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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 pervasive worries to boost participation?
Myth: Clinical Trials are Dangerous
Myth: Clinical trials are dangerous
• Potential clinical trial participants may worry about being kept safe during the
trial.
• First-time trial participants may be particularly concerned
• They may have heard stories about historical trials in which participants were
not treated with the rigorous ethical standards of modern trials.
Solution: Be Transparent
• 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.
Myth: Consent = Commitment
Myth: Consent = Commitment
• At the root of many early patient drop-outs is a fear of commitment.
• By signing up to something as serious as a clinical trial, patients feel that they
are waiving their rights to change their minds.
• While the importance of voluntary participation and fully informed consent is
obvious for medical professionals, the right to withdraw at any time may come
as a surprise to potential participants.
Solution: Start Early
• 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.
Myth: Risk of Pain and Side Effects
Myth: Clinical trials have risky side-effects
• One of the most important purposes of clinical trials is to ascertain the precise
benefits and risks of a certain drug.
• Knowing this, many patients worry about falling prey to unexpected side-
effects.
• Patients who are already suffering pain or discomfort due to ongoing illnesses
may be hesitant to risk further pain or side-effects.
Solution: Be Up-Front
• 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.
Myth: There is no Personal Benefit
Myth: Participants rarely benefit from trials
• Many potential participants believe that even if they don’t face any particular
risks in a clinical trial, the benefits that they stand to receive are not substantial
enough to justify the time spent.
• If potential participants are managing chronic illnesses, they may not see the
wider benefits as being worth the added inconvenience.
• Participants may be comfortable with their current treatment options, and see
no reason to experiment with new ones.
Solution: Highlight the perks
• 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.
Myth: Trials Incur Personal Costs
Myth: Clinical trials incur personal costs
• Patients may be concerned about the personal costs that participation will
incur – in terms of both time and money.
• These can range from time taken off work or away from families to regular
transportation costs.
• Participants who are managing chronic illnesses may be unable or unwilling to
spend extra time and money on the trial process.
Solution: Listen closely
• 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.
Spreading the Word
How to share this myth-busting information
• 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.
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 - mdgroup

  • 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 pervasive worries to boost participation?
  • 4. Myth: Clinical Trials are Dangerous
  • 5. Myth: Clinical trials are dangerous • Potential clinical trial participants may worry about being kept safe during the trial. • First-time trial participants may be particularly concerned • They may have heard stories about historical trials in which participants were not treated with the rigorous ethical standards of modern trials.
  • 6. Solution: Be Transparent • 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.
  • 7. Myth: Consent = Commitment
  • 8. Myth: Consent = Commitment • At the root of many early patient drop-outs is a fear of commitment. • By signing up to something as serious as a clinical trial, patients feel that they are waiving their rights to change their minds. • While the importance of voluntary participation and fully informed consent is obvious for medical professionals, the right to withdraw at any time may come as a surprise to potential participants.
  • 9. Solution: Start Early • 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.
  • 10. Myth: Risk of Pain and Side Effects
  • 11. Myth: Clinical trials have risky side-effects • One of the most important purposes of clinical trials is to ascertain the precise benefits and risks of a certain drug. • Knowing this, many patients worry about falling prey to unexpected side- effects. • Patients who are already suffering pain or discomfort due to ongoing illnesses may be hesitant to risk further pain or side-effects.
  • 12. Solution: Be Up-Front • 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.
  • 13. Myth: There is no Personal Benefit
  • 14. Myth: Participants rarely benefit from trials • Many potential participants believe that even if they don’t face any particular risks in a clinical trial, the benefits that they stand to receive are not substantial enough to justify the time spent. • If potential participants are managing chronic illnesses, they may not see the wider benefits as being worth the added inconvenience. • Participants may be comfortable with their current treatment options, and see no reason to experiment with new ones.
  • 15. Solution: Highlight the perks • 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.
  • 16. Myth: Trials Incur Personal Costs
  • 17. Myth: Clinical trials incur personal costs • Patients may be concerned about the personal costs that participation will incur – in terms of both time and money. • These can range from time taken off work or away from families to regular transportation costs. • Participants who are managing chronic illnesses may be unable or unwilling to spend extra time and money on the trial process.
  • 18. Solution: Listen closely • 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.
  • 20. How to share this myth-busting information • 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.
  • 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.