DSAT Methodology

Design

A cross-sectional design was used to collect data from a diverse set of site representatives via an online administered survey.

Sample

Several databases were tapped into invite participation in the study. These included members of the SCRS, LinkedIn and other social media contacts. It is estimated that an approximate total of 17,000 representatives from clinical trial sites were invited to participate in the study via a link to the survey used to collect the data. 

Data collection

Over a period of three months, each participant was able to click on a link to a survey that was available to them. The survey consisted of the DSAT and a section on demographics about the participant and their site. The DSAT is composed of 25 items each of which are anchored to a 6-point scale (0-No opportunity to Observe, 1-"Hardly ever (<or =5% of the time)", 2 - “Rarely (6-24% of the time), 3 - “Sometimes (25-49% of the time), 4 - “Often (50-74% of the time), 5 -“Nearly Always (75-94% of the time) and 6 - "Always (95% or more of the time) ). The 25 items are part of three sections: 1) Site Overview (10 items), 2) Site Recruitment and Outreach (9 items) and 3) Patient Focused Services (6 items). For this paper, frequencies, and percentage (%) of responses for Nearly Always and Always were merged to identify areas of improvement in diversity recruitment. To be able to discuss areas of improvement for the entire clinical site research industry, descriptive analysis was conducted for all respondents and then subgroup analysis was conducted. Based on the assumption that opportunities for improvement vary by the type of site and the number of studies conducted, during the subgroup analysis, we cross tabulated the type of practice that the respondent represented, and the self-reported number of studies conducted within that type of practice. While each of the resultant data is presented in tabular form, in the results section below opportunities for improvement are only summarized where 10 or more responses were tabulated in the subgroup. 

Results: Tables 1-6 presents the results of our analysis. Based on these results, the following opportunities for improvement are identified:

