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European Pharmaceutical Contractor

Pick and Mix

Recruiting patients is one of the most important steps in the run up to carrying out clinical research. However, with the range of innovative advertising options available in the media portfolio, from print to online, patient recruitment can be carried out more efficiently and effectively.

Selecting the right media for the recruitment of study participants in Europe is not solely a multinational, multilingual and multicultural challenge. Other factors play an equally important role, and require precise analysis of the target group, and consequently the patient population.The result is usually a specific media mix that differs greatly depending on the individual indication and criteria of the clinical trial. A media panacea does not exist for patient recruitment, just as it does not exist for the medicinal treatment of diseases.

Europe versus US

The use of advertising within the scope of patient recruitment for clinical studies is permitted in the majority of European countries and also has the approval of ethics committees. This means that the legal basis for its use is defined. However, despite the positive regulatory environment, patient recruitment activities in Europe still lag behind the US. In the last three to five years it has been observed that the number of studies which are supported with patient recruitment measures in Europe has increased markedly. This trend has been driven by sponsors from the US, who wish to support their studies internationally.

For most studies, patient recruitment in Europe differs from the US in terms of the smaller number of patients and investigator sites used per country. This results in much higher set-up costs due to the considerable number of required country adaptations and translations. Studies often fail to reach a critical mass in individual countries, preventing the effective use of media tactics which are successfully employed elsewhere, particularly radio and TV.

While the media mix in Europe may differ, the underlying approach to developing a successful international patient recruitment strategy is the same around the world. It begins with a thorough analysis of the study, particularly with a focus on its parameters as they pertain to the selection of the specific patient population. The sooner the definition of such a strategy can be incorporated into a study’s design, development, implementation or adaptation, the greater its influence on the study parameters and, therefore, on the choice of recruitment measures. Even minor adaptations to study parameters made early can have a significant influence on the studies performance later on down the line.

Study Parameters

A number of study parameters influence the size and accessibility of the required patient population, as well as the type and number of employed media tactics or accessed information sources:

  • Study population/target group – relevant inclusion and exclusion criteria, such as the indication area sought, age group, gender and other factors, which effectively limit the prevalence of the relevant illness, and therefore influence the size of the target group for a media campaign
  • Study locations – the countries chosen by the sponsor, the number of investigator sites and their locations, keeping in mind the local overall population, the regional prevalence and the choice of possible media measures, which can be applied to the restricted target group
  • Site – the number and type of investigator sites which are used (for example, university hospital, medical surgery and research establishment) and what capacities they have to accommodate the responses to a media campaign
  • Competing trials – trials that vie for the site’s attention, and which possibly dominate certain media measures, can limit the target group further

Furthermore, there are two essential features which influence the framework of a media campaign:

  • Media budget – the size of the budget and time allocation, taking into account the planned duration of the recruitment period and what portion is available for a respective campaign
  • Budget allocation – whether the media budget should be distributed among the investigator sites or be centrally managed by a respective patient recruitment service provider. In the latter case, possible synergies (for example, national campaigns) are optimally used during the planning of the campaign

Media Portfolio Analysis of the study parameters needs to be coupled with the identification of appropriate media tactics to create an effective media strategy. A European strategy will typically utilise measures from the following media portfolio (see Table 1).

Print Advertising
Access to print advertising is relatively easy to obtain and fairly inexpensive, making print popular with sponsors and sites. However, the local print advertising know-how available will determine its effectiveness, and depending on the quality, substantial production costs can be incurred. Regional targeting is good; the quality of the contacts is usually not as good as is the case for online advertising, due to the larger circulation areas of print media. In addition, there is a need for either a call centre or sufficient capacity at the sites in order to answer phone calls resulting from the marketing campaign, incurring further costs.National print campaigns should only be considered for major studies with many sites in individual countries.

Online Advertising
In all likelihood, online advertising will soon become the premier medium for patient recruitment in Europe. It offers the possibility for patient recruitment with relatively small amounts of money. A study web page or a study portal allows patients to educate themselves about the study and gives them the option to contact study personnel. Most providers, such as Google, permit the setting of a kilometre radius to limit advertising to the immediate surroundings of a given site. Hence, scattering loss is low. Furthermore, costs can be easily controlled because of ‘cost per click’- based adverts. Around 70 per cent of Europeans have online access (and of those nearly 80 per cent search for health-related topics on the internet), therefore online advertising – both in regard to cost efficiency and the targeting options – is clearly superior to the other media tactics in Europe. Not only can campaigns be targeted regionally, but they can also be gender- or age-specific, or relate to certain interest areas. Online advertising basically comprises classical search engine marketing (SEM, for example Google), content and display network advertising with banner ads and inserts in social media (for example, Facebook). In comparison to TV, radio or print, fewer people can be reached within a given amount of time.Major studies, with tight deadlines, might still require additional patient recruitment measures.

