Daniella McCrorie

Clinical research is integral to the advancement of medical knowledge and health support services. Successful clinical trials are dependent upon a number of factors; however, none may be more important than understanding the wants and needs of those intimately involved in trial implementation. Site staff, including principal investigators (PIs) and study coordinators (SCs), must dedicate a significant amount of time, energy, and resources to ensure trial success, and overall staffing requirements are one of the most expensive aspects of a clinical research program.

 Study nurses, for example, contribute greater than 30% of their overall time to any given clinical trial.

 Moreover, physicians act as a primary resource for those seeking health-related information; a survey examining health-related decisions and clinical trial participation found that participating in a study was directly associated with the level of physician involvement.

	Given the important role of site staff for overall trial success, it is critical to understand preferences and experiences related to learning, communication, and support when conducting a clinical trial. These insights are invaluable when it comes to shaping future sponsor-driven support, engagement plans, and training initiatives for enhanced trial success.

	In order to assess site staff perspectives, an online survey was developed assessing three areas of clinical trial implementation: training preferences, communication with sponsors, and recruitment and retention initiatives. The survey was developed using SurveyMonkey and the link was distributed via email to 85 site staff across the U.S. In total, 38 site staff completed the survey, including 28 (74%) SCs and seven (18%) study nurses. Three respondents selected 

 (8%), and identified themselves as either site director (n=1) or site manager (n=2). On average, the majority of respondents indicated a high level of experience managing clinical trials, with 74% managing ≥7 clinical trials, 18% managing 4-6, and 8% managing 1-3 at any given time.

	Site staff were first asked general questions regarding overall preferences in terms of site initiation visits (SIVs) and monitoring. The majority of respondents indicated that they preferred on-site (84%) compared to remote (16%) SIVs and that lasted either one to two hours (58%) or a half-day (34%) was the preferred length of time for completion. Only a small number of site staff preferred 30 minutes (3%) or one day (3%). When asked what should be covered during a SIV, protocol-specific training emerged as the main request, including time spent on any unique study-specific factors that may affect a site’s ability to successfully manage the trial. Other study procedures, such as labs, schedule of assessments, and source documents were also identified as important aspects of a SIV.

	In terms of on-site versus remote monitoring, the majority of respondents indicated that they preferred on-site monitoring (92%) compared to remote (8%). This preference may be due to the fact that a large percentage of site staff felt that remote monitoring increased site budget costs (58%). This finding is interesting, given the recommendation from the FDA encouraging an increase in remote monitoring in place of on-site.

 With the increase in electronic systems and records, as well as improvements in statistical assessments, remote monitoring can improve the quality and efficiency of sponsor oversight of clinical investigations.

 With this in mind, the FDA is also recommending a risk-based approach to monitoring, which involves identifying the most critical data elements and processes necessary to achieve study objectives and developing a corresponding monitoring plan.

 Not only is risk-based monitoring associated with improved data quality and quality oversights,

 it also has the potential to cut down on the costly practice of on-site 100% source data verification.

 The FDA indicates that results of risk-based assessments usually involve a combination of both on-site and remote options, dependent upon each site’s specific requirements. Given results from the present study indicating site staff’s preference for on-site monitoring, in combination with the FDAs recommendation for increased remote monitoring, a risk management approach might be the best way for sponsor’s to find an ideal monitoring strategy suitable for each site.

	From the initial phases of trial set-up and protocol review to the final stages of patient retention, training should be made available to all staff, ensuring that it is tailored to their role and position and also in accordance with Good Clinical Practice guidelines.

 Moreover, training should be offered via a number of formats to ensure that various learning styles are considered; therefore, understanding site staff preferences can help sponsors to develop a tailored training program. With this in mind, site staff were asked to rank preferred platforms to receive sponsor-driven training related to clinical trials (1 = least preferred to 4 = most preferred). As shown in Figure 1 below, respondents indicated a preference for face-to-face meetings, followed by self-directed online education modules, WebEx/teleconferences, and, lastly, paper materials.

