Author:
MARTIN LEE, MD
Vice President, Investigator Relations, PRA Health Sciences
Key Customers in Clinical Research
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Enrollment in clinical trials is heavily dependent on two
very important customers: the research subject and the clinical trial
investigator. Research subjects are highly valuable since it is obviously
impossible to complete a clinical trial without a willing group of
participants. There are many groups and even entire companies that specialize
in engaging potential subjects and connecting them to clinical trials
(Centerwatch 2004). A variety of “direct-to-patient” strategies are used to
engage potential subjects, including traditional media advertising (TV, radio,
newspaper), Web-based strategies (including social media), and community
outreach among others.
The effectiveness of these strategies depends on two key
factors: the ability to reach potential trial subjects directly and the ability
to easily communicate the benefit of trial participation to potential
participants. For some types of studies, direct-to-patient strategies are
highly effective and may be all that are needed to ensure that enrollment goes
smoothly. For many other trials, however, the effectiveness of
direct-to-patient approaches is lower, as the condition being studied may be
less common or the trial may be complex in its goals or design.
THE CLINICAL TRIAL SITE AS A CUSTOMER
The clinical trial “site” is composed of many different
customers, most importantly investigators and research staff. Engaging each customer requires an
individualized approach.
A quality protocol that addresses a relevant clinical
question is the first need of clinical trial investigators. The protocol must
be well written and provide clear and appropriate eligibility criteria, a
succinct and accurate description of study procedures and accessible dosage
modification criteria. Provision of easily followed guidelines for managing the
drug’s side effects is extremely helpful. Investigators also need the detailed
information contained in the Investigator’s Brochure to further assist with
understanding the trial rationale and help assess toxicities that may be
experienced by individual patients.
In addition, when investigators are engaged on a scientific
level, they are able to take ownership of the success of the study. While
comprehensive training on the scientific background often occurs at the site
initiation visit and investigator meeting, ongoing reinforcement of the trial’s
key messages and showing sincere appreciation for the investigator’s efforts
should occur throughout the course of the trial. Where possible, this
reinforcement and recognition should come from a sponsor or a CRO personnel who
has the skills to discuss patient care and science at the level of the
physician.
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Having effective research staff at each site is critical to
enrollment performance. The ability of the research staff to interact with both
potential subjects and investigators creates an environment in which the site
can perform to its fullest potential. Their key duties include:
•_ _Establishing an effective pre-screening strategy to
recruit or identify potential subjects within the site
•_ _Communicating the benefits of clinical trial enrollment
to both patients and physicians
• Training of all site staff, including data managers and
research assistants
• Interacting with sponsors and CROs
• Maintenance of complete study records
• Timely data entry and response to queries
Because both the number of duties that fall on the research
staff and the complexity of those duties are high, keeping these tasks as
simple and easy to perform as possible should be a primary goal. In this
effort, sponsors and CROs should strive to make the staff’s lives as easy as
possible and to demonstrate that they genuinely care about keeping their lives
simple. Both of these are critical to building trust, which is a cornerstone of
developing and maintaining engagement. In addition, a balance must be
maintained in the relationship, as there are needs of the study that at times
may require the research staff to “go the extra mile” to meet a deadline, such
as a data sweep prior to a data management committee meeting or database lock.
The following list provides a summary of factors that can help to maintain
effective research staff engagement:
The traditional medical science liaison (MSL) role has
expanded since its inception in the late 1960s and today focuses on advancing
standards of care and optimizing patient outcomes (2010; 91[3], 394-398). While
in previous years this role was often part of sales and marketing, more
recently in most pharmaceutical companies the MSLs are generally part of
medical affairs. The primary duties of a typical pharmaceutical MSL include
management of key opinion leaders (KOLs) as well as providing detailed
information to healthcare providers on marketed products, including the
background science, clinical trial results and post-marketing experience. In
addition, MSLs frequently interact with pharmacists, pharmacy benefit managers
or health insurers. Depending on the company, internal customers of the MSL may
include sales, marketing, clinical development and medical information
departments.
