Budgeting for patient recruitment strategies in clinical trials

Patient recruitment costs vary between therapeutic areas, but consistent across diseases is the significant share of a trial budget required to recruit the appropriate participants. Yet in our recent ‘Innovation in Patient Recruitment’ survey, 41% of respondents with buying power had no budget specifically for recruiting participants for research.² Yet, budgeting for and implementing effective patient recruitment tactics from the outset will have a significant impact on the return on investment (ROI) of your study.

Planning a budget for targeted recruitment tactics is necessary to effectively enlist the marketing expertise and financial investment required to take advantage of digital patient recruitment tools, such as online and social media platforms, artificial intelligence, interactive enrollment procedures, and innovative technology. It also allows you to be flexible when certain patient recruitment strategies fail to provide the types or numbers of patients required for your study. Organizing your budget at the outset of patient recruitment, will give you scope to continually review and adjust the creative elements of your recruitment strategy to ensure you meet patient enrollment goals in a timely manner.

Ultimately, planning a budget for clinical study recruitment can help you in four significant ways:

1. Removing the barriers to patient recruitment and enrollment

Eliminating any barriers to participant enrollment is a key consideration when planning a recruitment budget. In our ‘Innovation in Patient Recruitment’ survey, 27% perceived protocol complexity to be the top barrier to patient enrollment. Furthermore, a lack of patient awareness (20%) and a small budget for effective patient recruitment (18%) were identified as significant impediments to the recruitment of study participants. These findings highlight the need to consider effective, patient-centered participant recruitment marketing strategies and enrollment processes when planning your budget.

Technological innovation can be leveraged to break down barriers to patient participation by allowing for remote and virtual data collection, but it can also be used to increase recruitment opportunities and simplify enrollment processes.³ An effective budget plan will provide for the purchase and use of emergent technology to ensure interested patients are not deterred by complex enrollment procedures. The budget will also take into consideration the use of social media and other online platforms that can be harnessed to raise awareness of clinical studies and gather participants from across the globe.

An effective budget will provide funding for enrollment and consent forms to be designed in a way that is straightforward and easy to understand, while the details of what a participant is consenting to should be transparent and easy to identify. A well-planned budget allows the time, resources, and expertise to enhance information provision and reduce study complexity for interested patients, allowing marketing and enrollment materials to be designed in a way that engages and ensures patients are supported throughout the enrollment and study process. Fear-based barriers can be removed by improving user experience and user interface design to ensure technology and other trial processes are created with the patients’ needs firmly in mind.<sup>3</sup>

2. Ensuring you target the right participants using the right platforms

Targeting and recruiting the right patients is essential to obtaining quality participants for a clinical study. Patient personas should be identified in the initial study planning stage, and these will guide your recruitment budget. Consideration must be given to how you are going to target patients who have the required characteristics, including specific clinical indicators such as diagnosis or symptoms, as well as demographics such as age, gender and location.

Identifying these patient personas allows you to understand the needs of the people you want to recruit and guide the choice of strategies you invest your budget in.

You may know the benefits of your study for patients, but effective marketing is required to convey that message to potential participants. Where possible, you should budget for A/B testing of the format and wording used in advertisements, landing pages, and enrollment forms to allow for adjustments to your strategy to ensure the most successful response.

While traditional media outlets tend to garner higher levels of trust than their online counterparts and may hold more sway with older audiences, up to 80% of people use online sources to gather further information about diseases and their treatments.⁴ Therefore, a significant part of your budget needs to beused to harness these platforms.

Compared to traditional media channels, social media and other web-based advertising provide a cost-effective alternative with a greater ability to target advertising to potential research participants who closely match the needs of your study. The personal data collected on these platforms allows for highly targeted audiences based on interests, demographics and locations. They also allow for immediate interaction with, and enrollment of patients.

3. Determine key metrics to measure ROI

A detailed recruitment budget should include a thoroughly researched outline of financial costs and measurable metrics to evaluate the success of different marketing channels. Transparency in budget spending allows sponsors to see how their investment will be implemented, pinpoint those channels that provide the most ROI, and provide measurable and targeted results that will improve study outcomes.

