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.