How to Combat Barriers to Enrollment in Clinical Trials
A widespread challenge within the clinical trials industry is the recruitment,
enrollment and retention of patients. This is largely due to the multiple
types of barriers that prevent patients from enrolling in a study - these
barriers need to be overcome through innovative and patient-centric
approaches. Financial barriers include having to pay for certain routine care
costs such as copayments, coinsurance, or deductibles, time away from work for
clinical visits and travel to the clinical trial site, and having to pay for
lodging, meals, childcare, and transportation required for clinical trial
participation. Patients often feel concerned about potential adverse reactions
to the investigational agent, which may lead to unpredictable healthcare
expenses. On top of these barriers is the stress that comes along with trying
to find a clinical trial that fits a patient's needs while deciphering the
medical jargon that describes the study on sites like ClinicalTrials.gov. One
way to improve recruitment and retention in clinical trials and mitigate these
already abundant stressors is to make the information about the trials more
readily available, easier to understand, and to provide clear instructions on
next steps.
Clinical trial listings are most effectively understood by patients when the
trial information is presented in a simple and easily digestible way. Here at
ClinicalConnection.com, we have amassed patient engagement data on over 50,000
clinical trials that we have listed on our website in the past 20 years. Below
are a few tips on how to make your own study listings more engaging and
understandable, which will yield improved patient recruitment and retention
rates:
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Display the information about the trial using bulleted lists instead of
paragraphs of text to make the information look clean, organized, and
overall, feel less overwhelming. Bulleted lists also greatly aid
comprehension and reduce the likelihood of a potential study participant
missing key details.
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Be clear about how the trial will be conducted and what will be expected of
the study participant. Include key details such as:
- number and location of office visits
- duration of the trial
- what procedures will be involved
- information about compensation for time and travel
- easily understood inclusion/exclusion criteria
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any other information you think a patient would want to know before they
indicate that they are interested in participating in the trial.
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Replace terms like "...randomized, double-blind, placebo-controlled, Phase 2
study, evaluating the efficacy and safety of the investigational
medication..." with wording such as "...clinical research study of an
investigational medication for..." to aid understanding.
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Integrating inclusive and relevant images into your study posting increases
engagement and improves the likelihood that patients will seek to
participate. Make sure to have "alt tags" and "alt descriptions" in the code
for these images so that people with screen readers can also get the
information contained within the images. This is important for maintaining
compliance with the Americans with Disabilities Act (ADA).
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Include a map of your site location and directions on how to get to the site
for office visits.
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Provide a clear call-to-action. Let patients know exactly what they should
do if they are interested in learning more about the study.
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IRB-approved materials are always preferred when listing trials online if
they meet the criteria listed above but not always necessary. The FDA has
mandated that as long as only general information regarding the study (study
name, summary, inclusion/exclusion criteria, and clinic contact information)
is posted online it does not need to be IRB-approved. If you choose to post
risk and/or benefit information regarding participation in the clinical
trial then IRB approval is necessary.
By removing the guesswork,
uneasiness, and fear that may come with trying to understand what exactly a
patient must do to be a part of a trial, patients can have a more stress-free
experience while looking for clinical trial opportunities. This way, patients
are making an informed decision and can evaluate if they are able to commit to
the entirety of the trial before they begin the screening process. When patients feel informed and
educated about their opportunities to
participate in clinical trials, they can enroll in a trial with little to no
hesitation, allowing you to make patient recruitment more efficient.
We hope this information is helpful for you as you list your clinical trials
online. If you have additional questions or would like for us to help you
optimize your clinical trial listings, please create an investigator account
and post your first clinical trial at https://www.clinicalconnection.com/clinic-admin/study-center-join. By posting your trials with us, you can easily and quickly inform patients
of everything they need to know about your clinical trial in a
patient-centered and easy-to-understand way.
Each
clinical trial listed on ClinicalConnection.com is reviewed by our trained
staff to optimize patient engagement and recruitment results – create your account today!