Recruitment Roles

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Patient recruitment plays a major role in establishing the objectives and the ultimate success of clinical trials. Yet, targeting the right patients and retaining their participation is one of the greatest challenges currently facing the biopharmaceutical industry.

Traditional recruitment methods have proven inadequate, with the majority of trials failing to enroll a sufficient number of patients in a timely fashion. As the biopharmaceutical industry continues to face challenges such as increasing costs, reduced productivity, and shrinking pipelines, it can ill afford costly delays associated with recruiting and retaining patients for clinical research.

Historically, the responsibility for patient recruitment primarily belonged to investigator sites. Today, sponsors and contract research organizations (CROs) are partnering with sites and a broad range of stakeholders, including operations, site monitors, site staff, and recruitment specialists, to drive enrollment. Sophisticated planning and coordination among all parties is necessary in order to successfully carry out effective and efficient patient recruitment.

In this article, the opportunities available to improve patient recruitment strategies by taking an integrated team approach supported by effective communications, process improvements, and a deep understanding of each stakeholder's role are examined. Topics discussed include:

• Challenges to patient recruitment currently facing the biopharmaceutical industry

• The role of the sponsor and CRO in recruiting and retaining patients

• The role of investigator sites in recruiting and retaining patients

• Communication strategies that best support trial sites in patient recruitment efforts

• The importance of each member of the trial team carrying out his or her role for the benefit of the entire trial.

Changing landscape

Patient recruitment is critically important to the health of biopharmaceutical research activities, and an area of growing concern. Today nearly 80% of clinical trials fail to meet enrollment timelines¹ and up to 50% of research sites enroll one or no patients.²

A lack of study participants poses a major threat to the industry by causing delays in new drugs making their way to market. This translates into as much as $8 million in lost revenue for each day a drug is delayed.¹ In addition, failure to enroll the necessary number of patients at each investigator site in a timely manner can compromise a trial's statistical power and scientific validity.³

Challenges to patient recruitment have been exacerbated in recent years by a number of factors. For one, there has been a dramatic expansion in the number of trials being conducted, which has heightened competition for patients. At the same time we've seen an increase in trials, the number of new investigators has not increased significantly. Between 2000 and 2007, the volume of studies has increased by approximately 15%, and the number of new investigators has declined by 10%.⁴

Increasing study complexity and eligibility criteria is another contributing factor to lower patient enrollment and retention rates. Over the past decade, the average eligibility criteria for clinical trials have increased by 58%, while volunteer patient enrollment rates dropped by 21% and retention rates fell by 30%.⁴

With a more competitive landscape, advances in recruitment practices must be implemented if the biopharmaceutical industry is to meet the growing demand for patient participants. In large part, that will require a thorough re-evaluation of the roles and responsibilities of trial professionals; each member must focus on mastering his or her particular area of specialty in the service of the larger goal of the trial.

Figure 1. Growth in the number of new studies is met with declining growth in the number of investigators.

Role of the sponsor and CRO

The sponsor, and by extension the CRO, plays a key role in facilitating a clinical trial site's patient recruitment activities.

Good communication with potential sites. A clear channel of communication between sponsors/CROs and trial sites is essential to successful patient recruiting efforts. In order to establish a more collaborative and, therefore, more informed approach, sponsors/CROs should consider strategy meetings and direct discussions with sites early on to learn about key obstacles and suggestions for operational efficiencies. These meetings should be used to define the elements of the protocol that will create challenges for patients and/or site personnel. This information can be used to make appropriate protocol modifications and to define the key areas to address when communicating with patients. It's important that investigator sites are given the information necessary to evaluate all aspects of a study's feasibility. Sponsors/CROs that are candid up front about potential challenges and provide adequate time and information to trial sites will benefit in the end from the more accurate information gleaned from this process.

Establishing protocol criteria. Overly complex or unrealistic protocols are one cause of trial delays and have a negative and costly impact on the ability to enroll and retain patients. The feasibility of a trial, therefore, must be carefully examined to ensure that assumptions made early on are supported by a comprehensive set of data collected from multiple sources.

