Beth Harper

How can we restore and build trust between minority patients and clinical trial researchers? And how can doing so transform healthcare by helping clinical trials better serve the broader population? These are important questions that deserve our time and attention.

The low levels of participation of minority populations in clinical research are clear. Numerous sources have, for years, cited the underrepresentation of ethnic and racial minorities in clinical trials. While the statistics vary, they are very stark in nature with significant underrepresentation by non-white populations reported across multiple sources.

 Even more discouraging are the findings from a recent report by the Tufts Center for the Study of Drug Development. They found that nearly 20% of all drug and biologic approvals between 2007 and 2017 were missing data on participant race for all referenced pivotal trials and that 50% of drug approvals did not include participant ethnicity data on any of their trials.

SubjectWell has been collecting statistics on how race and gender impact clinical trial participation and patient sentiment during the COVID-19 pandemic. The latest findings from a June survey of 553 respondents suggest twice the number of African Americans (26%) versus Caucasians (13%) feel “not at all likely to consider participation in a clinical trial for a condition other than COVID-19”.

 Further, 56% of African Americans responded they would be “very concerned about COVID-19 exposure when taking part in a clinical research study” versus 31% of Caucasians. And this is but one of the groups tracking and reporting trial participation data of minorities in COVD-19 vaccine trials.

COVID-19 has made the importance of promoting diversity in clinical trials even more clear. The pandemic has thus far disproportionally impacted minority populations, and our ongoing failure to adequately represent all patients regardless of demographic background has never been more important to remedy than it is today. Underscoring this is the fact that Moderna Therapeutics, a leading contender in the race for a vaccine trial, recently announced it is slowing enrollment in the COVE Phase III trial.

The enrollment slowdown is meant to ensure Moderna has enough minorities, who are most at risk of the disease.

The consequences are serious—the lack of participation in clinical trials by minority populations weakens the clinical data used by healthcare professionals to determine the best treatment programs and areas worthy of further study. The U.S. Food and Drug Administration (FDA) recognizes this critical shortcoming and encourages minority populations to join clinical trials. According to one FDA source, “Participants in clinical trials should represent the patients that will be using the medical products though this is often not the case. Racial and ethnic minorities are underrepresented in clinical trials.

Numerous attempts have been made by the industry over the last few decades to expand communications with minority populations to increase clinical trial participation. Success has been limited and fitful. Unfortunately, broader health inequities, a deep-seated wariness about clinical trials, and other factors have stymied meaningful progress. It’s long past time to try a new way of tackling the problem.

The Association of Clinical Research Professionals (ACRP) believes that by fostering a more diverse clinical research workforce, we can change this dynamic and promote diversity in clinical trial participation. Studies show most people who join clinical trials either learn about them from a healthcare practitioner or family member. Increasing diversity in the clinical research workforce is the first step in gathering better clinical data for minority health decisions.

The Multi-Regional Clinical Trials Center of Brigham and Women’s Hospital and Harvard University, a research center addressing critical issues in the conduct and oversight of clinical trials, recently issued a report noting,“Efforts to increase the diversity of the research work force should be prioritized. A workforce that is able to relate, empathize, and communicate with patients is better able to build trust and to connect with and provide care for potential study participants.” The report further suggested, “a clinical research workforce that is diverse itself is better able to prioritize, connect, care for, and successfully recruit a diverse participant population in research, and collectively we should strive to diversify the workforce”.

In 2019, ACRP’s Partners in Workforce Advancement (PWA), a collaboration of clinical trial sponsors, research organizations, investigator sites, academic institutions, the National Institutes of Health (NIH) and FDA, launched an innovative pilot project, 

a digital media campaign to raise awareness of the clinical research profession among a diverse population of students. The goal: to grow and diversify the clinical research workforce, ultimately impacting the diversity of patients in clinical trials and expanding medical evidence for diverse populations. The clinical research industry offers high-paid jobs that often only require an associate degree. A report published in June 2020 by ACRP and TEConomy Partners, LLC, assessing the clinical research workforce “reveals a profession driven by high-quality jobs with significant demand from a growing clinical research industry and opportunities for entry-level positions to develop careers in the health innovation sector.”

campaign, the audience is young minority adults in high school and early college levels (16 to 22-year-olds). The 

campaign encourages students to visit a 

where they can learn more about careers in clinical research which can lead them to explore colleges and universities offering degrees and certificates in clinical research as well as explore ACRP’s “Getting Started in Clinical Research” 

where they can learn more about different career paths, take introductory training programs, explore internship and job postings and more. In additional to the digital advertising campaign, materials are also available for organizations to download where they can build awareness of clinical research as a career option at live or virtual job fairs.

