Assessing Investigative Site Outlook and Operating Experience Post-Pandemic

Introduction

During the past several years, in the wake of the COVID-19 pandemic, investigative sites have faced unprecedented challenges executing clinical trials. In additon to administering more complex protocols, finding patients under more stringent eligibility criteria, and retaining patients under more onerous participation requirements, sites have had to accommodate the use of a variety of remote and virtual technologies to collect and manage clinical trial data. At the same time, chronic operating challenges including inadequate study budgets, protracted contract negotiations, punitive hold-back payments, and poor CRA quality and continuity have continued to plague investigative sites. And recently, investigative sites have encountered higher levels of staff turnover and shortages.

The Tufts Center for the Study of Drug Development (Tufts CSDD) recently conducted a survey to understand the current mindset, experience and outlook of a global community of investigative sites. The survey endeavored to garner the perspectives of the “typical” investigative site and to understand variation in perspectives and experience by site type and by personnel function.*

This article presents highlights of the survey results and offers insights into ways that sponsors and CROs can strengthen their relationships with sites in this current, post-pandemic clinical trial operating environment.

Survey methodology and data characteristics

The survey was conducted online between October and December 2022. To reach a global community of investigative sites, Tufts CSDD used proprietary contact lists and partnered with the Association of Clincial Research Professionals. A total of 205 responses were collected.

The majority of respondents are employed by integrated clinical care/research sites (81%), and the remaining (19%) are employed by dedicated sites/site networks. 64% of respondents held a clinical site staff role and 36% held an administrative role. Clinical staff included roles such as PIs or Sub-Is, Clinical Research Coordinator (CRCs), and Clinical Research Nurses (CRNs) whereas administrative staff included site directors, research managers or equivalent roles.

Overall,respondents were experienced with a mean tenure in clinical research of 17 years with a range of less than one year up to 50 years working in the industry.

While the majority (70%) of respondents is employed in North America/Central America, 16% are employed in Europe, 10% in Asia (10%) and 4% in other regions of the world (Table 1).

Table 1. Respondent characteristics

Primary challenges

In general, the majority of respondents reports that many study start-up, execution and other operating activities have worsened substantially over the last 5 years (Table 2). Some of these challenges are related to the COVID-19 pandemic whereas others are long-standing issues.

Hiring and retaining staff topped the keylist of primary challenges with budgets and contracts as well as study initiative activities a close second and third. Interestingly only 42% of respondents feel that implementing new technology had worsened somewhat or greatly. These findings are in contrast to some other recent site surveys where technology-related factors appear to have a bigger impact on site operations.¹

No significant differences are observed by site type, although it is noteworthy that only 20% of respondents from dedicated sites/site networks feel that interacting with sponsors had worsened compared to 35% of respondents from sites where research is integrated with clinical care. Administrative staff hae more positive views about sponsor interactions than do clinical staff.This could perhaps be a result of the investments sponsors have made engaging sites through professional research sites through various industry collaborations such as through SCRS, ACRP, TransCelerate, and the type of site staff who participate in these initiatives.

Table 2. Perceived change in site operating activities during the past five years by site type and role

Unsurprisingly, site staff who feel that things have worsened substantially over the last 5 years have a more pessimistic view of the future outlook of clinical research at their site in the next five years. Conversely, site staff who feel these operating activities have not worsened greatly or somewhat over the last 5 years, have a more optimistic viewpoint.

Site optimism and factors driving the optimism

The results also reveal that nearly 80% of respondents hae a ‘Somewhat’ or ‘Very Optimistic’ view of the future (Table 3).

Table 3. Optimism* for the future overall and by site type and respondent role

*Question: My outlook for the future of clinical research at my investigative site over the next five years

No significant differences are observed by site type or role although administrative staff reports being very optimistic in somewhat higher proportion compared to the clinical staff. One interesting finding is that site staff with less tenure have a more positive outlook than more experienced staff although the differences are not statistically significant (Figure 1). This may be explained by the fact that less experienced staff have a limited baseline on which to compare trends. Similarly, more seasoned veterans may have become more jaded in their attitudes or are more frustrated with the lack of progress in some areas.

Figure 1. Viewpoints based on tenure of clinical research experience

The most astonishing finding however, was the degree to which sponsor-site relationships affect positive or negative perceptions; specifically the degree to which sponsors seek, value, and apply site feedback is significantly related to site optimism about the future. Higher percentages of respondents who agree that sponsors seek (87%), value (86%), and applied (87%) site feedback are optimistic about the future (Table 4).

Table 4. Relationship between site optimism and perceived degree that sponsors seek, value and apply site feedback

Those that felt that sponsors they work with value input even if they are unable to apply it are over 4 times more likely to be optimistic about the future. Similarly, those that perceive that the sponsor applies site feedback and those that feel the sponsor seeks out site feedback are over 3 times more likely to be optimistic about the future. Several respondents underscored this point, noting that:

“Soliciting and implementing changes based on the feedback of experienced sites would help sites succeed in implementing study protocols and likely would prevent many failed trials.”

—Site director

“Sponsors who do not ask for feedback from study coordinators regarding study design and feasibility generally have poorly designed, non-feasible studies. Sponsors should seek consultation from study coordinators, as we are the ‘boots on the ground’ and can tell a sponsor if something does not appear to be doable or will be too much burden on participants and/or study staff.”

