Engage Sites and Build Study Visiblity Through Good Effective Communication Practices

The frenzy of managing the many details of clinical trials often leads sponsors, contract research organizations (CROs), and investigative sites to let go of a key performance driver – maintaining effective communication. This is occurring at a time when good communication among business partners is increasingly recognized by industry as essential for improving output. [1]

Fortunately, there are forward thinkers in the pharmaceutical sector who have identified the strengthening of communication and the building of better relationships among clinical stakeholders as pivotal to enhancing site performance [2], a continuing challenge [3]. As part of this effort, smart sponsors are taking steps to structure site relationship management (SRM) programs by engaging in communication activities that may be called Good Effective Communication Practices (GECPs). These are initiatives that consider sites more as valued partners and less as work units hampered by limited access to the sponsor or CRO. The intent of GECP is to improve site performance by increasing the visibility of clinical trials among site personnel so they will pay greater attention to those studies and feel more vested in the outcome.

This article discusses ways that sponsors can increase study visibility, particularly through branding of clinical trials, and developing study communication plans that use multiple methods for communicating a message. Using these approaches, a study has a greater likelihood of becoming differentiated to investigators, study coordinators, and project managers. Through this process, personal relationships are formed, creating trust among the stakeholders and a greater sense of commitment to the project (Figure 1).

Engage Sites First
Typically, stakeholders focus on their expectations of site performance as measured by the meeting of subject enrollment targets; adhering to the protocol; collecting and submitting clean clinical data, and resolving queries in a timely fashion. These benchmarks are inherent features of the work and provide useful metrics of performance, but there is more to clinical trials than conducting a series of perfunctory transactions. For a study to come to life and be successful, sites must be engaged and motivated, and able to differentiate that study from the next. Busy sites are conducting numerous trials, each with its own demands for subject recruitment and other study-related activities, so it is not surprising that studies become blurred in the minds of site personnel, with no one trial standing out.

Through branding, sponsors have the opportunity to increase the visibility of their studies. According to a study described in the New England Journal of Medicine, branded clinical trials enrolled five times as many subjects as non-branded ones. [4] Branding serves as a tool for establishing an identity for a study and brings it front of mind for site personnel in the same way that names such as Starbucks or iPod conjure up images that set them apart from the competition. For clinical trials, this may entail creating an acronym such as ALIVE (Adenosine Lidocaine Infarct zone Viability Enhancement trial) or ACCORD (Action to Control Cardiovascular Risk in Diabetes), and may include a logo.

By using acronyms and logos, branding plays a role in the creation of study documents, recruitment materials, and study implementation aids such as pocket inclusion/exclusion cards, and study visit scheduling tools for staff; and thank you notes and reminder cards, e-mails, or text messages for volunteers. Prior to January 2009, branding could extend further, into the realm of office supplies, including pens, post-it notes, notepads, mouse pads, clip boards, coffee cups as well as patient tote bags. At that time, the Pharmaceutical Research and Manufacturers of America (PhRMA) implemented a revised voluntary Code on Interactions with Healthcare Professionals. One of the changes in the revised code includes a prohibition against distribution of various non-educational items that are adorned with a company or product logo (Chart 1).

Although the PhRMA Code is voluntary, some sponsors are excluding all branded items, including company brands, product brands and study brands, even though this isn’t explicitly mentioned in the Code. Some are also using greater restrictions on gifts, such as site recognition items, in order to comply with the spirit of the Code. Regardless of the interpretation of the PhRMA Code in relation to proving branded items to sites, branding is an effective way to maintain study visibility and create an identity and sense of community around a particular trial.

GECPs Raise Study Visibility
With opportunities for branding as well as face-to-face site interactions becoming more limited, site relationship management (SRM) takes on an increasingly important role. SRM is about the sponsor’s use of Good Effective Communication Practices (GECPs) to help principal investigators, study coordinators and other key site personnel build loyalty and a sense of commitment to a sponsor, which hopefully will translate into better performance. GECP is a convenient mnemonic for a series of activities designed to cultivate the social bonds, trust and credibility necessary to create good relationships between sponsors and sites and encourage study differentiation.

To start the GECP process, the sponsor’s internal study team needs to create an impactful message or a series of messages about the trial to reach all of the sites. Is the message memorable and meaningful? What is the right media mix for reaching sites? How frequently should sites receive messages about the studies? Answering these questions starts from the perspective that messages need to be crafted and presented in various ways in order to be remembered by the targeted audience. In fact, an acknowledged marketing principle states that a message must be presented three times in three different ways in order for it to be remembered once [5]. For example, a message that is distributed three times each by e-mail, by weekly phone call, and via face-to-face (F2F) meeting is likely to be remembered only one time.