Two studies highlight the ROI that is possible when you plan your marketing tactics into your budget for patient recruitment:

The VERKKO Phase IV trial for diabetes used Facebook as a recruitment method, achieving a conversion rate of over 81% and resulting in 60 patients enrolling in the study.⁵ Several participants were over 70 years old and the average age was 56. The satisfaction rate of participants was high, and the dropout rate was less than 10%, demonstrating the ROI potential when time is taken to budget for the right recruitment tactics from the outset.
Likewise, the Fox Insight virtual study on Parkinson’s disease (PD), open to those with and without the disease, compared organic digital recruitment strategies with paid Facebook advertising.⁶ The recruitment tactics included highly targeted audiences focused on those aged over 60 years, living in the US with an interest in PD awareness. Different content approaches were A/B tested to find the advertisements that garnered the highest response, enabling researchers to increase enrollment by 825%. Of those enrolled, 67% made direct contact via the Facebook advertisements.

These studies indicate that while it may be tempting to rely on organic social media and web traffic when planning your budget, especially because of their lower financial commitment, the likelihood of a successful ROI is much higher with paid digital patient recruitment methods.

4. Completing your clinical study on schedule

Each day a pharmaceutical trial is delayed, it can cost between $600,000 and $8 million in lost sales revenue.⁷ These figures alone provide a strong rationale for investing time in planning your recruitment budget. Not only can it save your study – it can save you money.

Considering in August 2018, there were 281,000 trials registered, less than 5% of patients participate in clinical studies.^8,9As the number of trials and, therefore, the research participants required increases, an adequate budget for patient recruitment becomes imperative to advancing medicine and healthcare.

Despite the importance of participants to a trial’s success, our ‘Innovation in Patient Recruitment’ survey showed that around 30% of sponsors included no budget for patient recruitment strategies in clinical trials. This is alarming considering the huge benefits to be reaped from planning a recruitment budget. A patient recruitment budget is the first step to breaking down barriers to recruitment, it shows a recognition of the important role that patients play in clinical trials by investing in reaching the right patients via the right platforms and at the right time. It also enables you to remain agile and to adapt to the changing or growing needs of your participants to ensure they remain satisfied with their involvement. This is fundamental to preventing attrition and thus completing a quality trial on time.

To find out how Clariness can help you plan your budget for patient recruitment, contact us here.

References

Statista (2019) Clinical trial costs by selected cost component and clinical phase as of 2014 (in U.S. dollars). Statista. Available at: https://www.statista.com/statistics/732896/clinical-trial-costs-by-select-cost-component-and-phase/ [Accessed 07/01/19]
Clariness (2018) Innovation in patient recruitment survey final push. Clariness. Available at: Accessed 07/01/19]
Rose, J (December 2018) ‘How Tech and Data Enable Patient-Centric Clinical Trials’. Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/how-tech-and-data-enable-patient-centric-clinical-trials [Accessed 06/01/19]
Michael J. Fox Foundation Recruitment and Retention Team (December 2018) ‘Using Facebook Ads to Recruit Clinical Study Participants’. Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/using-facebook-ads-recruit-clinical-study-participants[Accessed 05/01/19]
Business Wire (June 2016) ‘eClinicalHealth Announces Successful Results for an Entirely Remote Online Clinical Trial’. Business Wire. Retrieved from: https://www.businesswire.com/news/home/20160621005604/en/eClinicalHealth-Announces-Successful-Results-Remote-Online-Clinical [Accessed 07/01/19]
Michael J. Fox Foundation Recruitment and Retention Team (December 2018) ‘Using Facebook Ads to Recruit Clinical Study Participants’. Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/using-facebook-ads-recruit-clinical-study-participants[Accessed 05/01/19]
Ilancheran, M. (2018). Analyzing the Top Clinical Trial Outsourcing Trends Of 2017. Clinical Leader. Available at: https://www.clinicalleader.com/doc/analyzing-the-top-clinical-trial-outsourcing-trends-of-0001 [Accessed 12 October 2018].
Rose, J (December 2018) ‘How Tech and Data Enable Patient-Centric Clinical Trials’. Applied Clinical Trials. Retrieved from: http://www.appliedclinicaltrialsonline.com/how-tech-and-data-enable-patient-centric-clinical-trials [Accessed 06/01/19]
Statista (2018). Total number of registered clinical studies worldwide since 2000. Statista. Available at: https://www.statista.com/statistics/732997/number-of-registered-clinical-studies-worldwide/[Accessed 12/10/18]