Enhanced Site Training, Resources, and Communication

March 2, 2016
Daniella McCrorie

,
Ruth Cannata

,
Jennifer M. Eastabrook

,
Shawn Patterson Baker

Applied Clinical Trials

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.

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.1 Study nurses, for example, contribute greater than 30% of their overall time to any given clinical trial.2 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.3

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 Other (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 initiation visits and monitoring

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.4 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.4 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.4 Not only is risk-based monitoring associated with improved data quality and quality oversights,4 it also has the potential to cut down on the costly practice of on-site 100% source data verification.5 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.

 

Training preferences

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.6 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:

  • Challenges and best practices

  • Lessons learned from similar trials/success stories

  • Hands-on/practical learning

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

  • Organizational skills

  • 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:

  • Advanced notice (as early as possible)

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

  • No mid-week meetings

  • Direct flights, easily accessible

  • 1-day meeting, 2-day maximum

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 Somewhat, 29% said Yes, 21% said Not applicable, and 5% indicated No, not at all.

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 Jeopardy, 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 Somewhat likely (66%), followed by Not at all likely (18%), and Very likely (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 No (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.

 

 

Communication with sponsors

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 Monthly (70%), followed by Bi-monthly (14%), Bi-weekly (11%), and Weekly (5%).

 

Recruitment and retention initiatives

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

  • National recruitment companies

  • Central Ad

  • Physician involvement/engagement

  • 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

  • Gift cards

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

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

  • Newspaper ads, TV ads

  • Keeping in touch with patients between visits

  • Women and heart disease, restaurant calorie guide

  • Trial umbrella

In addition to the above mentioned items, patient advocacy groups can also be very helpful when it comes to recruitment efforts. Site staff were asked to rate how beneficial they believed patient advocacy groups were to increase recruitment efforts. A little over half indicated Somewhat beneficial (53%), while 30% indicated Not at all beneficial and 17% indicated Very beneficial.

In terms of recruitment barriers, site staff were asked to select their top three barriers to recruiting patients based on their individual experience. As seen in Figure 6 below, patient/family member concerns was selected as one of the top barriers more frequently than any of the other items. This could result from a number of concerns including: fear of being in a clinical trial, lack of knowledge/understanding, lack of family support, fear of study drug (e.g., injections), or lack of communication.

The latter barrier, in particular, points to the importance of doctor-patient communication. For example, the importance of using laymen terms, providing complex information in a manner that is friendly and appropriate to the general public, and connecting with potential patients on more than just a superficial level (e.g., making each patient feel like a VIP). These types of “soft-skills” cannot be overlooked in terms of importance to clinical trial success, and should be included in overall training initiatives.

 

The second-most frequently selected recruitment barrier was targeting a specific patient population. To further understand challenging patient populations, site staff were asked to indicate the patient population that they have found to be the most challenging to recruit:

  • African American and Somalian patients

  • Patients with acute coronary syndrome and ST-elevation myocardial infarction

  • Protocol specifics, such as tight laboratory parameters that target very specific patients (e.g., GFR >15<59)

  • Pediatrics

  • Elderly

  • Certain criteria within a population (e.g., cardiac population, subset certain rhythm or lab value AND on a certain medication)

  • Smokers tend to be non-compliant

  • […] multiple system disease process (e.g., patients with CAD and diabetes and kidney disease)

With this in mind, sponsors should be prepared to offer extra support to site staff when dealing with these patient populations.

  • Of those respondents who selected Other, barriers included:

  • Protocol amendments

  • Distance to research site and lack of compensation

  •  Lack of appropriate details surrounding study (in order to select the “right” trials for their site)

  • Travel/snowbirds

  • Lack of support from hospital or clinic administration

  • Eligibility requirements too strict

Lastly, site staff were asked to consider a trial that is frequently top of mind and how it differs from other trials they are involved with (e.g., services or experiences offered). Responses included:

  • On-site assistance with training of site staff

  • Phone calls every two weeks to provide study updates/daily emails to provide recruitment updates

  • Use of laptops for real-time data entry (e.g., enter information when with patient)

  • Provision of a recruitment company that provides advertising for the site

  • Paperless study (e.g., sponsor provided laptops)

  • Easily reached study personnel

  • Supportive staff/easily accessible for questions and answers

  • CRA’s from the sponsor (not from a CRO)

  • Compensation (appropriate and on-time)

 

Summary

This paper provides a detailed account of site staff preferences in terms of training opportunities, sponsor communication, and recruitment and retention initiatives during the course of a clinical trial. Sponsors need to be aware of site staff preferences and remember that each trial is unique; therefore, what works for one trial may not work for another, just as what works for one site may not work for another. By better understanding the wants and needs of site staff, sponsor-driven support and training can be tailored for enhanced trial success.
 

 

Jennifer M. Eastabrook is Scientific Advisor, AXON Clinical Trial Services; Daniella McCrorie is Director of Digital Health, AXON Clinical Trial Services; Shawn Patterson Baker is Vice President, AXON Clinical Trial Services; Ruth Cannata is Project and Site Management, C5 Research

 

References

1. Baer A, Zon R, Devine S, et al. 2011. “The clinical research team,” J of Oncol Practice, 7:188-92.

2. Emanuel E, Schnipper L, Kamin D, et al. 2009. “Costs of conducting clinical research,” J Clin Oncol, 21:4145–4150.

3. Comis RL, Miller JD, Colaizzi DD, et al. 2009. “Physician-related factors involved in patient decisions to enroll onto cancer clinical trials,” J of Oncol Practice, 5:50-6.

4. Guidance for Industry: Oversight of clinical investigations - A risk-based approach to monitoring. Food and Drug Administration. August 2013. Available at: http://www.fda.gov/downloads/Drugs/Guidances/UCM269919.pdf. Accessed May 7, 2015.

5. Sullivan LB. 2015. “The Current status of risk-based monitoring,” Applied Clinical Trials, available at: http://www.appliedclinicaltrialsonline.com/current-status-risk-based-monitoring. Accessed May 7, 2015.

6. Baer A, Cohen G, Smith DA, et al. 2010. “Implementing clinical trials: A review of the attributes of exemplary clinical trial sites,” J of Oncol Practice, 6:328-30. 

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