Results from our pilot outreach to 400,000 students has resulted in over 90,000 visits to our webpage; in essence since January 2020, nearly 100,000 more students are aware of clinical research as a career option that might not ever have heard about this in the past. The pilot project has helped us to determine and refine the most appropriate messaging and media outlets to reach an even larger audience. Our campaign will be modified according to lessons we have learned as we expand to new cities, target additional ethnic and minority groups, and expand our age range to capture the attention and imagination of middle schoolers.

There are other efforts out there to be applauded and encouraged. For example, in Massachusetts, 

is helping oversee an internship program fueled by four leading life science organizations—MassBio, MassBioEd, Massachusetts Life Science Center, and Life Science Cares. The program connects passionate, high-achieving, four-year college students with paid internships of up to 12 weeks. Across the state, leading companies will collectively be reserving a minimum of 75 internship slots for Project Onramp’s new Life Sciences Scholars Program. Promoting diversity in the clinical trial workforce will have a number of benefits, says Project Onramp participant Laurie Halloran, BSN, MS, CCRA

president and CEO of Halloran Consulting Group, not the least of which will be to “bring a legitimacy to clinical research it doesn’t currently have [when] the patient population we’re studying needs to be [more] diverse,’ told ACRP in August, 2020.

Certainly the work of MRCT, provides a robust roadmap and comprehensive list of resources and practical ideas that employers of all types and sizes across the life sciences industry can implement.

It’s not going to be easy to promote diversity. It’s going to take hard work on a number of levels to reverse current trends and address systemic disparities. And it’s going to take time. Looking ahead, ACRP’s goal in 5 to 15 years is to achieve a thriving clinical trial workforce with enough people in the industry to do the research, but also a workforce that is more diverse and capable of building trust with minority populations and boosting their representation in clinical studies. This will lead to more accessible research, better data available for making clinical decisions, and improved health for minorities. We are committed to being part of the solution—how about you?

is the Workforce Innovation Officer for ACRP.

Yates, I, et. al. Representation in Clinical Trials: A Review on Reaching Underrepresented Populations in Research. Clinical Researcher. August 10, 2020. Retrieved from: 

https://acrpnet.org/2020/08/10/representation-in-clinical-trials-a-review-on-reaching-underrepresented-populations-in-research/

Pena, Y., et, al. The Critical Need for Transparency and Disclosure of Participant Diversity in Clinical Trials. Clinical Researcher. August 10, 2020. Retrieved from: 

https://acrpnet.org/2020/08/10/the-critical-need-for-transparency-and-disclosure-of-participant-diversity-in-clinical-trials/

Spinner, J. SubjectWell eyes diversity in COVID-19 vaccine trials. Outsourcing Pharma.com. August 27, 2020. Retrieved from: 

https://www.outsourcing-pharma.com/Article/2020/08/27/SubjectWell-eyes-diversity-in-COVID-19-vaccine-trials

Moderna Slows Vaccine Trial Enrollment to Ensure Minority Representation. September 4, 2020. Retrieved from: 

https://www.thestreet.com/investing/moderna-mrna-stock-coronavirus-vaccine-covid-trial-enrollment

FDA: Racial and Ethic Minorities in Clinical Trials. 

https://www.fda.gov/consumers/minority-health-and-health-equity/racial-and-ethnic-minorities-clinical-trials

MRCT Guidance Document: Achieving Diversity, Inclusion and Equity in Clinical Research. August 6, 2020. Available for downloading at: 

https://mrctcenter.org/diversity-in-clinical-trials/

ACRP Special Report: An Assessment of the Adequacy of the Clinical Research Workforce. Available for downloading at: 

https://acrpnet.org/special-report-an-assessment-of-the-adequacy-of-the-clinical-research-workforce/

ACRP Blog: Diversity Will Broaden Clinical Trial Workforce. August 17, 2020. Retrieved from: 

http://acrpnet.org/2020/08/17/diversity-will-broaden-clinical-trial-workforce/

Articles

The pandemic has thus far disproportionally impacted minority populations, and our ongoing failure to adequately represent all patients regardless of demographic background has never been more important to remedy than it is today, writes ACRP Workforce Innovation Officer Beth Harper. 