	Site staff were asked to rate a number of items in terms of their importance and contribution to successful face-to-face meetings. Presentation delivery and content were rated as the most important, followed closely by opportunity for feedback, location/facilities, interaction/best practice sharing, and accommodations and food/beverages. In terms of preferred method of delivery/session design at face-to-face meetings, site staff indicated that they most preferred plenary sessions, followed by panel discussions/Q&A sessions, interactive workshops/break-out groups, and interview style sessions. When asked further about preferences for interactive workshops/break-out sessions, site staff were split in terms of those who preferred to be grouped with colleagues from different sites (55%), versus those who preferred to be grouped with colleagues from their own site (45%). An important aspect of face-to-face meetings that was mentioned by many respondents was the opportunity for practical, hands-on experiences. This included break-out sessions to discuss recruitment and hands-on learning to become more familiar with the daily logistics of running the study.

	Another important aspect of face-to-face meetings is the incorporation of additional value-add topics (e.g., effective communication, recruitment action planning), which can contribute to the overall success of a meeting if properly executed. Site staff were asked what value-add topics they would be interested in learning more about. Some common responses included:

		Lessons learned from similar trials/success stories

		Professional development (e.g., conflict resolution, prioritizing, goal-setting)

		Study coordinator session-specific training

	Finally, site staff were asked to share considerations that would support increased attendance at face-to-face meetings. A number of themes emerged:

		Have meetings adjacent to a weekend (either beginning or end of week); some preference for weekends, depending on clinic hours

	In this digital era, it is no surprise that iPads have been introduced during face-to-face

 meetings as a way to increase audience engagement and interaction. According to site staff, 29% indicated that >75% of meetings attended incorporated iPads (refer to Figure 2 at right for additional details). When asked if iPads significantly increased the overall quality of a meeting, 45% indicated 

	In terms of overall face-to-face training preferences, plenary sessions were rated as the most preferred method of session design and both presentation delivery and content were rated as the most important considerations for a successful meeting. With this in mind, sponsors should consider the importance of pre-meeting speaker training and rehearsals, as well as overall presentation formatting. Speaker training can help to ensure that key messages are embedded throughout all presentations and that the content flow, alignment, and overall delivery is consistent and positive across all speakers. Additionally, professional formatting of slides is important to ensure that all presentations are visually appealing; address key messages with minimal text; and incorporate interactive elements as much as possible.

	As mentioned earlier, iPads are increasingly being incorporated during meetings and can be an excellent tool to increase site staff engagement and participation, especially for those participants whose first language is not being spoken at the meeting. For example, polling questions can be used to gauge audience comprehension of key learning objectives; games, such as a play on 

 can be incorporated into appropriate sessions to add a level of friendly competition; panel discussions can be enhanced by allowing participants to submit questions via iPads; lastly, both note-taking and allowing participants to view presentations on their iPads are helpful tools to support knowledge retention and understanding. It is important to remember that when incorporating iPads, the focus should be on how to use them as a complementary tool, not a distraction.

	With a vast range of technology now available to support convenience and working remotely, online education is becoming more popular as an alternative or complementary training option. Site staff were asked to answer a number of questions regarding their preferences and experiences with this type of training platform. In terms of maximum length of time considered reasonable to spend per online training module, site staff preferred 20-30 minutes (47%), followed by 30-60 minutes (32%) and 10-20 minutes (21%).

	Although online education offers convenience and consistency, individuals need to be motivated to complete such programs as it is centred on self-paced learning. Therefore, in order to increase the likelihood of site staff completion, it is important to understand their underlying motivation. When asked to rank the greatest motivator to complete an online education program, site staff indicated that having the training be mandatory was the most motivating factor, followed by: the need to know the information to complete the trial, receiving a certificate of completion, and self-interest in the topic.

	When asked how likely they would be to complete an online education module that was not mandatory, the majority of respondents indicated 

 (16%). Lastly, site staff were asked whether they believed that an online education program was sufficient as a standalone training initiative for clinical trials; the majority of respondents indicated 

 (79%). When asked what combination/type of training is preferred to online only, the majority of respondents once again confirmed the importance of face-to-face meetings. Specifically, site staff indicated a preference for investigator meetings or additional onsite training, indicating that both of these platforms offer greater opportunity for understanding via live question and answer periods.

