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Location, Location, Location

Enrolment success depends on a clinical trial sponsor’s understanding that patient recruitment and retention strategies are only as effective as the clinical sites commissioned to implement the plans. By aggressively educating and engaging sites, sponsors can mitigate competitive challenges, maintain a statistical advantage and realise enrolment success.

In order to achieve this, it is important to identify high-performing sites that are equipped to execute programme plans, train clinical staff in recruitment fundamentals, and to motivate sites throughout the enrolment process.Yet, before any of these steps can occur, the trial sponsor must be fully educated about, invested in and committed to the strategy. Afterall, though there is shared responsibility for execution, the onus of the outcome rests squarely with the sponsor as the programme progenitor and enforcer.

Securing site commitment to patient recruitment strategies requires insight into the site’s motivations and challenges.To that end, surveys were recently conducted among sites participating in 10 different clinical research studies encompassing four continents and 37 countries. Of 384 respondents, 58 per cent were nurses and clinical research coordinators, while 42 per cent were principal investigators.A striking 78.2 per cent of survey participants reported that their sites had failed to meet patient enrolment goals.This feedback aligns with a November 2010 CenterWatch report which underscored that half of all sites under-enrol or fail to enrol a single patient, while 30 per cent of sites provide 70 per cent of all evaluable subjects. Consequences for sites that perform poorly run the gamut up to and including closure.

Research shows that that the chief impediments to patient enrolment from a site’s perspective include: insufficient volume of patients at the practice level who meet study criteria; a lack of study awareness among potential referring physicians; and an absence of study awareness materials targeted to patients.

Despite these challenges, some sites may fail to fully follow sponsor-approved patient recruitment programmes.As a case in point, in regions where these strategies are permissible, less than half of survey respondents reported use of direct-topatient advertising (45.5 per cent) and slightly more than half participated in community outreach events (51.5 per cent).Conversely, 73 per cent expressed interest in recruitment materials such as brochures and posters, while 64.5 per cent wanted support with physician mailings. Though the data may seem contradictory or counterintuitive on the surface, it exposes the need for better site selection and recruitment-focused site training.

Site selection is, arguably, an arduous task that requires both operational and regulatory acumen.Though it may seem obvious, it cannot be overstated that the first consideration in selecting sites should be access to patients.To maximise access, prevalence data may be used to identify sites serving defined patient populations within a specific geographic area.Thorough analyses during prequalification visits will ensure that sites are equipped to recruit patients, prepared for a regulatory audit, as well as capable of protecting trial subjects.

Reinforcement Through Training

Once sites have been identified, the next critical determinant for hitting enrolment targets is to obtain maximum programme buy-in and understanding among investigators and staff. One strategy to achieve this is a best practices webinar series. Sixty-three per cent of global diabetes sites surveyed ranked webinars as an effective recruitment strategy. Attended by investigators and clinical research coordinators at all participating sites,webinars promote personal accountability for screening activity and allow sites to discuss challenges and strategise solutions. Sponsors can maximise webinar participation by offering multiple sessions with at least two date and time options.

Subsequent sessions should cover the rudiments of effective patient recruitment. Sponsors today are more progressive in understanding the value of training investigative sites in patient enrolment strategies,and many invest resources accordingly.Some sites provide training for study coordinators through certification programmes offered by the Association of Clinical Research Professionals (ACRP) and the Society of Clinical Research Association (SOCRA).While these programmes have utility, they largely focus on the principles of good clinical practice, not the specifics of patient recruitment, and they do not have global application.

Sponsors should evaluate sites and plot a training strategy that will have the greatest impact.The training medium will depend on what needs to be conveyed and the audience’s level of experience.Self-paced computer training may be effective for content that is self-explanatory, while interactive programmes may be more useful for other situations. Teleconferencing can also be productive.

In addition, sponsors can augment the enrolment effort by hiring patient recruitment specialists who offer training as a core service.The benefits of such training are evident and enduring.Training improves processes, boosts performance, reduces turnover and raises morale. For example, one sponsor reported a 22 per cent increase in enrolment activity within three months of recruitment-focused site training.Moreover, sponsor-funded training promotes site trust and allegiance. Consequently, when presented with the opportunity to participate in competing studies, sites often favour sponsors who have demonstrated a commitment to their professional development by investing in their training. In becoming a ‘sponsor of choice’, a company may increase its access to high-performing, highly trained sites.