The Time is Now to Promote Clinical Trial Workforce Diversity

In the battle for the war on talent, biopharmaceutical companies, particularly those in competitive markets, are having to find creative strategies to enhance their staff recruitment, engagement and retention practices.

 In the 2018 Employee Tenure Survey conducted by the U.S. Bureau of Labor and Statistics, it was reported that the median tenure for wage and salary workers was 4.2 years and this has not changed in a decade.

The tenure is even lower in the healthcare industry clocking in at 3.5 years for the category of “health services, except hospitals.” While this may not directly correlate to roles in clinical research, it highlights the challenges that managers and organizations face when it comes to developing and retaining talent. Should companies play an active role in investing in their employees’ growth and development? What practical approaches should employees take to ensure they have a targeted plan for growing the knowledge and skills most needed to be successful in their role? What is the best way to communicate the competency expectations of employees and set them up for success, so they perform and grow in their roles and stay with the organization? And, in a large organization with multiple managers, how can consistency in the interpretation of these expected competencies be ensured? These were but a few of the questions that the clinical operations group at Genentech has tackled over the last few years. In this article we provide a case study for how we went about addressing these workforce challenges, where we are and what we learned along the way.

Genentech, a member of the Roche Group is headquartered in South San Francisco, a hotbed for high-tech and home to many biopharmaceutical companies. Roche, like many organizations, functions around a set of core competencies that outlines the cultural and organizational behaviors that are expected of all employees including such teamwork and collaboration, decision making, and innovation. These competencies include both technical (e.g. achieving results) and leadership (e.g. communication) competencies. These core competencies provide expectations for the skills, behaviors and knowledge (SBKs; sometimes also referred to as Knowledge, Skills, and Abilities—or KSAs) that employees should demonstrate and master to fulfill Roche’s overall corporate objectives.

As part of a larger initiative focused on developing, retaining and shaping our study management leaders to build the culture of tomorrow, Genentech’s early research and development (gRED ECD) clinical operations group wanted to address long-standing feedback from employees and managers on the lack of a consistent framework for mapping the Roche core competencies. Additionally, the group struggled with the lack of a standardized way of defining these competencies across all jobs and job levels.

To address these issues, gRED partnered with the Association of Clinical Research Professionals (ACRP) and embarked on a journey in 2018 to ideate and develop a solution. The “Competency Framework Initiative '' (herein referred to as “the initiative”) was started with some of these immediate needs in mind along with a recognition of the larger challenge of securing, growing, and retaining talent in a highly competitive market. 

Specifically, the goals of the initiative were to:

Provide a standardized and consistent way of tying the Roche Core Competencies to key job responsibilities across all job levels within study management

Develop a multi-purpose guidance tool for all managers and employees for:

Clinical operations managers and their direct reports to take a more targeted approach in identifing areas of strength, development, and growth (goal setting)

Clinical operations employees and managers to have a systematic and standardized way to evaluate the competencies at their existing job level and assess the talent pipeline

Provide learning “playlists” that match the descriptions defined in the core competencies to aid in easy identification of learning resources

Update job descriptions to align with the SBKs outlined in the framework

More broadly speaking, the competency framework and associated training and competency-based job descriptions were expected to be a powerful tool to empower and motivate employees to take charge of their development and use the framework to refine their development plans. In essence, the initiative was designed to help our employees identify areas of focus and to generate clarity on the competencies in each role.

The study management function within gRED consists of four different job roles ranging from an associate Clinical Trial Leader (CTL) to a senior and principal CTL. Specifically, these roles span a broad range of clinical trial leadership and technical responsibilities.

The initiative was a multi-step approach that involved the following:

Step 1: In collaboration with ACRP, a small group of managers (herein referred to as “core team”) reviewed the competency domains and developed definitionsfor theskills, behaviors and knowledge (herein referred to as SBK) requirements for each of the competency domains outlined in the Roche Core Competencies for each of the three job roles in study management. Due to the monumental nature of the task and ACRP’s experience in developing role-specific competency guidelines

, gRED contracted with ACRP to provide consultation and support throughout the project

Step 2: For thoroughness and robustness of the framework, the core team compared the technical and leadership competencies against the harmonized core competency framework developed by the Joint Task Force for Clinical Trial Competency (JTF)

and added additional technical and leadership SBK statements

Step 3: All managers participated and were engaged in a sprint workshop to review the exhaustive list of SBK in each competency domain and consolidated them into a manageable and succinct list.

