1) Recruitment strategy should be developed during protocol design rather than waiting until after protocol completion and site selection. Starting recruitment planning early increases the chances of enrollment success. 2) Marketing support is usually necessary for clinical trials as relying solely on investigators and sites often leads to under-enrollment. Integrated marketing programs are needed to create awareness of trials. 3) Recruitment support should involve a cohesive, organized strategy with consistent messaging across sites and tactics, rather than leaving recruitment planning to individual sites. Specialized recruitment professionals usually have better marketing skills than clinical staff.

1. Protocol Design Is The Time
For Recruitment Strategy
Gregg Sweet, MBA
VP Strategy and Development
Gregg.Sweet@ICTS.us
o. (919) 388-3966
c. (919) 523-3717
www.icts.us

2. Pre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Recruitment Strategy
When Should You Begin?

3. Recruitment Strategy
When Should You Begin?Pre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Protocol Development Should Include Recruitment Strategies
On the clinical side, planning for patient recruitment often doesn't begin until the
protocol is complete and site selection has begun. It is important to start as quickly as
possible to ensure that the program has the best chance of success. By doing so,
sponsors avoid 'rescue mode' because, as anyone who has experienced it knows,
rescue mode is neither an efficient nor cost-effective time to recruit patients.
Sponsors must ask themselves these questions.

4. Marketing
Expectations / ExperiencePre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Does Marketing Matter?
On the clinical side, it seems that some trial managers believe that when the protocol
is complete and the sites are selected the patients will be beating down the door to
participate. Even today, with all the history that is available and the data that show
that the vast majority of clinical trials fail to enroll the targeted number of patients on
time, ‘Why is there still an expectation that even a single patient would be enrolled
without some sort of marketing program to create awareness of the trial?’
Pharma companies accept that they need to make a marketing investment to ensure
that prescribing physicians and, increasingly, patients, are made aware of the
availability of a medication. However, even today, more than 20 years after patient
recruitment became a tool in the clinical trial completion toolbox, it is still the
exception that companies invest in a marketing program to increase the chances that
their clinical trial will enroll on time.

5. Recruitment Support
What / WhyPre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Do We Need Recruitment Support?
Pharma companies (aka sponsors) are asking, 'Do we need patient recruitment
support for this protocol?' It is great that this question is being asked, but perhaps
sponsors should ask, 'Do we not need patient recruitment support for this protocol?'
History shows that, more often than not, support will be necessary.
There are other important questions to be asked as well, such as, 'Why do we need
an integrated marketing program to create awareness of, and enroll patients in, a
clinical trial?' This is an easy one to answer. If a clinical trial is thought of as a 'thing'
or an opportunity, and marketing communications, including advertising and other
outreach tactics, are ways that people learn about things or opportunities, shouldn't it
follow that marketing communications programs could be or should be the way that
people who need to know or would like to know about the availability of a clinical trial
should be informed?

6. Integrated Program
Develop / ExecutePre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Do We Have An Integrated Program?
Another key question is: 'What are the alternatives to centralized integrated patient
recruitment programs?' When speaking of 'integrated programs' it generally means
developing and executing a trial-wide plan that includes a variety of materials and
tactics designed to reach a core target audience at places and times where they are
most available, most amenable to receiving those messages, and are most able to
respond.
The alternatives generally involve relying on the investigators to find and enroll
patients. Sponsors may provide sites with recruitment budgets, but essentially they
believe (perhaps expect or hope) that the sites will enroll all of the patients for which
they have been contracted. If enrolment lags, perhaps sponsors will add sites or
launch the trial in other countries. Perhaps at this point a recruitment budget, which
may have been originally withheld, will be offered to the sites – all in lieu of putting
together an overall marketing program.

7. Organized Strategy
Cohesive / ConsistentPre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Cohesiveness, Consistent Messaging
Perhaps a sponsor may also employ single-tactic or by-request recruitment support.
So the question is ‘Do We Have Cohesiveness, Consistent Messaging and an
Organized Strategy?’
This means that if a site wants to place a newspaper or radio advertisement, it will
have it funded by the sponsor; or if the site creates a brochure or direct mail letter,
the sponsor will review and approve it. Individually the sponsor may end up with the
components of an integrated program, but without the cohesiveness that an
integrated program would bring in terms of consistent messaging and an organized
strategy.

8. Planning & Execution
Site / ProfessionalPre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Leave It To The Professionals
The next question that arises regarding provision of this piecemeal support is …
‘Who is responsible for planning and executing the marketing plan at the site?’
Many sites rely on the study coordinator, office manager or other administrative
personnel (receptionist?) to plan and execute integrated marketing programs. Of
course, some sites do have internal marketing infrastructure, but … ‘Should we
expect a nurse, doctor or administrator to have better or worse marketing skills than
someone who specializes in marketing?’

9. Conclusion
Protocol / Recruitment Strategy
Pre-Trial
Preparation
Recruitment/
Enrollment
Retention/
Compliance
Enrollment
Success
Recruitment Strategy As Part Of The Protocol
‘When should clinical teams start planning for patient recruitment?’
The answer is simple … Well before a new pharmaceutical product is approved and
when pharma product managers have all of their partners and plans in place. They
do not wait for the approval letter to get started. Most of the planning is done well in
advance.

10. For more information contact:
Gregg Sweet, MBA
VP Strategy and Development
Gregg.Sweet@ICTS.us
o. (919) 388-3966
c. (919) 523-3717
f. (919) 324-3501
www.icts.us