An estimated 80% of clinical trials do not meet their patient enrollment goals1. Without enough patients to fill the
trial, sponsors don’t have enough data to file for commercial approval. Study sites fail to meet enrollment goals for several reasons: competing studies mean patients are in demand, sites have limited timelines, awareness for the study may be low, or the protocol may be overly complex.
If you wait until enrollment rates are too far behind to augment recruitment, you’re already too late—you won’t have enough time to gain the approvals you need to deploy a recruitment campaign. Set your study up for enrollment success (and save time and money) by
preparing a risk mitigation strategy in advance and deploying it only when and where it’s needed.
What is a Risk Mitigation Strategy?
With a risk mitigation approach, you plan for and develop all components of a recruitment program, but only deploy that program when and where it is needed. By investing time and planning resources up front, a risk mitigation strategy gives you options for the future in order to set study teams up for success should they require an additional stream of patients.
While gaining regulatory approvals for study materials also develop and, when necessary, gain advanced approvals on a patient recruitment program that includes digital campaign elements like a study website and pre-screener, physician referral network setup, and/or site support solutions. Then, should a site or country need additional support, you’ll be prepared to implement a recruitment campaign immediately and have a higher chance of meeting your site or country randomization goals on time.
Determining What Countries to Include in Your Risk Mitigation Strategy
It’s unlikely that every country participating in your study will fall behind in enrollment, but you likely won’t know what you’ll need and where you’ll need it until it’s too late: it takes time and resources to prepare for and get an effective patient recruitment campaign developed and approved. You must be strategic in narrowing down which countries you plan to support.
When determining which countries to include in the patient recruitment campaign, ask yourself the following questions about each country on the list:
- Are there enough patients and sites to support the proposed level of effort?
- Does the country’s legal or regulatory body allow the materials and advertising that you plan to develop? Physician referral network? Local site support? Community outreach?
- Are materials and advertising types allowed by the sponsor?
- Will local country managers support patient recruitment efforts?
After you have answered, “yes” to these questions, you should begin planning your campaign materials with a focus on your target audience.
Preparing for a Global Campaign
For a risk mitigation plan to be successful materials must be developed and ready to go should a trigger be activated. This means you not only plan for the materials your campaigns will require you also validate and culturally adapt materials so that they are ready to be printed and shipped should a country need support.
Once you have narrowed down your country list develop a patient recruitment campaign that resonates with local audiences without creating multiple unique campaigns or oversimplifying with one campaign that won’t resonate globally.
First, gather global insights to understand cultural nuances and determine if there are enough commonalities in patient populations and motivations to support a single campaign or whether separate, localized concepts are necessary for any of your supported countries.
Once you have developed a concept for your primary campaign, you should validate the concept through quantitative testing and then
adapt and translate it for each country.
When to Deploy Your Patient Recruitment Campaign
In order to implement your campaign at the most efficient time, you must identify key enrollment milestones or “triggers” that indicate a ‘point of no return’ when a patient recruitment campaign can no longer get enrollment back on track. Evaluate the study projections versus actual randomizations and understand what’s possible with your recruitment campaign. Understand that milestones can’t be “one size fits all” and should be calculated and adjusted per country, based on the country’s number of sites and target randomization goals.
Potential data points to consider when developing milestones:
- Percent of sites activated and location of sites needing support
- Screening rates (actual vs projected)
- Screen failure rates (actual vs anticipated)
- Early termination rates
Once you have established your milestone, determine if your sites are tracking to meet their enrollment goals. If your sites are tracking to meet their goals, then maintain current enrollment support with site support materials. If they are not tracking, then you will need to implement the already-approved patient recruitment campaign.
Key Takeaways:
- Investment up front to develop and approve outreach materials preserves the option to deploy a patient recruitment campaign in time to meet your enrollment targets
- Upfront insights and understanding your global audience enable patient recruitment campaigns that will resonate locally without over-investing
- Carefully identify key enrollment milestones that indicate when to deploy your recruitment campaign so that you meet your enrollment goals on time
References
Fassbender, M. (2019, June 20). Patient recruitment services market to reach $5.3bn by 2030.
Retrieved from https://www.outsourcing-pharma.com/Article/2019/06/20/Patient-recruitment-services-market-to-reach-5.3bn-by-2030