Step 4: This list was translated into an easy to digest spreadsheet format

Step 5: In partnership with the Learning and Development (herein referred to as L&D) group, a small subset of managers and their direct reports (at each of the three levels of study management) piloted this framework and provided feedback

Step 6: The framework was further refined based on the feedback from the pilot attendees and finalized 

Step 7: The finalized framework was shared with managers; an FAQ was developed to aid managers in the roll-out and “office hours” held to answer any questions

Note: The framework was shared with study management via email and discussed at a forum

Step 8: Check-in meetings were held with managers to answer any questions and incorporate any feedback post launch

Figure 1. Competency Framework Development Process Steps

Updating the job descriptions to ensure that talent is hired to the same standards defined in the framework and to ensure that our job descriptions reflect the skills, behaviors and knowledge of our workforce

Developing the training “playlists” to give employees an easy access to all available learning resources

We plan on updating the defined SBKs within the framework based on feedback from managers and employees. Additionally, we recognize that this effort was unique for the industry, in terms of creating a competency framework for clinical trial leaders. ACRP plans to build upon aspects of the CTL competency framework as they expand their competency resources.

Transitioning from traditional job descriptions and performance assessment tools, to a competency-based roadmap for staff development and assessment was both challenging and rewarding for the core team. Some key take-aways from our experience include:

While some industry-standard competency guidelines exist for other clinical research professional roles (CRAs, CRCs and Investigators)

, there were very few competencies that we could incorporate into the more advanced SBKs required of a clinical trial leader

It's easy to go overboard—adding too many sub competencies can make the framework cumbersome and can lead to issues with adoption

It is very important to bring all managers along in the process; the core team continuously solicited feedback from all managers in sprint sessions along the way

It is prudent to run a small pilot to gather feedback from direct reports and managers to 

gather frequently asked questions about the framework and its implementation 

refine the defined sub competencies (e.g. delete repetitive or add missing sub competencies)

Creative approaches are needed to address the clinical research workforce “talent wars”. A business-as-usual mindset won’t solve the problems, but a competency-based approach offers many benefits to the employer as well as employee. While every organization will adopt their own approaches to developing their talent, we hope that the methodology discussed here provides some practical guidance for those embarking on a similar journey.

While innovative hiring and engagement tactics may offer a competitive advantage, making investments in our staff is just the right thing to do for the patients we are trying to serve.

We look forward to sharing updates and lessons learned as we gain further experience with this initiative.

is the Workforce Innovation Officer at the Association of Clinical Research Professionals.

Harper, B. Talent Talent Wars: How To Develop A Competent Clinical Research Workforce In A Competitive Environment. Clinical Leader. 

https://www.clinicalleader.com/doc/talent-wars-how-to-develop-a-competent-clinical-research-workforce-in-a-competitive-environment-0001

. Published December 18, 2018. Retrieved March 6, 2020.

Henderson, L. Catch (& Keep) a Rising Star: Clinical Research Talent Trends. Applied Clinical Trials. 

http://www.appliedclinicaltrialsonline.com/catch-keep-rising-star-clinical-research-talent-trends

. Published March 1, 2018. Retrieved March 6, 2020.

Bureau of Labor Statistics Employee Tenure 2018. U.S. Department of Labor. 

https://www.bls.gov/news.release/pdf/tenure.pdf

. Published September 20, 2018. Retrieved March 6, 2020.

ACRP Partners in Workforce Advancement; Define, Align and Validate Competence Standards. 

https://acrpnet.org/acrp-partners-in-workforce-advancement/acrp-partners-in-workforce-advancement-define-align-validate-competence-standards/

Joint Task Force for Clinical Trial Competency. 

https://mrctcenter.org/clinical-trial-competency/

Creative approaches are needed to address the clinical research workforce “talent wars”

A Competency-Based Approach to Combating the Talent Wars in BioPharma

Studies in “enrollment rescue mode” present dilemmas for sponsors, contract research organizations (CROs), and sites alike. While the sponsor ultimately has the most to gain or lose if a trial fails to achieve its enrollment goals, there are several ramifications to the study site that are often not considered. Sites invest a lot of time and resources to get up and running only to find that the trial is difficult to enroll or is ultimately terminated.  

