From The Editor | October 18, 2019

Innovation Will Overcome Time & Cost Challenges Of Clinical Trials


The 2019 CNS Summit will kick off on October 31, 2019 and feature four days of sessions that are enlightening and inspiring, as well as unparalleled networking opportunities. This is the 10th anniversary of the Summit, which brings together thought leaders and innovators from sponsor companies, government, and solutions providers to collaborate and drive the success of future clinical development programs. With spotlight sessions focusing on artificial intelligence, digital therapeutics, real-world evidence, decentralized trials, putting the patient first, and more, this promises to be an event you don’t want to miss. 

One of this year’s presenters is Rob Scott, M.D., Chief Medical Officer and VP of Development for AbbVie. In this Q&A, Scott discusses clinical innovation, patient voice, and the clinical challenges the pharmaceutical industry still needs to overcome.

Ed Miseta: What topics will you be addressing in your session at CNS Summit?

Rob Scott
Rob Scott: Clinical Development and the conduct of clinical trials is entering a period of historic innovation. The combination of widespread internet connectedness and almost limitless cloud-based storage and compute capacity is creating opportunities to innovate around almost every aspect of clinical research.

As the process of clinical development has been getting ever more demanding and expensive, these opportunities are coming at a very opportune time. I will share practical real-life examples of how we are using big data and digital technologies to replace clinical trials, design better clinical trials, improve recruitment, help patients navigate their own trial experience and to collect better and more accurate data. I’ll share key learnings we’ve uncovered from the outcomes of our clinical trials and how we are using the Development Design Center now to spearhead these learnings to shape clinical trials in the future.

Miseta: What are the biggest clinical challenges facing the industry going forward?

Scott: With the cost of developing a new drug now over $2 billion, many good therapies that could improve patient lives will be left on the shelf. We have seen investment dollars fleeing areas like cardiovascular drug development, once the largest and now the smallest, particularly for highly prevalent chronic diseases. This is at the same time that cardiovascular disease remains the largest cause of premature mortality in both the developed and developing world. We need to find a way to develop drugs more cost efficiently.

Another challenge is that development programs are taking longer as Regulators raise the bar on the amount of data required to approve a drug. One of the biggest elements in the timeline is patient recruitment. Enrollment is becoming ever more competitive and patients per site per month have fallen to historically low rates. The industry has had to respond by increasing the number of sites per trial, hugely increasing cost and complexity. Part of the problem is that only 2 percent of patients participate in clinical trials even though 70 percent would like to. The biggest barrier to participation in a specific study is the distance to a study site. Technology is bringing the promise for any patient, anywhere, to be able to participate remotely and access to a much-expanded patient pool will allow quicker enrollment and simplified study conduct.

Miseta: Is the industry making any progress in getting the patient voice more involved in trial design?

Scott: As internet access is facilitating access to information about clinical trial participation, patients are becoming increasingly more sophisticated in how they show up. Smart clinical trialists are also aware that patient friendly studies are investigator friendly, which increases the ability to compete for available subjects.

Patient centric is becoming an industry buzzword. Unfortunately, Pharma companies still have attitudes around being the sponsor, even when it is “sponsor of choice”, that get in the way of having a true customer service culture. There is a strong sense of “tried and true” and “don’t fix it if it ain’t broke” that particularly gets in the way for relatively standard development pathways of the kind of innovation that can come from listening to the patient voice.

That being said, patient input during design and conduct of clinical trials is becoming more commonplace and is routinely a part of the Abbvie Development Design Center process. We’re also using apps and social media to facilitate patient involvement in clinical trials. The goal is to provide an immersive clinical trial experience incorporating a variety of digital health techniques that improve clinical trial outcomes and can also be incorporated into the product after launch to improve patient outcomes. We call these “tech-enabled” medicines at Abbvie.

Miseta: In terms of health care and drug development, what do you predict to be the biggest changes in 10 years-time compared to now?

Scott: While we are constantly continuing to improve our clinical trials and increase the quality of data collected, we are just scratching the surface of how technology can positively impact the process. In ten years, most data will be collected passively using IoT enabled devices and the EMR will become accessible to clinical trials reducing the burden on sites for collection and Pharma for monitoring. Machine learning and AI will help us use the rapidly growing data sources to design better trials, reduce drop out and non-compliance and better analyze results. The cost and the risk of clinical development will go down which will enable the development of precision therapies that are personalized towards smaller groups of patients.

The 10th Anniversary CNS Summit will be held in Boca Raton, FL from October 31st to November 3rd. For more information on the CNS Summit: PH (858) 324-1823, email, web