Cristin MacDonald, PhD

The acceleration of drug discovery and development has taken on even greater importance as we face a third year of the COVID-19 pandemic. The industry has responded by incorporating remote monitoring techniques and fast-tracking the use of hybrid and decentralized clinical trial (DCT) models, at a pace never seen before. To sustain the momentum on these and other innovations that support study execution, we have also seen the rise of the #NoGoingBack initiative which aims to ensure that the progress made doesn’t fade when the pandemic finally fades.*

Despite these short term achievements, it is still taking more than 20 years to reach industry-wide adoption of various technologies and innovations that could prove beneficial to clinical research operations. Interactive Voice Response Systems (IVRS) and Electronic Data Capture (EDC) solutions were introduced in the late 1980s and early 1990s but these are only now reaching wide adoption

 by sponsors and CROs. Electronic Patient Reported Outcomes (ePRO), Electronic Clinical Outcomes Assessment (eCOA), and eSource technologies, while introduced in the mid to late 1990s, have yet to achieve wide adoption.

 This pattern holds true for risk-based monitoring, digital health outcomes, and other innovative approaches and solutions. While these innovations offer great promise, their potential can’t be realized if it takes two decades or more for them to be fully embedded into the drug development process.

In a first attempt to understand the factors impacting technology adoption, a 2020 Tufts CSDD study revealed that financial and regulatory concerns topped the list.

 Lack of trust in the technology was also reported as an important factor in that study. Additionally, it also revealed that organizational culture and senior leadership’s approach presented significant challenges to the process of technology adoption.

To gain further insights into the barriers to and opportunities for accelerating innovation adoption at both the industry and company levels, the Tufts Center for the Study of Drug Development (Tufts CSDD) undertook additional research in 2021. The purpose of this research is to characterize the long term adoption experience of technologies and capabilities supporting clinical trial execution. This research takes a long term view, and since we have yet to see the permanence of the changes that are taking place during the Covid-19 pandemic, these changes were not the focus of this research.

The research comprised informational interviews and an online global survey of biopharmaceutical executives and clinical research operations personnel. The research was completed in collaboration with WCG Avoca and seventeen biopharmaceutical sponsors who formed the working group (WG) participating in the project.

This article will provide some high-level findings from the research with a focus on actionable steps that biopharmaceutical executives can take to foster and support the adoption of innovations within their companies, namely:

Instituting mandates for greater operational efficiency

Greater support, involvement and engagement by senior leadership throughout all stages of the innovation adoption process

Offering incentives and recognition—and eliminating penalties—to individuals who promote innovative behaviors, approaches, and technologies within the organization; and

Implementing better change management, planning, and communication activities early on, and throughout the process.

The Primary stages of innovation adoption

Two predominant models exist that provide context for how innovations are adopted. The first model is the Gartner Hype Cycle, developed by Fenn in 1995. The second model is known as the Innovation Diffusion Model, developed by Rogers in 1963.

The initiation stage involves identification of the need to try a different technology, process, system, or approach to optimize clinical trial execution. This is where organizations gauge the interest and start the initial planning for trying or testing out an innovation. This is followed by the evaluation phase, which typically involves pilot projects or other assessments of the potential innovation. Based on results from the evaluation phase, organizations typically go through a decision-making process to either abandon or move forward with enterprise-wide adoption of the innovation. This is finally followed by a series of communications and training activities in support of broad implementation of the innovation throughout the organization.

These models informed the development of an interview guide and global survey. Twenty interviews were conducted with various stakeholders from the working group’s member companies. The interviews provided insights into the stages and decision-making processes that sponsor organizations follow to identify and evaluate potential innovations in the clinical development process. The findings from the interviews then shaped the creation of a global survey. The survey was organized into four key stages of the innovation adoption process, namely, initiation, evaluation, adoption decision and full implementation (Figure 1).

Figure 1. The Biopharma Innovation Adoption Cycle

Survey methodology and data characteristics

The survey was primarly structured according to this four-step process with questions aimed at further understanding the process of adoption for new processes, systems and/or technologies that are transformative in terms of how the industry designs, plans, executes and manages data supporting clinical trials. Specifically, respondents were asked to consider innovations that are still emerging and haven’t yet reached industry-wide adoption. Illustrative examples were provided for reference and included eSource, eConsent, Risk Based Monitoring (RBM), Digital Health Endpoints and AI capabilities.

The survey asked respondents to characterize the timeframes for going through the various stages, the functional groups involved in the process, the types of quantitative and qualitative information used to advance from one stage to the next along with key challenges and barriers associated with each stage. Broader questions related to perceptions about how companies fared in their innovation adoption approach compared to others, and about how respondents viewed their company across the innovation diffusion model—innovator to late adopter or laggard—were included. The survey also captured perceptions of how the pharmaceutical industry compared to other industries when it comes to speed of innovation. Finally, the survey focused on opportunities for accelerating the innovation adoption process.

