Bringing the Quality and Compliance Perspective to Clinical Trials; a Look at the Industry with Patty Leuchten

Posted in Process Improvement

The following is an excerpt from Longboat’s downloadable interview series “Expert Opinions: How the Clinical Trial Industry Needs to Evolve” featuring full interviews with high-impact leaders from the clinical research world. To access the full interview series, click here.

Meet the Interviewee: Patty Leuchten, Founder and CEO, The Avoca GroupPLeuchten-199x240

Patty Leuchten started in the industry working at a large pharmaceutical company in clinical research then spent most of her career working at a number of the large CROs. After spotting an opportunity to drive change in the clinical trials industry she founded The Avoca Group, a consulting firm dedicated to improving quality and compliance in the clinical trial execution process. The Avoca Group celebrates its 20-year anniversary in 2019.

What was the opportunity you saw that inspired The Avoca Group?

I had ideas about how to bring sponsors and their clinical service providers into greater alignment and was interested in addressing how we might drive higher quality in clinical trial execution and, in particular, improve the quality of outsourced trials. That impetus hasn’t changed. We’re looking ahead to see where the industry is going and we’re in a good position to provide innovative solutions.

We’ve been tracking the progression of clinical outsourcing now for many years and there has been an evolution in the way companies are working together. There’s more structure around partnerships and relationships, and a higher level of professionalism compared with when I started in the industry. But we still see some of the same challenges that we’ve been observing for many years. We have a lot of industry insiders working with us, but by being outside of the industry we can act as an external catalyst to drive change.

What would you say are the biggest challenges or gaps between sponsor and CRO?

Some of the fundamentals are not being handled well. For example, sponsors taking responsibility for ensuring clarity around expectations and communicating those expectations is not being done consistently and with a strength in documentation. This is basic, but when there are disconnects around expectations, it causes so many problems downstream. Another issue is lack of clarity around roles and responsibilities. This often leads to inefficiency and duplication of efforts. Changing regulations create another layer of challenge. There’s more of an emphasis on taking risk-based approaches to the entire clinical trial process. Many companies are challenged by not having the appropriate risk frameworks in place. With new and emerging technology providers coming into the industry, it will become more challenging for companies that struggle with the fundamental aspects of quality and risk management.

I don’t think there is a lack of awareness around these issues; there has been discussion about them for years and light has been shed on the challenges. Yet, there hasn’t been significant movement or innovation around the way companies are partnering, and I think that’s what’s required. It’s not a static industry. It’s dynamic. But we haven’t seen an evolved approach to partnering. I think if you speak with executives on both the sponsor side and CRO side, they would echo some of these same concerns.

How is Avoca helping companies to tackle these issues?

We have been helping individual companies through our consulting and research projects. When I first launched the company, we began conducting a yearly research study where we gather quantitative and qualitative data on the health of relationships. In 2011 we did a deep dive into quality. The data was interesting and provocative. It led us to form The Avoca Quality Consortium® – a collaborative of pharma- and biotech companies and clinical service providers focused on helping to drive efficiency and help companies in the industry mitigate risk while also improving quality. Nearly 100 companies are now part of this consortium. Avoca utilizes our consultants and subject matter experts to do the heavy lifting of authoring leading practices and developing practical tools and templates aligned with clinical trial execution. Also, we conduct research with all our members.

One of the early initiatives, which was at the request of some of our members, was to create robust standards for qualifying clinical service providers. By leveraging our consortium construct, we have developed standard criteria for qualification that are mapped to regulatory guidance and we created associated tools like RFI (request for information) templates and visit checklists. We then put forward the idea of centralizing those business activities through a platform, and that’s how the Diligent® Qualification Platform came about. Diligent is a centralized, tech-enabled service offering that focuses on provider qualification. We ran a successful pilot with 13 pharma and biotech companies and 50 clinical service providers, where we centralized and managed the collection of hundreds of RFI requests. We also conducted multi-sponsor qualification assessments. This demonstrated value to both the sponsors and providers that participated. The centralized process not only addresses the dysfunction associated with redundancy; it also helps companies to increase compliance with regulatory guidance surrounding qualification, which has become stricter.

