Good recruitment practice (GRP) is an initiative that both articulates and embodies this approach. Adopting GRP principles provides an effective means of cultivating a positive dynamic and productive relationship between site staff and subjects. Moreover, GRP paves the way for meaningful interactions—the kind that help ensure on-time enrollment and retention.

Good recruitment practice
Good recruitment practice is a set of principles for improving the recruitment of both subjects as study participants and physicians as investigators by combining the best practices of clinical research with the marketing science of health care communications. The ultimate goal of GRP is to improve the benefits afforded to subjects who participate in clinical research studies, as well as to those who receive the approved treatments that are developed through clinical research. Specifically, GRP aims to:

• empower subjects to make better-informed decisions about study participation
• enhance the experience of clinical study participation for subjects and physicians
• increase participation of subjects and physicians in clinical studies
• foster awareness and education about clinical research
• improve communication among all parties involved in the clinical research and development process
• support ethical behavior and decision-making related to potential conflicts of interest
• reduce delays and costs in the development of drugs, devices, and other treatments.

• Subject information and communications
• Study design, planning, and conduct
• Investigator-referring physician relations
• Incentives
• Disclosures
• Public awareness and education.

Additionally, one set of principles specifically addresses informed consent. In so doing, GRP directly introduces ideas that may be easily implemented at the study site level to achieve the approach outlined above.

Informed consent vs. informed decisions
The concept of informed decision is an evolution of the process of informed consent that takes into account a more expansive understanding of the subject’s experience.

All participants in clinical studies are required to sign an informed consent form. In so doing, they create an important bond between themselves and the study. Without that signed agreement, there would be no record of a subject’s understanding of and legal commitment to participate in a clinical study after being apprised of all aspects relevant to their decision.

But signing an informed consent form is not enough to create the desired confidence and commitment in the participant that will carry him or her through a study’s duration. That is because a subject has a natural tendency to question his or her involvement in a study over time. Hence, the difference between informed consent and informed decision can be summarized as follows:

Informed consent. When a participant in a clinical study gives his or her consent, he or she agrees to the terms as outlined and signs the form. But for many participants, especially those for whom the study may offer access to investigational treatments otherwise unavailable, this can be a daunting experience. Participants may sign the document in the heat of the moment, only to reflect, upon cooling down later, that they have not fully understood all they have agreed to.

Informed decision. A participant makes an informed decision to participate in a study on a daily basis. These decisions are made based on many factors, not the least of which is the continuing experience as a participant. In a sense, this distinction can be expressed as such—when participants make an informed decision, they become invested in a process they feel a part of, not apart from.

There is a significant difference between the static moment in time when a subject signs the informed consent form and the desired, ongoing state of mind GRP defines as informed decision. It may even be fair to say that fostering an informed decision is a proactive—rather than reactive—approach to both communicating with subjects and supporting them through the recruitment and retention process.

CRCs—the subject recruitment bottleneck
Clinical research coordinators (CRCs) play a pivotal role in creating a communication-rich environment. However, there is concern in the industry about how CRCs must allocate their time to multiple tasks necessary to fulfill their jobs, and whether participants receive enough time and attention to ensure their valuable (and costly) recruitment and participation.

At a time when subject shortages in clinical research studies continue to hamper the progress of bringing new drugs to market, CRCs report that they are mired down in the trenches. A representative survey of CRCs nationwide conducted in April 2003 found that CRCs focus the bulk of their time multitasking at administrative, data, and regulatory requirements of study conduct.1 Results showed that CRCs devote only 13% of their day to finding subjects (8% to “subject recruitment activities” and 5% to “searching medical records for potential study subjects”). Moreover, CRCs commonly manage five studies at a time. The survey also revealed that less than a quarter of the CRC respondents (24%) indicated that they had received any initial training relating to subject outreach techniques.

For all their good efforts, CRCs are hampered in their ability to support overall recruitment, enrollment, retention, and compliance goals in the very earliest stages of the clinical research process due to the crush of numerous and demanding responsibilities. However, it is rarely possible for them to properly conduct subject recruitment and outreach initiatives that are used to maximize informed decisions and, therefore, study enrollment.

When the difference between informed consent and informed decision—and its implications—is clearly understood, it becomes equally clear that fostering informed decisions is the responsibility of everyone in the clinical research community. As such, all those involved in clinical research must devote time and energy to making certain that information is clearly defined, presented, and reinforced through the clinical study.

GRP—an approach, not a set of tasks
Initiating GRP seems as if it will require more time on the part of an already overburdened site staff. If GRP were a set of tasks, that might be true. But, to reiterate, GRP is an approach, a mode of operation in which effective communication is paramount, not a checklist of jobs to be done.

By its nature, the structure of a clinical study often creates an environment in which subjects can interact more intensively than with their own providers. The study protocol, as required by regulatory guidelines, lays out a very clear foundation for this different kind of relationship. Subjects know what to expect in terms of number of visits, types of procedures they will undergo, who they will meet with and for how long, and what kind of support is available between visits. They will also be provided with educational materials to read and better inform themselves.