The clinical trial liaison (CTL) is a specialized role
modeled after the MSL but is exclusively focused on engaging sites
participating in clinical trials. The CTL works with all the sites on the trial
to ensure that all investigators and study staff continue to be fully engaged
throughout the course of the trial. In contrast to the clinical research
associate (CRA), who usually is working on only a single study, the CTL serves
as the consistent face of the sponsor or CRO across multiple trials. A longer
term benefit of the CTL for the sponsor or CRO is the ability to select sites
that are more likely to effectively perform on future clinical trials.
The interaction of the CTL with the site begins at the time
of the site initiation visit. At this time, the CTL presents the scientific
rationale for the study and discusses the eligibility criteria and study procedures
in detail with the principal investigator (PI). Any feedback from the PI is
provided back to the study team quickly. Once the trial is active and
throughout the course of the trial, the CTL works with the PI to be certain
that current information is available on the molecule’s development and to
engage the PI in discussions on the study as well as on potential other areas
for development. The degree of study awareness among sub-investigators is
variable at most centers. The CTLs also meet with the site’s sub-investigators
(including fellows, physician assistants and nurse practitioners where
applicable) to help maintain focus on the study’s overall design, rationale and
eligibility criteria. With research staff, the CTL works to ensure that
appropriate pre-screening procedures are implemented so that all potentially
eligible patients are considered for study participation. The CTL also provides
supplemental training on more complex study procedures when required. In
addition to working with each site independently, the CTL coordinates
communication between sites in small group teleconferences and in small group
meetings designed to maintain enthusiasm over the course of the trial.
The value proposition for clinical investigators and
research site staff interacting with the CTL includes better understanding of
the scientific background and clinical trial design, as well as the ability to
have their site considered for future clinical trials that are of interest to,
and will successfully enroll at, the site. The CTL also serves as a familiar
point of contact for the site, responds to requests and serves at the point of
contact between the trial medical monitor and the site when potential
performance issues are identified.
The ability to engage investigative sites throughout the
course of a clinical trial is a critical success factor for both enrollment and
data quality. By building trust, respect and appreciation for the very
difficult job of conducting clinical research, we can help to ensure the
successful completion of our clinical trials. In doing so, it is important to
realize that our sites are not a single customer, but a collection of customers
with different desires and needs, and we must tailor our strategies to
effectively engage them.
The CTL role has evolved to meet the needs for site
engagement over the course of the trial and represents a new approach that has
the potential to significantly impact enrollment. PRA has implemented a fully
compliant CTL program to support our ongoing trials. The service is staffed by
physicians in PRA’s Medical Affairs and Therapeutic Expertise groups and by
PharmDs and PhDs who have clinical experience and can provide effective
interactions with site personnel throughout the trial. All team activities will
be managed by a program coordinator who will serve as the channel of
communication between sites, internal project teams and the liaisons.
Bibliography
Anderson, D. (2004). A
Guide to Patient Recruitment and Retention. Centerwatch. Boston, MA.
Baker, D. (2010). The
role of the medical science liaison in industry. AORN J, 91[3], 394-398.
Dasu, S., & Chase,
R. (2013).
The Customer Service Solution. New York: McGraw Hill Education.
For further information
on PRA’s approach to clinical trial research, please contact your PRA Account
Director or the PRA employee below:
Martin Lee, MD
Vice President
Investigator Relations
9755 Ridge Drive
Lenexa, KS 66219
+1 (913) 410-2029
World Headquarters
4130 ParkLake Avenue,
Suite 400
Raleigh, North Carolina
27612 USA
+1 (919) 786-8200 PH
+1 (919) 786-6201 FAX
#ColinShannon #MrColinShannon #PRAhealthsciences @MrColinShannon
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