1. For Clinical Trials Industry as a whole: Table 1 provides an insight into the opportunities for improvement for the whole industry based on the responses received from all participants. Based on low frequencies for how often (always and nearly always) the best practices are observed, the top five areas where opportunities to improve exist are: a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) Conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.), c) If allowed by state/local regulations, accommodating working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits, d) Offering phone prompt for most frequently used languages (i.e., press 1 for Spanish) and e) When needed, making provisions for providing a place to stay for patients and their family members including children.
2. For Private Practice that Conducts Clinical Trials: Table 2 details the responses aggregated for individuals who reported working for private practice that conduct clinical trials, majority of whom reported conducting up to 10 studies per year. For members of this type of practice, the top five opportunities to improve are: a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) Conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.), c) When needed, utilizing appropriate media outlets (radio, TV, social media) specific to the targeted population, d) Offering phone prompt for most frequently used languages (i.e., press 1 for Spanish) and e) When needed, making provisions for providing a place to stay for patients and their family members including children.
3. For Research Company in a Hospital or Physician Office: Table 3 showcases results for respondents who reported working for a research company in a hospital or physician office, majority of whom reported conducting up to 10 studies per year. Within this practice, the top five opportunities to improve are: a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) Conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.), c) If allowed by state/local regulations, accommodating working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits, d) Offering phone prompt for most frequently used languages (i.e., press 1 for Spanish) and e) When needed, making provisions for providing a place to stay for patients and their family members including children.
4. For Research Institutions (e.g. Academic Medical Centers): Table 4 presents results for respondents who reported working for a research institution. Interestingly, predominantly respondents were working for either a research institution that conducted less than 5 studies (referred to below as Small RIs) or were working for a research institution that conducted more than 25 studies (referred to below as Big RIs). The common areas where both these types of research institutions could improve are: a) When needed, conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.) and b) When needed, making provisions for providing a place to stay for patients and their family members including children. In addition to these, Small RIs could improve in the areas of: a) ensuring Investigator, Study Coordinator, and/or support staff are culturally representative of the patient population, b) When needed, utilizing appropriate media outlets (radio, TV, social media) specific to the targeted population, and c) Offering phone prompt for most frequently used languages (i.e., press 1 for Spanish). Whereas Big RIs could improve in the areas of: a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) Routinely requesting materials (e.g., ICF, patient recruitment materials, patient outcomes assessments, E-diaries) in languages predominantly used by members of their patient population, and c) Providing transportation services or requests reimbursement from sponsor as needed
5. For Research Departments (RDs) in a Hospital, Owned by Hospitals: Table 5 provides insight into responses from respondents working in research departments in a hospital, owned by hospitals. Predominantly respondents were working for either a research department that conducted 5- 10 studies (referred to below as Small RDs) or were working for a research department that conducted more than 25 studies (referred to below as Big RDs). The common areas where both these types of research departments could improve are: a) When needed, conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.) and b) When needed, making provisions for providing a place to stay for patients and their family members including children. In addition to these, Small RDs could improve in the areas of: a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) If allowed by state/local regulations, accommodating working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits, and c) Offering and distributing stipends in a timely manner and method easy for patient use. Whereas Big RDs could improve in the areas of: a) Creating target patient population specific retention plans, b) When needed, utilizing appropriate media outlets (radio, TV, social media) specific to the targeted population and c) Ensuring Informed Consent form is available, pre-translated and pre-IRB approved in relevant languages.
6. For Freestanding Research Centers: Table 6 provides insight into responses from respondents working in freestanding research centers. This type of practice had the highest and most diverse response and the analysis indicated that opportunities for improvement varied for the subgroups based on the number of studies conducted. The common areas where all freestanding research centers could improve include: a) Offering phone prompt for most frequently used languages (i.e., press 1 for Spanish) and b) When needed, making provisions for providing a place to stay for patients and their family members including children. For freestanding research centers that conducted less than 5 studies (referred to as very small), the opportunities for improvement were in the area of : a) When needed, site partnering with sponsor to create study-specific ,target patient population specific recruitment plans, b) Creating target patient population specific retention plans, and c) If allowed by state/local regulations, accommodating working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits. For freestanding research centers that conducted 5-10 studies (referred to as small), the opportunities for improvement were in the area of : a) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, b) When needed, conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.) and c) When needed, utilizing appropriate media outlets (radio, TV, social media) specific to the targeted population. For freestanding research centers that conducted 11-16 studies (referred to as Mid-size 11-16), the opportunities for improvement were in the area of : a) Ensuring Investigator, Study Coordinator, and/or support staff are culturally representative of the patient population, b) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, and c) When needed, conducting outreach to minority-based organizations to establish a network of referrals (e.g., churches, community centers, food banks, medical community, patient advocacy and support groups, etc.). For freestanding research centers that conducted 17-20 (referred to as Mid-size 17-20), the opportunities for improvement were in the area of : a) a tailored strategy to approach targeted populations for clinical trials, b) Creating target patient population specific retention plans and c) If allowed by state/local regulations, accommodating working patients by offering hours of operation outside of normal business hours (i.e., early arrivals and/or after hours appointments) and weekend visits. For freestanding research centers that conducted more than 25 studies (referred to as Big), the opportunities for improvement were in the area of : a) Ensuring Investigator, Study Coordinator, and/or support staff are culturally representative of the patient population, b) Tracking progress toward established diversity goals and knowing what marketing or outreach strategies works to make them successful, and c) Ensuring Informed Consent form is available, pre-translated and pre-IRB approved in relevant languages.

Table 1. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT Survey Completion All Types of Sites

Table 2. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT for Private Practice that also conducts trials

Table 3. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT For Research Company in a Physician Office Building or Hospital

Table 4. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT For Research Institutions (e.g., academic center)

Table 5. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT For Research Departments in a Hospital, Owned By a Hospital

Table 6. Identifying Opportunities for Improvement in Diversity Recruitment Based on DSAT For Freestanding Research Centers