Supporting chart review. Allowing investigator sites to conduct a thorough review of patient charts as part of the planning process is an important step in identifying and enrolling appropriate trial participants.

The process of carefully reviewing patient charts and evaluating them against protocol criteria requires a significant commitment of time on the part of investigator site staff. If the job is to be prioritized, the sponsor/CRO should consider compensating staff for this important task. Providing financial support for the time it takes sites to mine their medical charts for potential trial volunteers makes it possible for sites to invest the resources necessary to thoroughly carry out chart reviews and focus on rapidly recruiting the most appropriate patients.

Use of EMRs. Leveraging electronic health data is a critical tool for establishing more sophisticated patient recruitment strategies throughout the industry and will play an increasingly significant role in helping to coordinate the efforts of trial teams as they are adapted across the medical profession.

For practices currently using electronic medical records (EMR), sponsors/CROs have an opportunity to capitalize on this technology by providing resources to help the site work through their EMR system to conduct feasibility assessments and identify appropriate patients. Some EMR vendors, for example, have the capability to write a trial protocol query that an investigator site can run against their patient database to identify potential trial participants. This can be a very effective way of identifying patients who might be appropriate for the trial, and is a tool that the sponsor should consider.

Using site communication materials. Approximately 69% of non-participation in clinical trials is the result of a lack of awareness that a trial is even taking place.⁵ That underscores how critically important effective communication is to the success of patient recruitment, and ultimately, to the trial itself.

There are a number of ways to most effectively get the message out about a trial. First, the sponsor/CRO should provide each investigator site with patient communication materials. Brochures, posters, placards, and pocket tri-folds can accomplish two important objectives:

• Keep the study top-of-mind for trial site staff so they remember to offer the study as an option for the patient

• Help facilitate communication between staff and patients

When written without medical jargon and in terms that patients can easily understand, communication materials at the trial site play an important role in helping patients become more informed about what it means to be a trial volunteer.

Quintiles has tracked and evaluated the impact of distributing site materials and found that well designed communication tools drove a 20% to 60% increase in consented patients willing to be screened. It was found that there is a greater benefit to distributing these materials early in the trial.

Locating patients outside a practice. Supporting sites in the effort to identify and recruit patients from outside of a practice also relies heavily on well-crafted patient communications and is an area in which sponsors/CROs should take an active role.

Today, it's more important than in previous years to help sites reach beyond their practices to find patients. Increased competition for patients and recognition that advertising is not typically an area of expertise at the site level requires communication professionals to join the team and establish the most effective channels by which to reach the patient population of interest.

As a starting point, marketing research is necessary in order to uncover the key issues and questions patients have about participating in a trial. This plays a critical role in the development of appropriate messaging aimed at encouraging and enabling patients to seek more information about participating in a clinical trial.

Sponsors/CROs can then make it easy for sites to advertise by supporting them with media buying expertise to ensure that the most effective form of media to attract the target patient market is being deployed. To facilitate media buying, some CROs and sponsors provide sites with an advertising tool that allows investigators to select media online and then access the expertise of professional media planners and buyers to negotiate its purchase. Additionally, tracking the results of the campaign can be used to drive process improvement on an on-going basis. In some cases, an advertising account is established so that trial sites simply draw on a fund rather than submit invoices for each media buy.

Finally, sponsors/CROs can make available to sites opt-in databases of patients interested in participating in trials and help the sites pre-screen those patients ensuring only the most qualified applicants are referred. Pre-screening can be done by a call center or online questionnaire that captures self-reported patient information. While it's not possible with this method to address all inclusion and exclusion criteria, basic parameters such as patient age and medications can be covered to improve the likelihood that the patients referred are strong candidates for the study.

Role of investigator sites

Naturally, the investigator sites must also play an active role in recruiting patients for the trial they will conduct.

Standards of care information. Physician investigators, specifically, play a critical role in helping sponsors/CROs understand how patients interact with the healthcare system and how they will move through a particular study. This kind of "on-the-ground information" is essential to sponsor/CRO efforts to establish protocols that are less complicated and maximize convenience for both patients and site coordinators.

