Guest Column | August 17, 2017

The Changing Landscape Of Clinical Trials: How Leaders Should Respond

By Patricia Leuchten, CEO, The Avoca Group

The past several years have brought significant changes to the clinical trial landscape.  Mergers and acquisitions, new players, the rapid proliferation of technology, increased patient advocacy, and new regulatory guidelines have added to the complexity of trials and burdened resource-strapped leaders with additional challenges and risks.

Executives who are busy running trials don’t always have the chance to step back from day-to-day operations to examine the whole landscape, understand how it affects them, and plot a strategic response.

To fill this need, The Avoca Group conducts annual surveys of sponsors and providers on timely issues in clinical outsourcing. The surveys are meant to help leaders navigate the landscape of clinical trials. The 2017 survey focused on risk. More than 300 respondents participated, providing balanced feedback from sponsors and providers both large and small. Specifically, the survey focused on how sponsors and providers work together on risk assessment and their comfort level with risk-based approaches.

Avoca also hosts yearly summits to discuss the most pressing developments in the field. Held under the auspices of the Avoca Quality Consortium (AQC), which gives members a channel for keeping abreast of key topics, the summits provide color and context to many of the issues addressed in the surveys.

Both the surveys and summits enable us to map the clinical trials landscape and understand what’s changing. What have this year’s survey and conversations unearthed? That evolutions in risk, inspections, collaboration between sponsors and CROs, oversight, and patient-centricity are the top items on leaders’ minds.

This year’s survey asked about knowledge of best practices in managing risk, keying in on four areas of risk management: quality management, site monitoring, provider oversight, and inspection preparedness. Providers and sponsors alike voiced similar understandings of best approaches to provider oversight and inspection preparedness. Approximately one-third of sponsors reported having only “fair understanding” to “no knowledge” of these approaches in all four groups. On the other hand, providers expressed somewhat greater familiarity in approaches to quality management and site monitoring.

As we explain below, such differences indicate a need for greater cooperation, communication, and ultimately, collaboration among providers and sponsors — in the interest of improving the quality of clinical trials and getting medicines to patients sooner.

Changes in all these areas have important implications for how leaders in clinical trials operate. Leaders, we believe, need to reallocate resources to risk evaluation and planning before a trial starts. There has historically been an emphasis on speed to start-up, during which issues are ignored or tabled in order to meet timeline goals. Refocusing efforts on proactive quality management, however, is a change in mindset that leaders in clinical trial operations need to embrace.

Changes In The Landscape Of Risk And Inspections

When asked what has been most challenging in using risk-based approaches to clinical trials, respondents cited “aligning people and thinking” as well as “aligning systems and processes.”

Inspections have been a fixture of the trial landscape for decades. However, the recent changes in regulatory guidelines — coupled with inconsistent interpretations of rules by inspectors — have led to significant anxiety and, in some cases, increased costs.

Complicating the matter are the recent revisions to GCP guidelines, which cover risk-based approaches to trials. At our recent summits, we asked attendees who was ready for ICH E6 R2, and only a few hands were raised. Companies are struggling to fully comprehend these new regulations, and they’re not sure how best to comply.To address many of the industry’s challenges, AQC developed a regulatory roadmap of certain approaches to clinical trial conduct to ensure all are on the same page in clinical outsourcing strategies, regardless of their role as sponsor or provider.

Meanwhile, we’ve learned that sponsors are looking for ways to assess their clinical operations teams’ ability to oversee providers. Years of feedback from the industry show that a strong provider oversight program correlates to stronger partnerships, more aligned processes, and better ability to meet timelines. In addition, strong oversight programs align expectations and thresholds that require action. Alignment in this area is a key focus of ICH E6 R2, and by implementing and continuously improving these processes through risk-based approaches, sponsors and providers set themselves up to be compliant with the new guidelines and in a better position should inspections occur.


Collaboration between sponsors and CROs is particularly crucial in risk assessment and risk management. To work together effectively, both parties need to share mutual expectations. They need to communicate clearly. And they need to have a common understanding of what constitutes risk, and how to mitigate it.

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Both groups have made progress in this area. But there’s work to be done, especially when it comes to gaining alignment on risk-based approaches. In fact, this year’s survey found some telling disconnects between sponsors and providers.