	This “enrollment rescue dilemma” and how sites face these challenges is the focus for this article. Since so little is known about the impact of enrollment rescue from the site’s perspective, the authors conducted a survey to gain a better understanding of the nature and frequency of these situations. While the ultimate goal is to avoid rescue altogether, when it does occur all parties need to do things differently. This article will explore how sites tackle enrollment rescue situations, and provide some best practice considerations for how both sponsors and sites can make the most of these circumstances.

	For the purposes of this article, we define enrollment rescue as studies that are sufficiently behind in enrollment. More specifically, the particular scenario we’ll explore is the rescue study in which the enrollment target has or will be missed, resulting in more sites being added, funds being provided to sites for local tactics, and/or central media campaigns added in the hopes of reaching the enrollment goal at some point beyond the original target date.

	It’s easy to cite the often-quoted statistics from the Tufts Center for the Study of Drug Development when it comes to the percentage of sites that don’t enroll or the number of trials that are delayed from an enrollment perspective.

 Among other statistics, the 2012 Tufts CSDD study reported that 53% of studies had extended timelines, with one of six studies taking more than twice as long as originally planned. In a 2015 article about an extensive analysis of clinical trial enrollment, the authors report that (19%) of the trials analyzed either terminated for failed accrual or completed with less than 85% expected enrollment, seriously compromising their statistical power.

	From a failed enrollment perspective, there are literally over 150 root causes as to why sites don’t meet their enrollment goals.

 Broadly speaking, these can be grouped into protocol, patient, site, sponsor, or site relationship management related issues. Communication problems among stakeholders, patient enrollment delays, overly complex protocols, and poor site compliance are just a few of the many reasons why rescue action is needed.

	Based on Altura’s experience supporting recruitment for over 300 studies, recruitment planning tends to focus on asking sites how much they can enroll during the site selection process. This site estimate on the internal potential subjects is coupled with external supply estimates typically from sources such as central media campaigns and/or pass through local recruitment funds. This process frequently leads to an overestimation of enrollment potential, resulting in an increased probability of a future rescue scenario.

	Even with the best intentions and a committed study team, sites are over worked and understaffed, as highlighted in the findings from a recent industry survey.

 This further compounds the challenges that even the most well-intentioned sites face.

	Consider what typically happens in the enrollment rescue scenario. The sponsor or CRO usually undertakes the same site feasibility, qualification, and selection process for add-on sites that they followed initially and/or they decide to add central or local tactics and resources. If sponsors don’t adapt their approach, they may still end up with non-performing sites.

	Adding incremental resources for current sites can also be a challenge, as most sites may be experiencing study fatigue. If new tactics are brought in (including local or central), then vendor additions or integration can also be a challenge for sites. Increased volume of patients that do not meet criteria can further increase a site’s study fatigue and exhaust their limited resources on unfruitful efforts.

	From the site perspective, if the new sites aren’t judicious about evaluating rescue situations, they may not be successful, thus putting their reputations at risk. If a site fails to enroll ample subjects, then they can’t leverage study startup costs (e.g., preparation and training for investigators and study staff) and may be financially worse off as well.

	How discriminating the new sites are when evaluating these studies, what they ask for, and what influences their decision are among the topics explored in a survey the authors undertook to better understand how sponsors, CROs, and sites alike can maximize these situations.

	Research sites from various specialties within the U.S. and Canada were identified via a database of sites with whom Altura has worked over the past 15 years. Since its inception in 2000, Altura’s mission is to expand study participation by involving more patients, healthcare providers (HCPs), and health systems via its Study Engagement Platform™, which includes HIPAA-confirming technology such as its HCP Studies™ mobile app/portal. A total of 323 sites responded to an online survey in the fall of 2016 to determine enrollment rescue insights and experiences.

	To gain an understanding of how frequently sites are faced with evaluating rescue study opportunities, sites were asked to indicate their total number of study starts per year along with their estimates of the percentage of those that are rescue situations. On average, the majority of respondents start one to 10 trials a year (Figure 1).

	Of these trials, on average, less than 10% of the trials the sites contract with are rescue studies. This roughly translates to about one rescue trial that the survey respondents take on each year (Figure 2).

	Interestingly, for the most part, when the sites are approached about a rescue opportunity, they typically sign on for the trial (Figure 3). This may reflect a general phenomenon for sites overall; they optimistically accept all trials regardless of whether issues about enrollment or other challenges are known upfront or not. The psychology of sites accepting protocols and sponsors/CROs accepting sites for which they are not well suited likely contributes to the chronic problem of rescue studies in the industry and warrants further exploration.

