Innovations Are Ready To Disrupt The Clinical Trial Process

By Ed Miseta, Chief Editor, Clinical Leader

If we want to bring down the cost of medicines, we need to bring down the cost of clinical trials. If there is one statement that I have heard from more pharma execs than any other, it is that. But Big Pharma can also be reluctant to change, and business as usual will not bring about the changes needed to truly disrupt the process.

In the clinical arena, we know we need to better engage patients, improve recruitment and retention, adopt mobile health technologies, and begin implementing other time and cost saving technologies (ePRO, eTMF, RBM, and more) that have the potential to make the entire clinical process run more efficiently.

This Q&A article is the first of a two-part series where I interview Stephen Cutler, COO of ICON, on what he sees as the most disruptive trends in the market, and the effect they can have on the pharmaceutical industry.

Ed Miseta: The cost of clinical trials is very high and many feel that bringing it down is the key to reducing the overall cost of drug development. What do you feel needs to be done?

Stephen Cutler: Costs are expanding quite dramatically, due to many factors including trials becoming increasingly complex. I think we all realize that costs cannot keep rising the way they have been. I think innovation in trials will be key to stemming those costs.

The first thing we can do is make clinical trials more centered on patients than the site. That balance definitely needs to shift a bit.  We need to give patients more information about the availability and requirements about trials.  I think increased patient engagement is where real opportunity exists for trials to become faster, better and cheaper.

Risk-Based Monitoring is also a hot topic and it obviously offers some cost benefits to companies.  At least as important, if not more important than cost, is the quality aspect of risk-based monitoring. It’s the idea that the resources we apply to trials can be used much more effectively, and with more value-add than currently exists.  Until now we have used what I call the shotgun approach; we go out, we monitor sites and we hope to find something.  Risk-based monitoring is a much more targeted value-add approach that will give us real opportunities to not only drive costs down but also improve quality.

We are a conservative industry for many good reasons, patient safety being the most important. In an industry where organizations have been successful there can certainly be a reluctance to change. I think we have to learn to be more open to new ideas and use some of the new techniques being developed. Some sponsors and CROs have begun the adoption process, but we need to see a lot more improvement.

Finally, we need to take a much closer look at the collection of data at the point of care. Patients, through their devices, will be recording responses to their treatment. This is a huge opportunity for us to make gains by being more efficient. We can have real time access to the data, make sure the data is accurate, and ensure patient care and safety. Right now we might have patients making 10 to 12 visits to a clinical site, but I can see how that could change quite dramatically for many patients in the future. Sites now have the capability to monitor patients in the same way we monitor sites. If a patient is not doing well, they can make sure they come in and are properly monitored and assessed. If a patient is doing well based on the information coming in, they will not need to make a visit. It’s exciting to see the opportunities for increased site efficiency. Ultimately it will give us the opportunity to perform more trials. We have some great sites out there, but they have so much work to do in a clinical trial that they often get overburdened. Relieving them of some of that burden will be a great efficiency enhancement.

Miseta: Do you have concerns about using some of these new mobile devices to gather data?

Cutler: I think one of the main concerns will be what to do with all the data that’s collected. I believe the wearable device revolution will tempt us to collect more patient data. That is unlikely to simplify trials or reduce costs. There is so much information out there that we can use, we need to be smart in deciding what we collect and how we analyze and use it. We need to ask the right questions and focus on the right information. The technology is out there to enable us to collect many parameters on a continuous basis – the question is whether that will lead to better decisions on which drugs to develop and market.  In my view, it should.

Miseta: In some respects, is part of the problem that we are collecting too much data?

Cutler: That’s true and in some instances technology is almost our enemy. We are now capable of gathering much more data and it is human nature to try and get as much as you possibly can. We probably need to be a bit more disciplined in fully understanding what data we need versus what will take time and effort to collect but is not really needed. 

Regulatory agencies are also under the gun. There have been some issues they have faced in the past few years, and of course we can never be sure that a compound will be 100% safe when it hits the market.  So post-marketing surveillance is very important, and more large scale, simply designed trials using real world data should be part of the equation – particularly post launch.

Editor’s note: In part 2 of this article, Cutler discusses progress made with adaptive trials, fostering innovation in companies, and how more effective patient recruitment and retention can help to control the rising cost of trials.