Sponsors (and the agencies they enlist to conduct subject outreach and recruitment) can help investigators and site staff members enhance this opportunity for interactivity by instilling the importance of good communication skills. Good communication can be expressed in many forms:

Verbal—spending time talking and listening, offering information, and giving subjects time to express their experiences and ask questions.

Nonverbal—welcoming subjects, valuing their experience, listening, and responding to their suggestions, and respecting subjects as partners in the clinical research process.

Moreover, effective communication can be applied at every stage of study conduct:

• Inquiry
• Referral
• Informed consent
• Screening
• Medical visits
• Between visits
• Retention period
• After study completion.

Every interaction with a subject is an opportunity to create the network of relationships that serve not only current study and enrollment goals, but also future studies. “The Will and Why Survey,” conducted in 2001, found that 82% of subjects who participated in clinical studies would do so again, citing as their primary reasons the opportunity to receive better treatment and education about their condition.² The list below offers ways for site staff to enhance their interactions with study participants so that they foster interest and a greater sense of desire to participate in future studies.

Behind the scenes. Before enrolling any subjects, study staff can ensure that the informed consent form is not only accurate, but that they feel comfortable explaining it. To enhance the subject experience, they can reserve parking spots for “subjects only,” send out birthday cards to participants, and help subjects gain access to medical resources they may not be aware of.

First contact. It is essential to equip every site staff member who has contact with subjects—from the principal investigator (PI) and nurse to the study coordinator and front desk receptionist—with the information they need to answer subject questions and the training to do so with sensitivity and compassion.

Informed consent. The initial explanation of the informed consent is best conducted in person with the subject. Avoid mailing it out or allowing subjects to study it alone without initial guidance. Site staff can contribute further by explaining the document in simple, layman’s language and encouraging subjects to consult with a trusted family member or physician. To help subjects know what questions to ask, sponsors and site staff can provide written material and resources about the informed consent process as well as specifics about the study.

Study expectations. Because site staff often rewrite the informed consent provided by a sponsor, they have some control of language and format for ensuring better subject understanding. Site staff can extract the details of the study and then clearly explain them to subjects. What’s involved in the study? How long does it last? How is the study drug expected to work? To supplement the informed consent form, sites can provide specific study expectations in a separate document, in language subjects can understand.

Follow-up. Sites can schedule additional visits and conduct follow-up calls to support and provide continuing motivation for subjects.

Compliance programs to enhance care. Supportive communications from site staff and PIs encourage subjects to comply with study requirements. Examples include notes of acknowledgement, follow-up information to their homes, Web sites, retention techniques, and journals.

Access to technology. Sites with technological support are better positioned to streamline communications between staff members as well as with potential study participants. High-speed Internet connections, email capabilities, database access and training, and sufficient phone and fax lines all contribute to making reports and updates easy and efficient.

Poststudy communications. Subjects in clinical studies are naturally curious about the study’s ongoing status. Communicating milestones such as full study enrollment and study completion and expressing appreciation for volunteer time and commitment helps reinforce the participants’ experience of contributing to science and increases their trust in the clinical research enterprise.

High-quality communication
Good recruitment practice provides clear guidelines for those conducting clinical research to help their participants make informed decisions. The ultimate benefit is to the subjects, as it increases their awareness, understanding, and trust in the clinical research and development enterprise in which they play a pivotal role. GRP also seeks to better educate and alleviate public concerns about subject safety and welfare. Such positive perceptions may also contribute to the willingness of physicians to participate as investigators. GRP thus carries significant implications for improving the system of bringing approved treatments to market. The earlier the principles of GRP are considered in the clinical research and development cycle, the more likely are successful enrollment, better compliance and retention, and faster development cycles.

GRP principles and standards can help to alleviate the bottlenecks to subject enrollment. Since it was initiated in June 2002, GRP has continued to gain industry-wide support.³ An advisory board has been formed, composed of representatives from sponsor companies, institutional review boards (IRBs), healthcare professionals involved in research, and subject advocates. They are collaborating regularly to disseminate the GRP principles, further evidence of GRP’s mission to instill momentum into the clinical research process.

References
1. Internet survey of>350 clinical research coordinators (BBK Healthcare, Inc., 320 Needham St., Newton, MA 02464, April 2003; results available at www.bbkhealthcare.com).

2. “The Will & Why Survey,” Internet poll of>5,000 patients (BBK Healthcare, Inc., 320 Needham St., Newton, MA 02464, June 2001), harrrisinteractive.com/news/allnewsbydate.asp?NewsID=323.

3. J.W. Maloy et al., “Tipping the Scale toward Success,” Monitor, Summer 2003, 11–31.

Joan F. Bachenheimer is a founding principal of BBK Healthcare, Inc., 320 Needham Street, Newton, MA 02464, (617) 630-5515, fax (617) 630-5090, email: jbachenheimer@bbkhealthcare.com.

SIDEBAR: Why We Need GRP
Clinical research coordinators commonly manage five studies each. Only 13% of their days—8% on actual subject recruitment and 5% on searching medical records—is spent finding subjects.¹