	On the other hand, the survey results revealed that sites are not always made aware, up front, that a study is in rescue mode (Figure 4). Not being aware of the situation can certainly impact the site’s enrollment performance, so it behooves all parties to thoroughly assess the situation before making a commitment to participate.

	When sites are made aware that a study is in rescue, they report a myriad of variables that they assess before making the decision to accept the trial. The availability of the patient population and ability to successfully enroll was by far the primary factor sites considered when taking on a rescue project (Figure 5).

	The majority of the survey respondents noted that they are only sometimes made aware of the specifics, with about 20% reporting that they are rarely or never made aware of the details (Figure 6). Whether this is an obligation of the sponsor to reveal this, or the site to demand this information, may be a matter of debate. Nonetheless, without a detailed understanding of the factors leading to poor enrollment, the add-on sites are at risk for performing the same or worse than the existing sites.

	Regardless of how much information about the enrollment challenges is received or revealed, the survey respondents noted that they only receive additional support in about 25% of the cases. The majority of time the sites report receiving only the same level of support from the sponsor/CRO, as in a non-rescue situation (Figure 7). Sponsors and CROs may be missing a golden opportunity to set the add-on sites up for maximum enrollment success. Above and beyond this, it’s also critical to address the needs of the current sites who may need some support, without abandoning them altogether in favor of adding on additional sites.

	The vast majority of respondents indicate that their enrollment in these trials, sometimes exceeds enrollment in the non-rescue situation, with about 20% of the sites indicating their performance rarely or never exceeds that of the non-rescue situation (Figure 8). It should also be noted, however, that the target is frequently lowered for rescue sites, which makes it easier to achieve the enrollment goal. Furthermore, protocol amendments may make entry criteria a bit easier in many of the rescue situations as well.

	Whether additional support would have a significant impact on the site’s enrollment performance may be difficult to quantify; however, intuitively, it makes sense that helping the add-on sites would lead to even better performance. The same would apply to current sites. When asked about the type of support that would promote a more successful collaboration in rescue situations, sites reported a number of areas where they feel sponsors and CROs could be more helpful (Figure 9). Not surprisingly, being transparent about and addressing all of the root cause issues contributing to the rescue situation ranked highest in terms of ensuring success in these situations.

	Based on self-reported results, the majority of sites who take on rescue studies have some success in enrolling for them; however, they may be even more successful with some additional transparency and support. The right type and amount of support for current sites would also be beneficial. Most sites want to understand the challenges ahead of them through full disclosure about the successes, study issues, and timeline constraints. Sponsors and CROs could improve in these areas, as only 41% of the surveyed sites are always or very often made aware that a trial is in a rescue situation when first approached by a sponsor or CRO. Furthermore, sites report that sponsors provide detailed information about why the study is behind in enrollment very often or always only about 40% of the time.

	 With the pressure of finding patients in a shorter timeline in rescue studies, sponsors need to recognize that sites need and will benefit from more support, particularly in the area of recruitment support. With the majority of the sites (~70%) reporting they received about the same level or less support from the sponsor or CRO when working under a rescue situation as compared to a non-rescue study, this presents a major opportunity for improvement.

	Adding more sites can be a solution, but the sunk cost with existing sites is significant. Since enrollment at sites tends to be serendipitous, it behooves sponsors to identify sites that have strong potential but just do not have the tools and time to focus on enhanced recruitment, especially for studies with stringent entry criteria where a wider but focused net must be cast. Examples of tactics for current sites, and new rescue sites, include:

		Gain access to site and site-related electronic medical records (EMRs) and databases to validate true enrollment potential and drive efficient patient prescreening.

		Gain access to HCPs that are in the care continuum for the desired population and ensure they have easy access to the study and patient transfer process.

		Ensure all central and local media leads have been reconciled and processed.

	Sites share an equal responsibility for ensuring a successful collaboration in rescue situations. Some specific best practices and questions the sites should consider include the following:

		Compare the study’s challenges with your site’s experience in similar trials. Is your site going to be able to overcome what is a challenge for other sites?

		How will the site find the patient (e.g., databases, provider referrals, principal investigators practice patients as they present, media)?  

		What are the studies top three prescreen disqualifiers and screen fail reasons? How does this impact your patient pool?

