Protocol Design and Recruitment Strategy
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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.
Protocol Design and Recruitment Strategy
- 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