Reduce The Cost Of Trials With Effective Innovation And Patient Engagement

By Ed Miseta, Chief Editor, Clinical Leader

Bringing down the cost of developing a new drug is a challenge to everyone in the life sciences industry. With clinical trials being a huge part of that cost, the challenge is taken seriously by everyone involved in the trial process. Taking a close look at the disruptions that can impact the clinical space would be a good start to determining where sponsors and CROs can be more efficient. 

This Q&A article is the second part of my interview with Stephen Cutler, COO of ICON. In this piece, Cutler discusses adaptive trials, patient recruitment and engagement, and the fostering of innovation within companies. He believes all three can have an impact on trials and reducing the cost of getting medicines to market.     

Ed Miseta: Do you like the progress we seem to be making with adaptive trials?

Stephen Cutler:  Absolutely. In a pharma company, one of the most critical things you can do is choose the right compound to develop. Adaptive trials will give us the best option to do that. Typically our trials involve many fixed assumptions. We make assumptions on the dose, the patient numbers and the trial designs. Then we drive the trial hard, and two or three years later take a look at the results. When you think about it, that approach actually seems a little crazy. We have the opportunity now to make some assumptions, and then check them along the way on a specified, pre-conceived basis. Changes or adaptations can then be made based on information coming in. It gives us a much better chance of getting the right answer in a timely manner.

Right now we are seeing increased interest in adaptive trials. Again, there is slow adoption, particularly in Phase 3, because of the conservative nature of our industry. There is a reluctance to jump into it and to some extent I understand that. But agencies such as the FDA and EMA have been very supportive of the use of adaptive techniques, and we are encouraged by that. More forward-thinking customers will engage with it, predominantly in the proof of concept, Phase 1b and Phase 2 space, and this will enable them to make better decisions about doses, patient numbers and, ultimately, about which drugs will move forward.

Miseta: Do you see progress being made in the area of patient recruitment?

Cutler:  Only three to five percent of patients participate in clinical trials, and that is a horribly low rate in what is actually a very beneficial area for trial efficiency. To change that I think you will see our industry getting much more involved with patients directly to promote the benefits of trials and encourage participation. Patient Advocacy Groups (PAGs) and registries of patients who have consented to be contacted will be an important part of this landscape going forward. It used to be that the sites did all of the recruitment. Now, I think you will see the PAGs out there being independent points of contact playing an ever increasing role of helping pharma build relationships with patients. Not only that, but patients can now get that information directly to their tablet or smart phone, enabling us to build better patient databases and to engage with them in ways we never could before. That is disruptive and it creates an entirely different dynamic. Having said that, there is no doubt that sites will continue to play a key role in the recruitment of and better engagement with patients in the trial process and helping to relieve the administrative burden is also an important part of increasing the participation of sites in trials.

Miseta:  I have heard people say we need to stop trying to figure out how to fit patients into a trial, and start figuring out how to fit trials into a patient’s life.  Will making trials more patient centric have a significant impact on reducing costs?

Cutler: I think we will see benefits if we take this approach.  If you design a trial that fits a patient it will bring benefits that increase retention and reduce costs. For instance, there could be a reduced burden on the patient to visit sites when you move to a more risk-based, as-needed approach, which I discussed earlier.  In some trials patients might have to spend a day at the site every few weeks. Reducing that burden is a win for patients and a real opportunity for pharma to improve patient retention.

I do believe we have moved away from the large-scale simple trial. I’m referring to studies with a large number of patients and inclusion criteria that you could fit on half a page. Some trials these days have inclusion criterion that are three pages long, leading to screen failure rates of 85 to 90 percent. It’s crazy. And then you take that drug and market it to the general patient population when the trial showed 10 percent of patients were eligible. When you think about it that way, you see how fitting patients to the trial can yield greater benefits. There may be some areas of greater risk and you will need more patients, but the data you get and the information you receive on these trials will be substantially more valid. There may be cost benefits, but I think the real benefits will be in what you are actually proving, and you will also have substantially more confidence in the validity of the conclusions made from the data. You should also have fewer safety issues down the line by having the right patients enrolled in the trial.

Miseta: Being disruptive can sometimes be discouraged. What can pharma and CROs do to better foster innovation within their own companies?

Cutler: I think there are a couple of ways to do it. At the end of the day, you need to have a company that positively encourages innovation. At ICON, we have a hackathon each year where employees can submit innovative ideas for the company to consider. It is followed up with an awards ceremony and prizes. We also have a Spark Innovation Hub, which is a system for ideas management that encourages our employees to share what can become a disruptive innovation.

We also have an innovation center, similar to what you might see in many large pharma companies, where we have technology experts who are focused on exploring the latest innovations and how these might change clinical trial dynamics and improve efficiencies. We tend to focus on areas that can make a real difference, such as patient recruitment and RBM. But the goal throughout is to challenge ourselves. To ask how something can be done as opposed to saying that it can’t be done. Only by constantly asking “Why not?” will we be able to move forward with truly disruptive ideas.     

We had some really good ideas that came out of last year’s contest. We selected what we felt were the top 10 and are now funding the best ones in a bid to operationalize them effectively.  New ideas require an investment of time and resources, but those are the ideas that will help our customers get medicines to market faster, better, and cheaper, which will ultimately help  patients.