		If you aren’t able to recruit from your known patient population or a well-established referral base, how much and what type of recruitment support (e.g., budget, recruitment service provider) will be available to help you reach the target population?

		Have you taken studies like this in the past? Did you succeed in meeting your goal? If not, how will this study be different?

		From a budget and contractual standpoint, are there any obvious issues that will preclude you from a rapid start-up? Will the budget cover your start-up expenses and efforts in the event enrollment is met or the trial is terminated before you actually get initiated?

		Do you have the staff and resources to dedicate to the trial and are they willing and able to work within the additional pressure inherent in a rescue situation?

		Logistically, can you conduct the study visits and procedures with the space, time, and staff that you have?

		Are any of the inclusion/exclusion criteria ambiguous and/or subject to interpretation? If so, clarify your position with the sponsor to ensure alignment.

		Have protocol amendments occurred or will they occur? What’s the anticipated impact?

		If central or local media will be implemented, what type of support will be provided to ensure site burden is minimized.

	While rescue situations may be an inevitable fact of life for the clinical trials industry, the results of this survey highlight important and actionable insights that sponsors, CROs, and sites should consider when faced with enrollment challenges. It’s important not to assume all current sites can’t increase enrollment with the appropriate resources and support. At the same time, it might be time to close many current sites if indeed they have no additional potential to enroll. For add-on sites, being forthright about the fact a trial is in rescue, sharing as much information about the causative factors and what’s being done to address these can all have a significant impact on ultimately achieving the enrollment goals. The fact is that all study stakeholders share an important role in ensuring enrollment rescue success.

 is President of Clinical Performance Partners, Inc.; email: bharper@clinicalperformancepartners.com

	1. Getz, K. Enrollment Performance: Weighing the "Facts." 

http://www.appliedclinicaltrialsonline.com/enrollment-performance-weighing-facts

	2. Carlisle, B. et al. Unsuccessful trial accrual and human subject protections: an empirical analysis of recently closed trials. 

https://www.ncbi.nlm.nih.gov/pubmed/25475878

	3. Source: Clinical Performance Partners, Inc. 2010

	4. Source: GoBalto. Better Study Startup Means Less Rescue. 

https://www.gobalto.com/blog/better-study-startup-means-less-study-rescue

	5. Source: CenterWatch-ACRP Career and Salary Survey 2015; N=2,508

Survey uncovers key best practices that sponsors, CROs, and sites should consider when faced with patient enrollment challenges. 

The Enrollment Rescue Dilemma: How Sponsors and Sites Can Make the Most of a Tough Situation

	Even with the best intentions and a committed study team, sites are over worked and understaffed, as highlighted in the findings from a recent industry survey (see Table 1).


	The majority of the survey respondents noted that they are only sometimes made aware of the specifics, with about 20% reporting that they are rarely or never made aware of the details (Figure 6). Whether this is an obligation of the sponsor to reveal this, or the site to demand this information, may be a matter of debate. Nonetheless, without a detailed understanding of the factors leading to poor enrollment, the add-on sites are at risk for performing the same or worse than the existing sites.

	Based on self-reported results, the majority of sites who take on rescue studies have some success in enrolling for them; however, they may be even more successful with some additional transparency and support. The right type and amount of support for current sites would also be beneficial. Most sites want to understand the challenges ahead of them through full disclosure about the successes, study issues, and timeline constraints. Sponsors and CROs could improve in these areas, as only 41% of the surveyed sites are always or very often made aware that a trial is in a rescue situation when first approached by a sponsor or CRO. Furthermore, sites report that sponsors provide detailed 

information about why the study is behind in enrollment very often or always only about 40% of the time.

	With the pressure of finding patients in a shorter timeline in rescue studies, sponsors need to recognize that sites need and will benefit from more support, particularly in the area of recruitment support. With the majority of the sites (~70%) reporting they received about the same level or less support from the sponsor or CRO when working under a rescue situation as compared to a non-rescue study, this presents a major opportunity for improvement.

 is President and CEO of Altura; email: 

 is President of Clinical Performance Partners, Inc.; email: 

Beth Harper

Articles

The Time is Now to Promote Clinical Trial Workforce Diversity

A Competency-Based Approach to Combating the Talent Wars in BioPharma

The Enrollment Rescue Dilemma: How Sponsors and Sites Can Make the Most of a Tough Situation

Making the Most Out of Enrollment Rescue Dilemmas