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Protocol-related issues that can impact patient recruitment

Many factors can impact a patient’s decision to take part in a clinical study. But what steps can the industry take to try to improve patient recruitment?  Sometimes, we need to go back to the basics and look to the very beginning of the clinical study process.

If you’re struggling to recruit patients for your clinical study, could the issues be lying in different factors of your protocol design? For example:

The inclusion/exclusion criteria

Did you know that 16% of protocol amendments are due to changes in the inclusion/exclusion criteria? This can lead to complications further down the line due to changes in the population before and after the amendment, so it’s better to get it right the first time.

As these criteria are usually designed by scientists, often they’re only looking at the data to answer their research question, and this doesn’t truly have the patients in mind. It’s important to look beyond proving the hypothesis, and instead ensure that the criteria are actually matching the general patient population that you’re aiming to help.

If your eligibility criteria are too narrow, this can cause longer recruitment times and difficulty finding suitable patients. And while it’s important to consider additional concerns that are specific to your patient population – age, comorbidities, competing therapies, previous treatment and more – this can eliminate many patients who might have the

disease being studied, so it’s crucial to have clear rationale behind these factors.

By gaining insights and finding out as much as possible about your target population, you can design an inclusion/exclusion criteria that correlates with your general patient population, improving recruitment and avoiding complications later in the clinical study.

The clinic visits

It’s important to consider where your clinical study sites will be and the challenges that patients may face trying to get to the clinic. Why? Because the frequency of visits, frequency of medical consultations and the time spent there can all impact patients’ willingness to take part.  Plus, depending on the location, significant travel and time costs may be associated with participation too.

In a study of 5000 responses, it was found that adults generally reported being willing to travel less than 30 minutes and less than 22 miles for urgent care, and about 10% less for routine care. And regardless of age, long travel times that are particularly in urban areas can discourage patients to take part. This just shows how important it is to understand the burden that clinical study participation can have on patients, especially if they’re living in an urban area.

So, by gaining insights from your patient population, you can start to ask important questions regarding clinic visits: can they easily get to the clinic? Do they have a 9-5 job that means they can only visit at certain hours? Will they need food readily available? By learning exactly how many visits are actually necessary, how far they’re willing to travel and any significant costs that may hinder their willingness to take part, you can then make the necessary changes for the protocol. For example, consider placing your study sites close to your patients’ homes, near a transportation hub to make access easier, or offer transportation assistance.

The randomisation process

Would your patients be willing to take part if they were to receive a placebo?

As the randomisation process means patients are at risk of receiving a placebo, this can stop patients from wanting to taking part in a clinical study. It’s not surprising that this can impact their decision; their involvement in a clinical study can take up a lot of time, and to not receive investigational treatment can be disheartening. But we know there’s a reason placebos are used in clinical studies, so how can you overcome this?

  • Explain how placebos work and why they are sometimes used in clinical studies – create patient-friendly materials to make this clear
  • Explain that not all clinical studies use placebo
  • Reassure your patients that they will still receive standard of care
  • If possible, refine the study arms in your protocol - make sure that after a period of time, all participants can start receiving the investigational study drug.

By understanding patients’ concerns at this stage of the clinical study process, you can put procedures in place or make necessary changes to reassure your patients about the randomisation process.

The key message

The solution to all the above is to learn more about your patients – gain their insights and get them involved as early as possible. The most critical stage of the clinical study process is during planning and development. Yet, surprisingly, many research teams don’t involve their patients at this point.

Without gaining patient insights at the protocol design stage, how do you truly know if your study is relevant and applies to your target patient population? Addressing this question is as simple as listening to the patients and ensuring their voice is heard at the protocol design stage.

If you’re looking for support with gaining patient insights and improving clinical study recruitment, get in touch today or download this patient-centric design white paper here.

This blog was originally published here.

19th August 2020



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