A total of 552 responses were received from a global audience primarily representing pharmaceutical and biotechnology companies. Approximately six percent of the respondents were from CROs or other organizations; however, responses from these individuals were not included in the primary analyses. Just over half of the respondents (53.9%) worked across large sponsors with 28% working at mid-size companies and 18.1% at small biopharma.

Nearly half of responses (49.3%) were received from individuals whose company headquarters were in Europe. 38.8% and 12% of responses were received from respondents with company headquarters based in North America and Rest of World (ROW), respectively.

A variety of roles were also represented, including professionals from Clinical Operations (46%); Clinical Development (9%); Innovation Management (17%); Data Science & Data Management (10%); Information Technology (3%) and 15% from other roles. About half (51%) of respondents reported that they had some influence on the adoption decision making process, with 30% indicating they had little to no impact on the decisions. 19% of respondents indicated that they were key decision-makers when it comes to the process of pursuing, evaluating, or implementing innovations in their organizations. Finally, 14.5% of respondents were part of a centralized or dedicated innovation group whereas the majority (85.5%) worked outside of such an innovation group.

Over two-thirds (69%) of respondents indicated that the adoption process within their organization generally followed the four-step approach as outlined above (Figure 1). Where the process differed, respondents indicated that there was no formal process, or that certain steps were less defined or skipped altogether. Interestingly, some respondents from smaller companies reported having staff with experience at large companies where things were “overprocessed”, and have therefore made the decision to eliminate the process altogether. These companies intentionally decide to move straight into implementation, preferring to sort out issues along the way rather than formalizing the method and/or metrics by which they evaluate and implement an innovation.

Thus, responses reflect a broad crosssection of views and perspectives from which to learn more about how the biopharmaceutical industry approaches the innovation adoption process, what gets in the way and how organizations, and the industry more broadly, can accelerate new technologies and innovations.

The survey results revealed that within individual biopharmaceutical companies the average innovation adoption cycle for a given clinical operations innovation lasts about 6 years. The longest reported cycle lasted 10 years with the shortest lasting 1.5 years (Figure 2).

Figure 2. Average Duration of Stages in the Biopharma Company’s Innovation Adoption Cycle

Cycle times varied by company size. Small biopharma reported the fastest cycle times and mid-size companies reported the longest (Figure 3).In general, the time to complete each stage increased across the four stages with the initiation step being the shortest and the full implementation stage taking the longest. The high coefficient of variation (CV) suggests wide variation in the length of each stage of the innovation adoption cycle.

Figure 3. The Biopharmaceutical Innovation Adoption Cycle by Company Size

When it comes to the impetus to pursue or explore an innovation, the results suggest that the primary factors are (1) a new or updated regulatory guidance, (2) an operating objective to improve the speed of clinical development, or (3) a mandate from senior management to pursue an innovation (Figure 4). The support and advocacy of senior leadership along with regulatory compliance and approval considerations were also big drivers of the decision to progress to the next stages. Financial considerations were among the top three drivers during the evaluation, adoption decision, and full implementation stages. The presence of change management strategies played a key role in the decision to move forward with full implementation.

Figure 4. Key Factors Driving the Progression of Stages in the Innovation Adoption Process

When asked about barriers and challeges, study participants reported that the easiest stages to complete were the earlier stages of the process (initiation and evaluation) with the adoption decision and full implementation stages being the most challenging (Table 1).

Table 1. Perceived Difficulty of Stages in the Innovation Adoption Cycle

Some interesting themes emerged in the analysis of barriers to completing or advancing to the next stages of the innovation adoption process. Key themes include:

Specifically, employee turnover and lack of cross-functional alignment are key factors that play a role across most stages. The lack of senior management involvement and support was identified as a key barrier at the evaluation and full implementation stages.

The lack of regulatory clarity and need for legal review and approval of the given innovation were reported as barriers across all stages indicating that companies like to ensure legal and regulatory acceptability prior ot moving to the next stage.

Financial constraints were noted as barriers in the three later stages, but were not reported as an issue impacting the initial pursuit of a potential innovation. Interestingly, the misalignment of incentives was also noted as a key barrier through the three later stages as well. This comes in the form of lack of rewards or recognition for exploring and advancing new ideas and the perceived risks associated with not meeting deadlines or budgets.

During the evaluation and adoption decision stages, difficulties in comparing vendors and uncertainty about the viability of a given vendor factored more heavily into the process to advance to the next stage, compared to vendor related considerations in the initiation or full implementation stages.

The absence of change management strategies and planning were identified as important challenges at the beginning and end stages of the process.

