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How to Bust Clinical Trial Myths and Increase Participation
The Problem
In order for the public to benefit
from ground-breaking medical
research, well-attended clinical trials are vital.
Today’s clinical trial regulations often call for large numbers of participants and long
periods of commitment
This makes it more crucial and more difficult than ever to achieve quality
patient participation.
20% of pharmaceutical
companies and CROs report challenges with patient engagement.
Key Questions
What holds potential
participants back from
participating in trials?
To what extent
are their concerns
about clinical trials
misinformed?
How we can assuage these
worries and boost
participation?
Clinical Trials are Dangerous
Potential clinical trial participants may worry
about being kept safe
during the trial.
Myth: Clinical Trials are Dangerous
They may have heard stories about historical
trials in which participants were not
treated with the rigorous ethical
standards of modern trials.
First-time trialparticipants may be particularly
concerned
• Inform patients of the guidelines in place to ensure good clinical practice and to protect their interests.
• Describe the rigorous preclinical screening processes that ensure that drugs are safe for human use and the IRB review that protects patient rights at all stages of the trial.
• Speaking openly to participants will demonstrate that their questions and concerns will be valued throughout the trial process.
• Supply patients with positive testimonials from volunteers who have undergone similar trials.
Solution: Be up-front
Consent = Commitment
At the root of many early patient drop-
outs is a fear of commitment.
Myth: Consent = Commitment
The right to withdraw at any
time may come as a surprise
to potential participants.
By signing up to something as serious
as a clinical trial, patients feel that they are waiving
their rights to change their minds.
• Make potential participants aware of their rights early on in the recruitment process.
• Explain that signing informed consent does not waive patients’ right to drop out at any stage if they feel uncomfortable.
• Be careful to explain if the investigational drugs cannot be stopped without a doctor’s help – encourage participants to express intent to drop out as soon as possible, so they can be assisted as fully as possible.
• Ensure that they’re aware that their consent is an ongoing discussion, rather than a one-off decision.
Solution: Be transparent
Risk of Pain and Side Effects
One of the most important
purposes of clinical trials is to
ascertain the precise benefits and risks of a certain drug.
Myth: Clinical trials have risky side effects
Patients who are already suffering pain or discomfort due to
ongoing illnesses may be hesitant to risk
further pain or side-effects.
Knowing this, many patients
worry about falling prey
to unexpected side-effects.
• When talking potential patients through what they can expect, be sure to explain that the trial has been thoroughly reviewed for any unnecessary discomfort.
• Be honest about likely and worst-case scenarios, and educate potential participants about the likelihood of such risks.
• Using statistics and discussing preclinical screening in detail not only puts things into perspective but also leaves potential participants feeling involved and respected.
Solution: Be specific
There is no personal benefit
Many potential participants believe that even if they don’t face any particular risks, the benefits that they stand
to receive are not substantial enough to justify the time spent.
Myth: Clinical trials offer no personal benefit
Participants may be comfortable with
their current treatment options,
and see no reason to experiment with new
ones.
If potential participants are
managing chronic illnesses, they may not see the wider benefits as being worth the added inconvenience.
• On a personal level, patients stand to benefit from improved disease outcomes and improvements in general health.
• Highlight how during the trial, patients will be monitored closely by experts, and subjected to tests that may be more thorough and insightful those they would receive from their own doctors.
• Impress upon participants that their participation moves vital therapies closer to the people who need them most, improving lives and advancing life sciences.
Solution: Think short and long term
Trials incur personal costs
Patients may be concerned about the personal costs that
participation will incur – in terms of
both time and money.
Myth: Clinical trials incur personal costs
Participants who are already managing
chronic illnesses may not be inclined to take on any further
commitments.
These can range from time taken off work or away from families to regular
transportation costs.
• Explain how trial costs are broken down, and what is covered by the pharmaceutical company.
• Ensure that you discuss any extra costs up front.
• If compensation is offered for time off work or expenses incurred, ensure that the terms and conditions are thoroughly detailed, so that participants can plan and budget.
• Listen to potential patients’ concerns and consider ways to lessen the burden of participation.
• Remember that no issue is too small when it comes to retaining participation.
Solution: Listen closely
Spreading the word
• Maintain open dialogues before, during and after clinical trial phases.
• Connecting with participants via Facebook, Twitter and LinkedIn allows organisations to educate participants in a comprehensive manner.
• Social media also allows participants to reach out to one another, feeling involved and integrated.
• Speaking directly to participants improves the likelihood that they will discuss their positive trial experience with others, leading to still greater numbers of quality volunteers.
Spreading the word
Finding out more
Learn more from mdgroup
• For more guides to patient centricity, visit the mdgroup Life Sciences blog.
• Join us on social media to discuss your own myth-busting tips.