Now we are convening a small group of strategic partners who will commit to the centralized approach. It may take time for the entire industry to adopt the Diligent platform. However, we are gaining traction with companies that have significant outsourcing spends and so this will evolve over the coming year. I’m excited about the potential to drive cost savings with Diligent and, importantly, to shorten timelines for the launch of clinical trials.

It sounds like you’re an advocate of technology to solve problems like these. Are there any particular tech trends you’re excited about at the moment?

As the industry evolves, we will develop more patient-centric approaches to make it easier for patients to participate in clinical trials. And a problem that does need to be solved is that there simply aren’t enough investigational sites and experienced sites that are engaged in clinical research. As a result, I think we’re going to see an evolution in the next couple of years with patient-facing and site-facing apps, virtual and remote trials, that will change the way we do business and the way we engage with patients.  We’re also seeing that many companies have not established the right data infrastructures or approaches to qualifying or managing the new technology companies that are coming into the clinical trial space. Many companies are still trying to find their way with how to scale the use of digital technology in clinical trial execution.

Past Avoca surveys have covered quality and risk-based management. What would you anticipate the next topics might be?

We are going to look at technology and its rate of adoption, what issues companies are experiencing, and who might be considered future disruptors in the space. We will characterize the current challenges and opportunities and identify how clinical trials will evolve in the future. I think it’s helpful for individual companies to see the aggregate trend data, both quantitative and qualitative, because many companies are trying to find their way, thinking they’re the only ones struggling. It can be cathartic to see that there are common challenges especially since technology adoption is advancing very quickly. Our capability to keep up with technology and our understanding of how best to leverage it is not necessarily keeping pace with other industries, especially in areas like artificial intelligence. Even predictive analytics – which has been around for some time – is difficult to adopt when you have legacy systems that have been in place for many years, especially in large organizations.

I think the biggest challenge – and this may come out in our data – is that it’s not so much the technologies themselves but the culture shift and mind shift that are required from individuals and from clinical study teams. It requires a different way of working and a different way of thinking and that’s hard.

What solutions might be needed to tackle that?

I think the people issues are more daunting than some of the other things that we uncover as challenges. For example, when the new ICH E6(R2) regulations came out, there was a requirement to update processes and procedures to apply more risk-based approaches. That was the easy part. The hard part is the knowledge and learning gaps and thinking differently about how to execute these changes on trials.

As an industry, there needs to be greater sophistication around change management. From the outside looking in, I sometimes see a disconnect between the discussions happening at the senior executive level and what the study teams are experiencing. Much gets lost in translation between the senior executives and the people on the front lines of clinical trials. That needs to be acknowledged and addressed. In some companies, it’s well known and being worked on. In others, it’s a blind spot.

It seems that more sites are ‘one and done’. Do you think this disconnect is a contributing factor?

Yes, the one and done approach with study sites is a big issue for the industry. Without having the consistency of teams working together in an effective way, it’s difficult to keep starting all over again with a new set of key stakeholders.

I feel we need to make clinical trials much more appealing and accessible to more sites and we need to do it in a way that benefits patients. There has been a lot of progress made in putting forward the notion of clinical research as a care option and there is a closer connection between health care and clinical studies. I predict that with better standards around electronic health records and with the work that groups like Javara Research and Elligo Health Research are doing to integrate trials with healthcare there could be a shift that takes place in that area.

What’s the greatest change you want to see as a result of the work Avoca is doing?

Our goal is to have a positive impact on every clinical trial in the world. That sounds ambitious, but I feel that it is within our reach. The companies that we are supporting in our consortium represent the majority of activity in the clinical trial space. I would like for the work we are doing with our consortium to have a major impact on driving efficiency and reducing the duplication of efforts in traditional clinical trial execution. As clinical trials evolve, we will help the industry create “fit for purpose” quality and risk frameworks to enable success with digital and decentralized trials. There is still this tension between speed, cost, and quality and the tension will increase as trials become more complex and more decentralized. The consortium construct will help to address this in a very meaningful way.

Clinical Trial Leaders Interviews