Investigators and clinical coordinators should also be involved in reviewing a draft of the study design and provide feedback early on so important adjustments to protocols can be made. It is important to ensure that assumptions are based on data rather than anecdotal experiences.

Contributions to communication/education. By talking openly with patients early on about participating in a clinical trial, sites can solicit feedback to help in the development of educational materials that specifically address patients' most pressing questions and concerns. It also provides an opportunity for site staff to educate patients about the specific benefits of participating in a clinical trial. For example, that their own health will be closely monitored, or that it's an opportunity to contribute to a body of scientific knowledge that may ultimately help treat other individuals who share their illness.

Leveraging recruitment tools. It's important for sites to recognize and leverage the tools and expertise provided by sponsors/CROs. Often, investigators go it alone when it comes to recruiting patients, attempting to market and advertise the study themselves. Expertise regarding how best to implement some of the necessary activities for successful patient recruitment is available through sponsors/CROs and should be utilized. The most effective sites work collaboratively with experts and adapt patient recruitment methods to fit their environment. They do not attempt to master them on their own.

Volunteer follow up. Following up with patients who come to the study through media or opt-in databases is another critically important aspect of successful patient recruiting for investigator sites. A failure to contact patients in a timely manner reduces participation greatly—one study found that sites that waited to follow-up with patients experienced a 68 percent decrease in participation as compared with sites that followed up within one day of referral.⁶

Once recruited for a study, it is important for the investigator site to establish and maintain a relationship with the patient and to manage that relationship proactively. Study volunteers, after all, are giving up a lot of personal time and may be making a significant sacrifice. It's important that investigators keep this fact in mind and treat trial volunteers with a customer service orientation.

Team effort

Sponsors and CROs are increasingly working as partners with a range of research professionals to recruit and retain patients for clinical trials. In today's market, the responsibility for doing so cannot fall to one group of stakeholders, but rather, must be a team effort with all participants doing their job well and in coordination with each other.

One of the greatest mistakes made during patient recruiting comes when professionals from all areas of a trial step too far beyond their area of expertise and attempt to carry out a job that someone else on the team is better trained to do. We all feel we understand what advertising is, for example, because no matter our profession, it's something we're all exposed to in our daily lives. But it's important to keep in mind that the study coordinator or investigator, who plays a critical role in establishing relationships with patients, isn't necessarily the most effective at choosing media or creating advertising messages that are noticed by the target patient population. With access to individuals professionally trained to carry out these functions, engaging their expertise increases the likelihood of a successful recruitment effort.

All trial stakeholders, from physician investigators to site monitors, communications experts to CRO monitors and managers, have an impact on enrollment. All parties must be clear about their specific responsibilities and deliver on their objectives in order to effectively recruit qualified patients and for the entire trial to be a success.

Jim Kremidas is Vice President, Global Head of Patient Recruitment, Quintiles, 4820 Emperor Boulevard, Durham, NC, e-mail: Jim.Kremidas@Quintiles.com.

References

1. Jon Hess, "Web-based Patient Recruitment," (White Paper) Cutting Edge Information, http://www.cuttingedgeinfo.com/process/?ref=122.

2. CISCRP, "Recruitment and Retention," 2006, http://www.ciscrp.org/professional/facts_pat.html.

3. P. Schroy, J. Glick, et al, "A Cost-Effectiveness Analysis of Subject Recruitment Strategies in the HIPPA Era: Results From a Colorectal Cancer Screening Adherence Trial," Clin Trials, 6 (6) 597-609 (2009).

4. K. Getz, "Current Investigator Landscape Poses Growing Challenges for Sponsors," Impact Report. Tufts Center for the Study of Drug Development, 11 (1) (January/February 2009).

5. ISR Reports, "Patient and Investigator Recruitment Success," September 2009, http://www.isrreports.com/report_preview.php?id=20090929.

6. S. Fung, E. Suen, and H. Lee, "Development of a Patient Recruitment Program for Phase II Trials in a Biotechnology Company," Drug Information Journal, 37 (3) 259-270 (2003).