The GECP approach suggests that sponsors track how messages are shared with the sites by drafting a site communication plan, which details the frequency and manner of delivering the message (Table 1). It is meant as a planning tool to help the internal study team think about the number and type of touchpoints between the sponsor and the site most likely to build study awareness.

In Table 1, the message (“Remember Our Study”) is delivered repeatedly throughout the year, using different modalities, such as an investigator meeting, initiation visit, etc. Similarly, the message is presented at Web meetings, face-to-face visits and through various other mechanisms.

Engaging principal and sub-investigators is one of the greatest challenges. They are intensely busy, and as physicians, they may have private practices in addition to the multiple trials they may be conducting. According to the literature [6] and to Animedix Clinical, a provider of productivity and collaboration strategies for the healthcare industry, physicians are attracted to the innovation and science behind clinical trials, so it makes sense to engage them on this level. The focus on innovation can start at the investigator meeting and extend into the trial, bringing the science and the Investigator Brochure to life. Through its proprietary software, Lattice Connections, Animedix offers tools for this purpose that are outside the normal realm of weekly phone calls and newsletters. For example, a personalized electronic message and video greeting to a specific doctor can be constructed that highlights important safety findings and their implications. Modules can be rendered interactive and can offer links to podcasts and videos on subjects of interest, such as a computer animation of the compound’s mechanism of action.

This is one more way to reach out to stakeholders who are in a position to impact study performance. If contact between sponsors and sites is limited to the weekly phone call, or if the clinical research associate (CRA) only interacts to resolve queries or to have forms completed, opportunities to build relationships slip away. Ongoing challenges with site performance indicate that continuing with the dry transactional approach does not yield the kind of bonds and commitment needed to drive study success.

Soft Skills Add Value
In the pharmaceutical industry, with its sharp focus on technology and integration of electronic tools to boost productivity, the value of good communication as a way to enhance site performance is often given short shrift. While the importance of clean clinical data and its link to earlier detection of safety signals cannot be overestimated, the gathering of clean data may actually be facilitated if there is greater commitment to study performance on the part of stakeholders. With many sites conducting multiple trials simultaneously, it makes sense to propose that studies for which sponsors have created a sense of community are more likely to grab and maintain the site’s attention.

Sponsors can brand studies and implement Good Effective Communication Practices to increase study visibility by clarifying the roles of study team members, and making it easy for study coordinators and investigators to know the right contact person. Leaving sites confused as to whom they should contact, or failing to respond to their questions does little to advance the intent of a clinical trial. Similarly, after the investigators’ meeting, if there is little or no contact between an investigator and the sponsor’s medical director, for example, it is not surprising that loyalty is limited.

Success in delivering clinical trial results depends on the extent to which the investigator and site personnel are committed to the sponsor’s trial, which is a direct reflection of the strength and quality of the relationship they have with the study team. In the end, clinical research is a people business, and recognizing that factor makes the work more meaningful and effective.

Corresponding Author:
Beth Harper, BS, MBA
Clinical Performance Partners, Inc.
1124 Charleston Court
Keller, TX  76248
T: 817-946-4782
F: 817-379-1197
E: bharper@clinicalperformancepartners.com
www.clinicalperformancepartners.com

References:
[1] Lang A, Paravincini D, Pigneur Y, Rivaz E. From Customer Relationship Management to Supplier Relationship Management, HEC Lausanne, University of Lausanne 2002, http://inforge.unil.ch/yp/Pub/02-SRM.pdf, (accessed May 6, 2009).
[2] Harper B, Neuer A. Good Site and Sponsor Relationships Pay Off. Applied Clinical Trials. January 2008; http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor+Articles/Good-Site-and-Sponsor-Relationships-Pay-Off/ArticleStandard/Article/detail/483705, accessed May 7, 2009.
[3] Lamberti MJ, ed. State of the Clinical Trials Industry. Thomson CenterWatch. 2005;pp. 147-8.
[4] Stanbrook MB, Austin PC, Redelmeier D. Acronym-Named Randomized Trials in Medicine—The ART in Medicine Study. N Engl J Med. 2006;355:pp. 101-2.
[5] Truell A, Milbier M, Advertising, Encyclopedia of Business, 2nd Edition, 1999, p.4, http://findarticles.com/p/articles/mi_gx5209/is_1999/ai_n19125601/pg_4, accessed May 7, 2009.
[6] Glass HE. The Importance of Medical Innovation in an Investigator’s Decision to Take Part in Clinical Trials. Drug Inf J. 2008;42: pp. 537-54.