A 4 Step Clinical Trial Recruitment Plan to Attain Your Sample Size

Researcher numbers steps for Clinical Trial Recruitment Plan

Recruiting patients for clinical trials can be tedious and difficult, often requiring a lot of time and money.

And last-minute patient recruitment can be a nightmare as well as a poor approach to meet your trial recruitment goal.

Therefore, recruiting successfully for a clinical trial requires a well-managed and thorough clinical trial recruitment plan template.

The more time you reserve to map out the enrollment process, the better equipped you will be to handle unexpected things.
With careful research and advanced planning, you’ll get a better outcome.

Pro Tip: Planning is critical if your study is to be completed on time and within budget. If you’d rather have this step completed for you–you can request a recruitment plan from us that’s tailor-made for your study.

In this post, we’ll outline the steps to create an effective clinical trial recruitment plan.

Step 1- Determine and communicate the benefits of participating in the study

It’s important to take time to research and understand your potential participants. This is a basic rule, yet it is sometimes ignored. Understanding your participants can provide a great deal of insight for how to effectively reach out to your potential patients.

Learn the real reasons that motivate people to join your study. Is it because they are looking for a new treatment? Or is it because they don’t have health insurance and are looking for medical care at no cost?

Next, decide how you’re going to compensate participants. Develop a budget to promote the study, as well as to reimburse the patients for travel and inconvenience. What are the potential fees for advertising? Will you compensate your patients through travel allowances, gift cards, or stipends for their absence at work?

Be transparent and have a well-thought-out plan. This can present your study in a legitimate way and avoid any serious misconceptions. It’s imperative that everything is clear and concise.

Step 2 – Analyze the study design’s impact on recruitment

Determining eligibility criteria and study design are major parts of your trial. These steps are a major undertaking and serve as the core of the study. That being said, there are important things to contemplate as you set out the roadmap for your clinical trial.

Having a clear design and straightforward guidelines for your study will give you a clear understanding of where you may need to make adjustments. And adding the step of appraising the study design’s effect on patient recruitment is an important addition to your patient recruitment plan. If there are parts of your design that will make clinical trial recruitment difficult, consider mending your plan and process.

Step 3 – Create a detailed forecast

For research, everything is about data. Yet when it comes to patient recruitment, planning, or marketing, research staff tend to forget to apply their knowledge of simple math. It’s critical to create metrics during the design phase. This helps you measure your clinical trial recruitment plan against your executed campaign and the associated results.

An Illustration

Your goal is to conduct a clinical trial about type 2 Diabetes and the study requires 100 patients.

It’s been estimated that about 20% of people drop out of a given clinical study. This means you would need: 100 x 120% = 120 people should be screened to achieve enrolment requirements.

Moreover, there are various criteria to fulfill, not just whether the patient is diabetic. For example, viable patients must not have any other pre-existing conditions, must meet maximum or minimum bodyweight requirements, and so on. Once you’ve considered all the stipulations, you should expect a small fraction of screened patients to be eligible for your study.

Projecting for Success

Let’s consider a hypothetical scenario. Assume that in order to gain the 100 participants you need from above, you will pre-screen candidates – either by phone or through online surveys. Those that qualify are then physically screened in a first appointment to determine final eligibility. Of those patients, let’s assume that only 30% of the candidate pool truly fit the requirements to participate in your clinical trial.

Based on the initial figures above, this is:

120 ÷ 30% = 400 people

From a written perspective, this equation reflects the number initially screened to allow for patient dropout, divided by the percentage of patients that will be truly eligible. This equals the number of people that responded to an ad and who are interested and therefore should be initially screened via phone or an online survey in order to glean enough participants.

You should attempt to predict multiple varying scenarios.

If the benefits of enrolling in the study are significant, assume that many patients would be interested in participating. Assume you will need to screen at least 50% more candidates (150% of your initial goal of 400 patients) to achieve enrolment goals: 400 x 1.5 = 600 people that should be screened to achieve participant requirements.

If the benefits are somewhat appealing, double the number: 400 x 2 = 800 people that should be screened.

If the reasons to join are not very appealing, triple the number: 800 x 3 = 2,400 people that should be screened.

As you can see, for every 100 patients needed to complete your type 2 Diabetes study, you’ll need to screen a total number of 626-1,251 potential participants.

Try to work backward and think about the numbers. Anticipate different scenarios and back them up with various solutions. You might not have the answer for everything, but well-prepared metrics will help you arrive at more solid answers and provide invaluable experience on future studies that involve similar patient pools.

A detailed recruitment and enrollment forecast for your study will help you meet your target sample size. If you’d like the number of potential participants forecasted for your study our Due Diligence analysis is backed by empirical data from similar studies we’ve recruited for in the past. You can request one here at no cost.

Step 4 – Create a marketing strategy

How can you get 626 or 1,251 patients? Marketing plays an important role in finding and retaining patients. However, many researchers fail to realize how difficult it is to get people’s attention and thus neglect this step in their patient recruitment plan.

Some Just Don’t Want to Know You

A common mistake in the enrollment process is the failure to factor in the number of non-responses during clinical study recruitment. For instance, let’s say you need 800 patients for your trial. You have access to a mailing list of 1,000 patients through a partner who’s able to send an email about the study. Can you brush it off and move on to the next task?

No; the work is not done yet.

Studies show the average email open rate is about 20%. This means you’ll be missing out on informing 800 people from that mailing list because they never read the email and therefore, are completely unaware of your trial.

What about the 20% who open the email? Assuming the benefits of participating in the study are very appealing, what is the major factor that will fail to convert them?

The Major Factor to Gain Conversions

The answer to the question above is simple: the email’s content. The information sent in the email body can make a huge difference.

Stick to this rule: write really good content.

Put a lot of effort into writing the ads. Think about the positives of participating. (Remember, it needs to adhere to the principles of GCP and be approved by an ethics committee.) Your content should be easy to read, easy to understand, answer the right questions, and address any potential concerns.

New Opportunities

Technology advancement has allowed us to reach out to more people than ever before. Make sure you leverage all media outlets when planning your clinical trial recruitment. Traditional methods – such as newspaper, TV, and radio advertising have declined in reach and cost-effectiveness over the last decade.

Social media advertising, search advertising, email campaigns, and niche-connected websites are great places to find participants for your trial. You can also reach out to certain patient advocacy groups, university student organizations, or work with relevant health professionals.

Estimate the Numbers

Whichever medium you choose to promote your study, it’s essential to estimate the numbers based on prior experiences. Instead of making guesses, speak to another researcher who has used a similar method before and utilize information from their results. Remember that all strategies take time to get off and running, so plan to start early.

Advanced research, setting clear goals, and a little extra effort can help the recruitment plan phase go a long way. Paying close attention to the trial design is vital to the success of any study.

Ready to take the next step in planning your clinical trial recruitment? These guides will help:

  1. Does Social Media Recruitment Make Sense for My Clinical Trial?
  2. The Volunteer-Researcher Relationship
  3. Beginner’s Guide to Using Facebook Advertising for Patient Recruitment

If you’re looking for more insight on how to better recruit patients for your clinical trial contact Trialfacts today to find out how we can help you fulfill your recruitment goals.

Get a free, no obligation recruitment plan:

We’ll undergo our due diligence process and determine how many patients we can provide for your study (guaranteed).

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