Fear of Failure May Inhibit Innovation, Lack of Awareness May Inhibit Diversity Efforts

Posted in Process Improvement

Sponsors and CROs aspire to be more innovative and achieve greater diversity, but only a few have crossed the bridge from aspiration to practice; one reason may be a fear of failure. That’s just one of the take-aways of the 2020 Avoca Industry Report, which explored respondents’ perceptions surrounding innovation and diversity in clinical trials. Of the 229 respondents, 145 represented sponsors and 84 represented providers (mostly CROs). What follows is an overview of the highlights.

Are You Innovative?

In general, respondents appeared to be somewhat positive about their companies’ level of innovation. When asked, Overall, to what extent do you view your organization as innovative?”, respondents received a list of statements related to innovation and ranked themselves on a 1-5 scale. Overall, the mean scores were neutral to positive, landing in the low-to-mid threes.

However, when you dig deeper, an interesting pattern emerges: As the statements began to address actual implementation, scores fell. For example, “Recognizes and adopts innovations that appear likely to be successful” received the strongest positive response, while “My organization is willing to try and fail, an appropriate number of times, in pursuit of innovation” ranked the lowest.

Larger companies had more positive scores, and the small to mid-size companies had more negative ones. This may be explained by volume: The more trials a respondent had done, the higher the ratings with respect to innovation practices. Another interesting finding: Companies with greater trial volume are more likely to have been introduced to innovations through relationships with CROs. (An article on this phenomenon appeared in a recent issue of Life Science Leader.)

How Are You Innovating?

The survey asked about 35 innovations across four areas:

  • Use of artificial intelligence in protocol and clinical development plan design and planning
  • Use of non-traditional study designs and endpoints in protocols, clinical development, plan design and planning
  • Decentralized trial activities and patient engagement technologies
  • Data management, risk management, and monitoring activities

When asked about the types of innovations they could report on behalf of their companies, most identified those related to data management, risk management and monitoring. Approximately half were able to report on decentralized trial activities and patient engagement technologies. Fewer could report on use of non-traditional study designs and artificial intelligence.

Here are a few specific observations about each category of innovation:

Use of artificial intelligence: Despite a low adoption rate compared to other types of innovations, respondents’ perceptions of the impact of AI-related innovations on clinical trial quality were largely positive.

  • Top drivers of adoption: Accelerating timelines for individual clinical trials and for clinical development programs as a whole
  • Top challenges to adoption: Lack of understanding of the innovation and an unclear value proposition/uncertain ROI

Use of non-traditional study designs and end points: About half of respondents felt the impact of these innovations category to be generally neutral and most of the remainder perceived the impact to be positive.

  • Top drivers of adoption: Accelerating timelines for individual clinical trials and for clinical development programs as a whole
  • Top challenges to adoption: Regulatory challenges and a lack of understanding of the innovation

Decentralized trial activities and patient engagement technologies: Most respondents were positive about the impact on the retention and diversity of study participants, as well as on the streamlining of clinical development programs. However, about a quarter said decentralization presented risks to protocol compliance, participant safety and participant privacy.

  • Top drivers of adoption: Increasing study participant retention and increasing protocol compliance
  • Top challenges to adoption: Operational/process integration and regulatory challenges

Data management, risk management and monitoring activities: Perceptions of the impact on quality again varied. Most said these innovations benefited data completeness and accuracy, protocol compliance, the ability to interpret study data, and study participant safety. Attitudes on other aspects of quality tended toward neutral, but more than 15% indicated concern about risks to participant privacy and the amount of human and financial resources required.

  • Top drivers of adoption: Reducing operational risk and increasing data completeness and accuracy
  • Top challenge to adoption: Operational/process integration

Did COVID-19 Drive Innovation?

The survey attempted to tease out which innovations emerged as a result of the pandemic. Innovations most likely to have been adopted because of COVID-19 included ship-to-home of clinical supplies, remote source data review, remote source data verification, study visits via telemedicine, and remote review of electronic investigator site files. Most plan to continue using these innovations, at least to some extent. Those who were uncertain cited regulatory concerns.

Innovations most likely to have been adopted independent of COVID-19 included electronic patient diaries, risk-based monitoring/study management tools, application of AI to clinical trial data to more fully understand efficacy and safety, observational trials, using real-world data and adaptive trials.

Workforce Readiness and Innovation: A Mixed Review

When asked about workforce considerations vis-à-vis clinical research innovation, respondents were more confident in their own readiness than in their company’s readiness. Nearly half said they were comfortable about keeping their own personal skills and perspectives up to date, but only one-third were comfortable about their companies’ workforces overall.

Turning to Diversity: Still Waiting to Execute?

The diversity portion of the survey yielded some intriguing insights.

When survey respondents were asked to rate the importance of various types of diversity among clinical trial participants, their responses varied widely.

  • Diversity across global/regional standards of care and gender were most uniformly seen as critical
  • Racial representation came next, and there was a significant divide. Roughly 11% indicated that they didn’t consider it important
  • Opinions about diversity across economic strata and community types (rural vs. urban vs. suburban) were more varied but tended to come in at the bottom

This last point is notable because some research suggests racial differences in the delivery and quality of medical care may be a proxy for diversity by economic condition or zip code. To say one is important and the others are not, suggests that respondents see diversity as conceptually important, but they lack a deep understanding of the subject.

Two other findings also suggest that many respondents don’t fully grasp what’s happening in terms of diversity. First, when they rated their familiarity with various guidance documents, the FDA Guidance on Enhancing the Diversity of Clinical Trial Populations came in at the bottom. Notably, respondents were more familiar with the planned ICH E6(R3) whose draft principles have been released. Second, when asked how each of their own companies were performing in each category of participant diversity, many didn’t know.

Overall, in terms of participant diversity, respondents rated their own companies higher than the industry at large in every respect. This discrepancy may reflect the failure of communication across companies about practices and performance.

Moving Forward

In both the diversity and innovation questions, the responses are generally positive. But foundations required to execute effectively are not fully in place.

Looking across the areas we’ve discussed, the survey results reveal four challenges: lack of clarity around the value prop; lack of understanding of the technology; operational and process integration concerns; and regulatory challenges. The first three are ripe for improvement across the industry as a whole. We see that significant percentages of respondents have bridged that divide between aspiration and action, offering an opportunity for others to learn from their success by sharing insights and lessons learned. Through collaborative environments with a shared goal of developing pre-competitive tools and learnings, the industry can more rapidly begin to adopt these technologies and overcome the challenges identified in the survey. The WCG Avoca Innovation Alliance (AIA) was launched in 2020 to begin addressing these challenges as we move toward a next generation clinical trial execution model. If you are interested in joining, please contact us.

View the webinar recording reviewing Avoca’s 2020 Industry Research on Innovation and Diversity, “How do we finish what COVID started?” ›

Learn more and access the The 2020 Avoca State of the Industry Report: Innovation by Fire, Diversity, and the Next Normal ›