	Therefore, online education programs should not be the only source of training and should be combined with more traditional face-to-face meetings for maximum impact. Sponsors should consider rolling out online training as a first approach, allowing future investigator meetings to be tailored based on online quiz responses. Although face-to-face meetings were identified as the most preferred method of training delivery, online education can offer a number of advantages and should not be overlooked. For instance, online training modules:

		May be completed at one’s convenience

		Offer consistent messaging, especially for global trials

		May be easily updated as required with timely roll-out

		Confirm knowledge retention as well as areas of strength and improvement via quiz questions

		Complement face-to-face training as pre- and/or post-meeting work

	In order to ensure completion, online training modules should be as interactive as possible, focusing on key information necessary to manage the trial. In addition, sponsors may wish to consider providing some sort of personal incentive (e.g., certificates of completion) or friendly competition via gamification.

	Another important aspect of overall clinical trial success is the frequency and format of sponsor-driven communication. Site staff were asked to rank how they prefer sponsors to deliver trial-related information. The most preferred method was email, followed by newsletters, web conferences, telephone calls, face-to-face site visits, and Skype. When asked to indicate how often site staff prefer sponsor contact during the course of a trial, the majority indicated 

	One of the most common struggles with any clinical trial is patient recruitment and retention. In terms of recruitment, site staff were asked to indicate the importance/usefulness of a number of strategies (1 = not useful at all to 5 = extremely useful). In order of importance, site staff indicated Clinic database, Hospital database, Traditional advertising, Referral network, and Online strategies (see Figure 3). 

	Of those who indicated “Other,” responses included:

		Listing of open studies on site’s public website

		Hire a dedicated recruitment person (other than study coordinator)

	Recruitment materials are often provided by sponsors and can be effective tools to help sites communicate complex trial designs and procedures in a manner that is friendly and appropriate to the general public. However, they can also be very expensive to produce for use in multiple countries and languages; therefore, it is important to understand which materials site staff actually use and find helpful. Site staff were asked to rate the helpfulness of a number of both site-facing and patient-facing recruitment and retention tools. In terms of site-facing materials, staff rated the following items from most helpful to least helpful: mini, tabbed protocols; reference cards; referral letters; and online community/networks (see Figure 4). 

	Site staff were also asked to rate the helpfulness of a number of patient-facing recruitment and retention tools (see Figure 5 below). The most helpful item, according to site staff, was the “welcome” tote bag. As patients are provided with a great deal of information and materials related to their participation in a trial, welcome tote bags provide a convenient solution to hold these items, especially when patients are required to bring items to and from site visits on an ongoing basis throughout the duration of the trial. Most often they include a welcome letter, study participation guidebook with schedule of assessments, extra appointment cards, a patient ID card that can be provided to other healthcare providers, activity books (e.g., coloring books and crosswords for a pediatric population), patient diaries, and patient reported outcomes.

	Interestingly, informed consent videos were rated as the least helpful in terms of patient-facing recruitment and retention tools. The informed consent process can be very daunting for patients, and, therefore, needs to be addressed in simple, easy-to-understand language. While informed consent videos may be appropriate for some trials (e.g., pediatric trials), sponsors should seriously consider their patient’s level of understanding prior to developing an informed consent video, as these can be very time consuming and costly. 

	Site staff were also asked to provide other recruitment or retention resources that they have found useful:

		Diabetic socks, water bottles, and pedometers

		Patient education materials, cook books, reference guides, diabetic supplies, smartphone apps

		Language-specific documents (advertisements, informed consent form, etc.)

Articles

Survey drills down on the preferences and experiences of clinical trial site personnel in critical function areas such as site initiation and monitoring, training, sponsor interaction, and patient recruitment and retention.

Daniella McCrorie

Articles

Enhanced Site Training, Resources, and Communication