

Though the reality of the last two years is still fresh, once we get past the misery, anguish, and trauma caused by the pandemic, we see great strides. Our industry has made these strides as a direct result of Covid. The obvious first example is the speed at which clinical studies, especially Covid clinical trials, were approved, delivered, and regulated. Additionally:

  • the number of studies delivered last year
  • the huge leaps forward with trial design
  • bringing in hybrid trials
  • starting completely decentralized trials

… are significantly shaking up our industry!

New doors open for clinical studies

New doors open

Alastair MacDonald, senior vice president of Global Client Solutions at Syneos Health, shared a new partnership model that Syneos has been using with some of its clients. They call it Product Development Organisation, or PDO. This moves away from the standard CRO model. They believe PDO may be a smart pathway forward for many CROs looking to establish long-term collaborations with their clients.

PDO represents total integration and a shared risk approach between the CRO and sponsor. The PDO model has the potential to maximize trial success and deliver greater results. This includes an increase in the number of products that reach the market.

Since we were in Spain, where football (soccer) is very popular, MacDonald used the analogy of how many shoots to goal a sponsor might get with a drug. By operating at cost for Phase 1 and 2 studies, Syneos would give the sponsor the opportunity to increase the number of “shots” at the early stage. They would then benefit from partnering in a higher number of successful Phase 3 and 4 studies as a result. It might be seen as a risky approach by some, but as a model, I think it’s genius.

Far too many studies don’t get past the first stages. This isn’t because the drug isn’t right. It’s because clinical studies are expensive, and adjustments are often needed before finding the right balance. More opportunities to find the right balance in those early stages of a clinical trial would logically mean a greater chance of finding the right model and the right mix to make it to the next step!

Untapped global options 

Novotech’s David Chia presented another interesting talk. Novotech is an Asia-Pacific-based CRO that has seen a pattern over the last two years. U.S. and European sites may have paused during the pandemic for safety reasons, whilst many Australian sites continued to deliver clinical trials throughout. Numerous sponsors and CROs have rightly been looking toward the Asian-Pacific for the delivery of clinical trials.

Just as there had been at other conferences I attended this year, diversity was a hot topic for discussion. Chia suggested that diversity doesn’t need to be just about the cultural or ethical representation of the participants in a study. He called on us to think logistics, about where the study itself is located, and look at a more diverse range of startup options.

Chia shared statistics showing that starting up an early phase site is 25 to 40 percent cheaper in China than it is in Western countries. China has a larger patient pool and due to some innovative thinking by the Chinese government, the shorter timelines can have a beneficial impact.

Clearly, the world is a big place, but locations like Australia and Asia are not actually that far away and should be considered and included in any strategy for study startup. Leverage new markets globally. There are challenges of course when looking at global studies. However, when you work with the right vendors and have clear communication and an understanding of the steps involved, things that might seem risky at first can often be innovative and ingenious!

Lessons learned from Covid

Lessons learned from COVID

 

The OCT conference showed that whilst Covid slowed things down in some ways, our passion to deliver studies is as strong as ever. And more importantly, our industry seems to have learned a few marvelous lessons and is introducing some fabulous projects along the way.

Alina Pszcolkowska from Astrazeneca talked about a project that had my trial participant sensors buzzing with interest, and, frankly, excitement! Clinical studies are becoming longer, slower, and more expensive. Thus, her team has been working through ways in which operations, in particular, can gain insight and contribute to trial design at an earlier stage to minimize this impact.

Her team at AZ has been developing a Patient Burden Index. They have tested it fully on two specific and very different studies. They looked at:

  1. The burden of the indication and of the study.
  2. The consequences to the patient of that burden. And is the study itself exacerbating that burden?
  3. How can we (AZ) reduce that burden?
  4. Better trial design and delivery/support.

They have published early results from the first study and should have the full results across both studies in a few months. When they do publish, I would urge you to look at this approach. From a trial participant perspective, I find it very clever!

Patient-centric success

Clinical trial initiatives that are designed for the patient first – before the study begins — make me happy. Estrella Garcia (Almirall) and Luke Gill (TFS HealthScience) shared the success of a recent partnership where they actually increased patient recruitment and retention on a study by over 30 percent.

They created an app to work alongside other study delivery initiatives and served multiple purposes. The app looked creative and user-friendly, and it simultaneously helped the trial participants and the study sites as a tool for the collection and delivery of the data captured during the duration of the study. The app offered advice to the participants about their indication, plus guidance and support.

Clinical trials are changing

My OCT take-home thoughts? It’s truly possible: we can be partners, with clinical trial participants and with our industry colleagues. We can work in ways that are new, and ways that are challenging that might seem risky. And we can achieve real innovation and deliver trials that are considerate of the constantly evolving and ever-increasing burdens faced by participants and sites every day.

 

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