Opportunities to accelerate adoption of innovations

Many of the challenges and barriers noted by study participants are actionable.While there is recognition that greater regulatory clarity would be helpful in accelerating the process, this is often outside the direct influence of senior leadership (but something that regulatory agencies could do to facilitate more rapid adoption of new innovations). Nonetheless, respondents identified many opportunities for improvement in areas related to personnel, finances and incentives, and operations.

Senior leadership’s presence and support throughout the process

The most striking finding is that visible senior management support and promotion of an innovation throughout all stages of the process can lead to its faster adoption. Repondents echoed the signifincance of senior leadership mandates—as well as their presence and engagement at all stages—in improving the speed of innovation adoption. These perceptions align well with the correlations observed between companies with shorter timelines and the presence of senior leadership at each stage of the adoption cycle. Those companies that had senior leadership involvement at all stages also showed shorter timelines compared to those without. The mandates and support of senior leadership, coupled with the establishment of operational objectives to improve the speed of clinical development, can lead to shorter adoption cycles.

It is important to note that active, visible involvement and encouragement by senior leadership is currently a key factor in the speed of innovation adoption because the decision-making power on matters that affect innovation adoption tends to reside exclusively with this select group. An alternative approach that has been looked at, particularly within larger organizations, and which warrants further investigation is one where this decision-making power—and the accountability that follows it—is adequately distributed among teams and individuals throughout the organization.iv This approach could offer companies the ability to adapt easily, and to quickly make decisions that directly impact the speed of innovation adoption.

In a similar vein, company leadership are encouraged to continue to develop a culture of innovation within their organizations and across industry. Our research showed that nearly half of the respondents (42%) indicated either high or moderate risk to their performance review when pursuing adoption of an innovation. Thus, leaders are encouraged to build incentives for participating in the innovation adoption process into individual performance reviews.Offering incentives and recognition for the pursuit of a new approach instead of only holding individuals accountable for adherence to study timelines and budgets tends to be correlated with higher satisfaction with the innovation adoption process within biopharmaceutical companies. Providing adequate funding, resources and financial incentives to these individuals so that they can explore, pilot, and drive the adoption process can lead to quicker innovation adoption timelines. Additionally, leaders should be mindful of inadvertently penalizing individuals who develop, champion, and/or try new ideas, approaches and technologies.

Another important element for the development of a culture of innovation is the presence of a change management strategy. Study participants reported that change management strategies and communication planning play significant roles in fostering faster adoption. Waiting for the full implementation stage to think through how the organization will use, integrate, and manage a given innovation may hamper its rapid adoption.

An important outcome of this research is that substantive differences in cycle times were not identified between companies that have a dedicated innovation group compared to those that don’t. Intuitively, the presence of a dedicated innovation group would lead to faster cycle times or fewer challenges in the later stages of the process; this hypothesis was not validated here, however. Interestingly, respondents from smaller biopharma companies suggested in high proportion that innovation groups could help accelerate the adoption process. These were also the same companies that reported the presence of innovation groups in the lowest proportions compared to mid-sized and large pharma, while reporting the fastest timelines. The faster timelines observed at smaller biopharma might be explained by their greater reliance on CRO partners, the smaller scales in which they work, and their high degree of specialization in one or few therapeutic areas, among other factors. This topic warrants further investigation and is an area that we hope to explore further in future research.Based on our extensive review of examples in the literature, the stages of the innovation adoption process, and the durations and challenges, are consistent with those encountered by similar, highly regulated, research intensive industries.

The industry may be missing out on key opportunities to accelerate drug development through a lengthy and inefficient process for evaluating and adopting innovations. Cross-company collaborations, partnerships with CRO and vendor partners, and regulatory guidance and clarity can support broader industry-wide adoption of innovations.We recognize that the rapid adoption of DCT solutions during the pandemic was facilitated in part by unprecedented proactive and accommodating regulatory agency involvement

At the company level, this research found that full implementation of a new technology or process in clinical operations can be achieved in under two years. Through mandates, senior leadership involvement, cross-functional engagement, financial support, better alignment of incentives, and improved change management and planning, biopharmaceutical companies can be more proactive and intentional about the way they explore and pursue innovations.

We would like to acknowledge the study’s Working Group for their contributions to this research.

*In this research we are defining “wide-adoption’ as approximately 70% of industry having decided or being in the process of fully adoping the technology or capability.

https://www.outsourcing-pharma.com/Article/2020/10/29/NoGoingBack-mission-brings-trial-pros-together

Tufts CSDD Analysis, presented at Veeva R&D Summit, June 10 2019, Barcelona, Spain

Tufts CSDD White Paper – Adoption of Innovative Technologies within Pharmaceutical R&D, May 2020

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