—Clinical research coordinator/site director

Even if site feedback cannot be incorporated, respondents value hearing from sponsors that their feedback was considered.

Patient centricity and site centricity are one and the same

Overall sites feelthat more traditional patient-centric services such as pre-paid debit cards and transportation assistance programs have a much greater impact on a volunteer’s willingness to participate in clinical trials than some of the newer approaches (Figure 2). Over half of the respondents feelthese had a greater influence compared to remote visits, home-health services or local pharmacy-based visits.

Figure 2. Solutions that greatly enhance volunteer participation

Nonetheless, respondents feelthat overall, any of the DCT-related solutions aimed at enhancing volunteer participation also enhance site implementation success (Figure 3). These findings suggest that if the site perceives a solution will enable their success and if they are bought-into the solution, then it may translate into enhanced volunteer participation. Or, at a minimum, a perceived positive influence on participation rates.

Figure 3. Perceptions of impact of DCT-related solutions on participation and site implementtion

One industry expert noted that “the most patient-centric thing sponsors can do is to be site-centric.” The results of the Tufts CSDD survey support that observation.

Supporting healthy sponsor-site relationships by tackling age-old issues

Nearly every industry survey on site perceptions reinforces the importance of addressing the enduring challenges of study budgets, CRA quality and study complexity.^2,3 The results of this study were no exception (Figure 4).

Figure 4. Top factors that greatly enhance site sustainability

When asked which factors would greatly enhance the site’s likelihood of remaining in business going forward, the number one factor, reported by two-thirds of the respondents, is ensuring that study budgets reflect the true work efforts of the site. This is likely related to the intensity and complexity of the study as well with nearly half of the respondents suggesting that reduced intensity could facilitate better study implementation and future site viability. As one respondent noted:

“The resources to implement procedure-intensive studies are just so limited it would be great to have sponsors think carefully about what matters in getting the drug approved.”

—Site director

Similarly, over half of the sites also reinforce the qualifications of the CRAs/monitors as having a great influence on the viability of clinical research operations in the future. This was reinforced by another respondent who commented:

“If we were able to significantly increase the number of competent monitors for clinical trials, I think a large number of the issues that we face would dissipate.”

—Site director

There were some significate differences noted between clinical and administrative staff for each of these factors with administrative staff ranking all of these factors as having a greater influence than the clinical staff. This speaks to importance of tailoring site interactions to address the needs of the different roles.

While these themes were reinforced through a vast number of qualitative responses, one site director summed it up most succinctly:

“Sponsors, respect sites.”

—Site director

Summary and conclusions

It stands to reason that sites who feel respected and heard by sponsors will have a more optimistic view of the future. What may be less intuitive however, is the importance of pairing investments in new technologies with investments in behaviors that foster relationship quality with site staff, particularly more seasoned veterans. Simply focusing on novel approaches to conducting trials or implementing new technologies will only go so far in terms of becoming the sponsor of choice or accelerating clinical trials. Site staff who feel heard and that their experiences are valued, may withstand any number of burdensome procedures, novel technologies and procedure-intensive studies.

The results of this survey suggest that it may be less about the complexity of the study design, implementation model, or use of a given technology and more about the relationship the sponsor has with the site (in general) and specific roles at the site (administrative versus clinical staff).In addition, focusing on persistent challenges related to the adequacy of study budgets and CRA quality may have a greater impact on both the quality of the site relationship, as well as study performance.

In upcoming research, we hope to further explore the extent to which the qualitative aspects of sponsor-site relationships impact site performance and the adoption of new solutions supporting clinical trial execution.

*For this study, Tufts CSDD differentiated two site types: one that integrates research activities withing clinical care settings including not-for-profit clinics, hospitals, health systems, academic and government-affiliated hospitalsystems, and for-profit clinics and hospitals that provide clinical care and also conduct clinical research studies; and the other that conducts clinical trials within a dedicated site(s) / site networks and that derives the majority of their income from industry-funded clinical trial study grants.

Beth Harper, MBA, Abigail Dirks, BS, and Ken Getz, MBA, Tufts CSDD, Boston, MA, USA

Acknowledgements

We would like to acknowledge the following individuals who provided input into the survey design or shared their insights on the results:

Jessica Fritter; associate faculty, clinical instructor of practice, The Ohio State University College of Nursing, and partner, BJE Consultants

Victoria DiBiaso; global head, patient informed development & health value translation, Sanofi

Joseph Kim; chief strategy officer, ProofPilot

Therica Miller; executive director, enterprise cancer clinical research, Tisch Cancer Institute at Mount Sinai

We would also like to acknowledge the Association of Clinical Research Professionals (ACRP) for distributing the survey to their members.

References

1. Scott, J. Sites Name Tech Acceptance as Essential Factor in Selection of Sponsors, Survey Finds. CenterWatch. 2018. Published online: January 16, 2023.
2. AVOCA, ACRP. Becoming a Sponsor or CRO of Choice – A Site Perspective. White paper published online: September 2018.
3. SCRS. Site Perspectives on Decentralized Clinical Trials. White paper published online: 2022.