Recruitment Strategies

A multi-dimensional patient recruitment strategy is required to compete globally amid changing industry dynamics.A programme’s viability is determined by its ability to captivate and inform the target audience, meet regulatory standards governing patient communication, as well as allow for accurate tracking, monitoring and metrics reporting.Global recruitment programmes must be developed with an understanding that external initiatives may be less relevant or appropriate in densely populated regions with specialised healthcare institutions than in other areas where patient access is more restrictive due to geographic spread or competing trials. For these regions, tools and materials developed to facilitate patient identification within individual institutions are more appropriate than public awareness-building campaigns. For example, strategies in the US often include social media and direct-to-patient advertising, whereas rest of the world initiatives emphasise physician education and site support.There are various recruitment programme components available to sponsors.

Site Support Materials
These are designed to aid sites in identifying and screening patients for trial participation.Components include pocket protocols, inclusion/exclusion booklets or cards, study flowcharts, pre-screening worksheets, and informed consent flipcharts. Study flowcharts as well as inclusion/exclusion booklets and cards may be most useful for sites.

Community Outreach
This fosters study awareness among patients not currently known to sites and may include speaking, exhibiting or participating in special events, fundraisers and health fairs.Associations and support groups are usually targeted, as well as community clinics.

Physician Education Packages
These provide potential referring physicians with study details required to refer their patients for trial participation. The package may include a physician-tophysician letter, physician brochure, inclusion/exclusion reference card and study-branded folder, and is sent to physicians who see patients with diabetes in close proximity to sites.

Direct-to-Patient Advertising
Diabetes patients frequently self-identify in response to targeted media campaigns. The mixed-media programme includes print, radio, television, social media and pay-per-click advertising on top internet search engines.A pre-screener is layered into the study website and its effectiveness is measured via performance analysis and metrics reporting.

The trial sponsor has the authority to require a patient recruitment plan compliance among clinical sites. In some cases, sponsors allow sites to select strategies from the plan at their own discretion. If this is the case, measures must be established that define how and where initiatives will be deployed.Additionally, sponsors should establish written policies pertaining to patient recruitment strategy non-compliance.

Maintaining Momentum and Motivation

Frequent communication is essential to keeping sites informed and engaged throughout a clinical trial. There are various tools to support this effort, including site newsletters, electronic communication, study websites with site pages, and even branded support items that promote study awareness.Within the site schematic, the clinical research coordinator indisputably holds one of the most vital positions in the context of patient access.Working in tandem with principal investigators, coordinators are responsible for screening eligible patients and establishing a positive rapport with them, as well as recording accurate and timely data, reporting adverse events promptly to the sponsor and ensuring safety for all research participants.

Having a supportive trial sponsor can alleviate the pressures clinical teams experience every day. Establishing a positive rapport with sites before a study is initiated is an important step. Additionally, encouraging camaraderie and cooperation within each site is a strategic move.

Conclusion

A number of variables contribute to the success of a clinical trial. Among these are the establishment of rapport, trust and mutual commitment to study goals among research sites, the CRO and the sponsor. From these relationships arise enthusiasm among sites to embrace and execute recruitment strategies.Taking the time to invest in relationships may be the best recruitment strategy of all.


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Diana L Anderson, president of DAC Patient Recruitment Services, is an international thought leader in patient recruitment and retention for clinical trials. Over two decades she has addressed audiences across five continents and authored four authoritative industry books. Her upcoming book, Global Issues in Patient Recruitment and Retention, is scheduled for release by CenterWatch in 2012 and will provide an in-depth analysis of topics affecting global clinical trials. She was selected by the Global EXEC Women’s International Council as the 2009 International Woman of Influence and has been inducted into the PharmaVOICE “100 Most Inspiring People in the Life-Sciences Industry”. Email: danderson@dandersoncompany.com
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