Patient Databases
Although patient databases are rare in Europe on account of various privacy regulations, they are very efficient.Of the opt-in databases of individuals that do exist in Europe, most do not contain health-related information and cannot be sufficiently filtered.The costs are very low and reflect the quality of the database, which depends on the data’s accuracy and how up-to-date it is. Provided that the option for the use of direct mailings exists, a good regional, age-specific and gender-specific targeting is possible.The cost efficiency in comparison to other forms of media is somewhere in the average range.

Collaterals – Site and Patient Material
For long-term studies, collaterals (such as flyers, posters and calendars), can be useful. For example, they can attract attention in the waiting rooms of test centres or at events hosted by patient organisations.The production costs depend on the number of copies produced. Such materials are easy to produce and popular with patients, as well as with the sites, because they generally outline the study in a comprehensible way and clarify the study for patients. If a logo or corporate design has been developed for the study, this can also be incorporated efficiently into the material. Sometimes collaterals can be complemented with giveaways or other useful items for both patients and sites.

Radio
Radio advertising can be effective for studies with a very high patient number. In many European countries, effective regional targeting is difficult as many radio stations have a broadcasting range that is too wide. Access to radio media can be easily organised via respective agencies; however, the costs for an effective campaign are high. In addition, the production costs for spots can be substantial depending on the quality. The quality of the contacts generated via radio is also worse than those generated through online or print advertising; radio advertising mostly generates a bundled number of responses, usually in the form of phone calls. These can either be handled by a call centre and processed via a prescreening process, or handled by the sites, provided that sufficient capacity has been developed to handle the calls, which is associated with further costs. National radio campaigns should only be considered for major studies with many sites in the individual countries. In these cases, radio can be effective.

Television
In Europe, most television broadcasting stations are aired nationally. This rarely permits regional level targeting and is, therefore, very expensive. The production costs of a commercial for most European countries is also high, since television viewers generally expect high-quality spots as opposed to animated images or text-only commercials. In addition, the different languages and cultures of the individual countries must be considered, usually requiring significant adaptations for each country. As a result, TV advertising is almost never used.

Case Study
As a function of the defined target group, determined by the study parameters, an individual mix arises for every study, every country and every site, the key activities of the media campaign depending, once again, on the budget. The goal is to achieve optimal coverage of the study’s regions, as is best explained by the following case study. A migraine study was carried out in four countries and in a total of 20 sites. On account of the very complex study design, the recruitment period lasted more than three years. The respective study parameters are summarised in Table 2.

Media Tactics
In the study, almost all available media tactics were used to generate sufficient response. The media budget had been calculated correspondingly and was, by means of regular analysis and evaluation together with the sponsor, consistently maintained and adapted on short notice during the course of the study. The basis for the control and reporting capability of the campaign was a site-independent central campaign management. On account of the described study population, the campaign was focused on women and relevant recruitment measures applied (see Table 3).

Results
Altogether, about 16,000 people either expressed an interest for the study or applied for it. Out of those, more than 6,000 individuals were screened and approximately 150 patients were enrolled. The combination of internet advertising with forwarding to a national, web-based study portal turned out to be the most efficient recruitment method for all study locations in all countries in the long run. The costs per randomised patient for online media were approximately 50 per cent below those for print or radio media. The favourable costs can be explained by the good targeting options of internet advertising and the low price per contact. With a big share of the budget, print media achieved good success for six to 12 months. However, this dwindled after some time and could not be recaptured thereafter. On account of its good coverage, radio advertising was most favourable in terms of costs per individual contact. However, subjects were less qualified for the study than those recruited through the internet or print media advertising. This is due to the large amount of ‘scatter loss’ of the medium. Other measures such as mailings to physicians, bus advertising or patient mailings, achieved little success, although no single attributable reason could be identified.

Conclusion

Overall, there is a broad range of advertising options available for patient recruitment in Europe. These options are also well received by patients. However, an essential issue to consider when selecting media tactics is the need for information and clarification about studies by the respective population in general and the patient population specifically. Only a low percentage of people in Europe know of clinical studies and clinical research in general. Therefore, it is mandatory to provide enough additional information in campaigns, which excludes certain types of media due to cost considerations. All things considered, the internet, with its ability to link information and people, offers the best options for providing the answers to questions on clinical research and individual studies. The positive development of online media, and the relatively new application of this medium for patient recruitment in Europe, will certainly create other novel and innovative methods for patient recruitment in the near future.


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Nils Drews is a physician with substantial experience in clinical research at investigator sites, electronic data management and centralised patient recruitment strategies. After his medical studies at the Universities of Hamburg and Luebeck, Germany, he focused on basic research as a member of the ENFUMOSA study group, funded by the European 5th framework in the area of Environmental Medicine/Asthma Research. He co-founded Varigon AG, a company that provided eCRF solutions, and is a co-founder and Medical Director with Clariness, Switzerland. He is also a regular speaker at conferences. Email: nils.drews@clariness.com
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