  • While 71 percent of providers believe they have the ability to support their company in using a risk-based approach to prepare for inspections, only 37 percent of sponsors feel the same.
  • 74 percent of providers are satisfied with the level of innovation and technology in the areas of risk-based monitoring and risk-based quality management, whereas only 34 percent of sponsors say they are satisfied.
  • 73 percent of providers are satisfied with the level of expertise and experience in applying risk-based approaches to quality management overall. For sponsors, the figure is 33 percent.

Despite the differences, respondents to the survey realize just how crucial it is to have productive collaborations with external partners. One survey respondent noted, “The ability to create trust and collaborate are pivotal in getting closer.” Another wrote, “Regardless of the type of partnership, it is important to define what win-win looks like. We do RFPs, discuss prices, agree on scope of work, but don’t talk about culture, value, and partnering.”

Patient Centricity

No discussion of the clinical trial landscape is complete without a conversation about patients. Patient centricity has been prominently featured in conferences and industry discussions. But lack of a clear definition of “patient engagement” and an absence of clearly articulated benefits all impede progress in partnering with patients in a meaningful way.

Key stakeholders agree that the era of the empowered patient is here to stay. They welcome guidance on how best to engage patients in a simple fashion before, during, and after clinical trials.

The availability of guidance and tools from organizations such as the Center for Information and Study on Clinical Research Participation (CISCRP) and the Clinical Trials Transformation Initiative (CTTI), as well as Avoca’s Patient Engagement Playbook, are all seen as welcome, much-needed assistance to re-engineer patient involvement in clinical trials in an impactful manner. As one survey respondent noted, “Patients are not interested in helping pharma sell more drugs, they are interested in helping them make better drugs. Ask them to be collaborators.”

How To Respond

How should executives respond to current challenges in risk and inspections, collaboration, and improving patient engagement? Taking each in turn, we offer the following suggestions.

Risk And Inspections

  • Through insights gained from sharing of experiences and tips relative to diverse regulatory agency approaches to inspections, develop strategic risk-based approaches to ensure their organizations and partners prospectively focus on inspection preparedness.
  • Foster a culture — in their organization and with their partners — that focuses on building in quality up-front with complete, accurate, timely, and traceable electronic documentation.
  • Ensure their organizations are fully aware of changing regulations such as ICH E6 R2 and 21 CFR Part 11, and devote the necessary resources to rapidly adapt and engage in change initiatives that will prepare them to achieve compliance long before inspections occur relative to the new guidelines.


  • By recognizing the need for quality as a pre-competitive industry requirement when conducting clinical trials, continue to break down silos and barriers.
  • Share leading practices.
  • Continue to establish standards in practice that permit providers and sponsors to align on requirements and approaches for quality.

Patient Engagement

  • Clarify the specific problems you’re trying to solve or goals you’re trying to achieve. Plan your patient engagement programs accordingly and measure their success.
  • Thoroughly explore what your current or potential vendors/partners have to offer in this area, to take advantage of their resources, capabilities, experience, and expertise.
  • Don’t restrict yourself to starting patient engagement activities during the busy trial start-up phase. Instead, consider launching patient engagement activities even on trials that have already begun, or outside of the context of the clinical trial altogether.
  • Seek the input of caregivers, who play a major role in patients’ lives during trials. Do likewise with principal investigators (PIs). Their involvement is key to patient enrollment and retention.


In a rapidly evolving world, the challenges faced in clinical trials are only expected to increase. As a result, proactive collaboration among sponsors and providers — and an investment in streamlined, shared processes — is more important than ever. We also need to take active steps to involve patients in the process, giving them and their caregivers a greater voice in the clinical trial process.

Making strides in these areas will go a long way toward equipping and enabling the industry to innovate and accommodate the changing landscape of clinical trials, and to bring drugs to patients in a sustainable, efficient manner.

About The Author:

Patricia Leuchten has more than 25 years of experience in the pharmaceutical industry and is a leading authority on global clinical outsourcing and strategic alliances.

In 1999, Ms. Leuchten founded The Avoca Group, a consulting and research firm specializing in clinical outsourcing, alliance management, and quality management in outsourced clinical trials. The Avoca Group has played an important role in the industry as the first consulting firm to track trends in clinical outsourcing and to measure the health of relationships between sponsors and CROs.

Ms. Leuchten launched the Avoca Quality Consortium in 2011 to encourage the sharing of leading practices and to bring sponsors and CROs into greater alignment. Since its inception, the consortium community has advanced collaboration on improving quality, mitigating risk, and increasing efficiency in outsourced clinical trials.