Applying marketing thinking to the clinical trial process
In order to attract and retain patients for a clinical trial, clinical teams should start early on planning and implementing their marketing strategies. Ken Wallace suggests the patient recruitment questions every clinical team should be asking to ensure success.
When deciding how to recruit patients for a clinical trial, a parallel can be drawn between how a pharma product manager prepares for the launch of a new product and how a clinical trial manager prepares for the launch of a protocol. For both, a marketing approach is crucial. However, there is one major difference between the clinical and marketing sides: without exception, pharma companies understand the need to develop and execute a comprehensive integrated marketing programme, while in clinical, this is still considered optional.
Upon approval of their product, product managers never assume prescriptions will be written. They implement an entire programme designed to create and sustain awareness of the availability of the new product. Among other specialised strategies, they work with myriad partners such as advertising agencies, public relations firms, medical education companies and, of course, a sales force, to ensure that the people who need to be made aware of this new product are made aware.
"Why is there still an expectation that even a single patient would be enrolled without some sort of marketing programme to create awareness of the trial?"
On the clinical side, however, 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 enrol 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 programme 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 programme to increase the chances that their clinical trial will enrol on time.
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 programme to create awareness of, and enrol 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 programmes 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?
Another key question is: 'What are the alternatives to centralised integrated patient recruitment programmes?' When speaking of 'integrated programmes' 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 enrol patients. Sponsors may provide sites with recruitment budgets, but essentially they believe (perhaps expect or hope) that the sites will enrol 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 programme.
"Individually the sponsor may end up with the components of an integrated programme, but without the cohesiveness of consistent messaging and an organised strategy"
Perhaps a sponsor may also employ single-tactic or by-request recruitment support. 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 programme, but without the cohesiveness that an integrated programme would bring in terms of consistent messaging and an organised strategy.
The next question that arises regarding provision of this piecemeal support is who at the site will be responsible for planning and executing the marketing plan? Many sites rely on the study coordinator, office manager or other administrative personnel (receptionist?) to plan and execute integrated marketing programmes. 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 specialises in marketing?
Marketing is both an art and a science, and it is not as easy as it seems. From identifying target audiences, to drafting copy, to determining the best mix of tactics, and balancing strategy and creativity, there are nuances that experienced marketing people can more effectively address, all to ensure the marketing programmes are as effective (and cost effective) as possible.
So, when should clinical teams start planning for patient recruitment? Well before a new pharmaceutical product is approved, 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.
On the clinical side, in contrast, 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 programme has the best chance of success. At all costs try to avoid 'rescue mode' because, as anyone who has experienced it knows, rescue mode is neither an efficient nor cost-effective time to recruit patients.
Even today, applying marketing thinking to the clinical trials process is the exception rather than the rule. However, by asking these questions for every protocol, sponsors can better assess the opportunities that exist to increase the chance that their clinical trials will enrol the patients they need on time.
About the author:
Ken Wallace, MBA, is president, Clinical Trial Marketing Communications (CTMC), and through a joint venture, vice president of operations, Integrated Clinical Trial Services (ICTS). He has spent the past 20 years planning, developing and executing marketing programmes to support patient recruitment and retention for clinical trials. He founded Clinical Trial Marketing Communications (CTMC) in 2004. Previously he served in many capacities at patient recruitment company, Clinical Solutions, most recently as president and chief operating officer.
At CTMC and ICTS, he is responsible for developing and managing integrated patient recruitment and retention programmes for pharma sponsors, contract research organisations and site management organisations.
Mr Wallace has developed and managed US and ex-US patient recruitment programmes for therapeutic categories including neurology, cardiology, oncology, gastroenterology, orthopaedics, women's health and endocrinology. He has directed national and local media relations programmes, managed the development and placement of targeted advertising, implemented direct-to-patient and direct-to-physician programmes, planned and executed online marketing plans, and established relationships with key associations and organisations.
He frequently writes and speaks about topics relating to patient recruitment and patient retention.
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