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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 trial
participants 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.

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How to Bust Clinical Trial Myths and Increase Participation

  • 1. How to Bust Clinical Trial Myths and Increase Participation
  • 2. 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.
  • 3. 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?
  • 5. 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 trial participants may be particularly concerned
  • 6. • 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
  • 8. 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.
  • 9. • 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
  • 10. Risk of Pain and Side Effects
  • 11. 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.
  • 12. • 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
  • 13. There is no personal benefit
  • 14. 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.
  • 15. • 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
  • 17. 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.
  • 18. • 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
  • 20. • 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
  • 22. 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.