Taking Trial out of Clinical Trials
How can we engage children in long-term clinical trials?
Pediatric Trials Are Challenging
No area of clinical trials is more challenging than pediatric trials. Fear, confusion, and inconvenience, factors that play a role in any clinical trial, are amplified when children are involved. And while much can be done on site to address these, the fact that many trials span numerous geographical locations, facilities, and varying staff competency levels often results in uneven, suboptimal results.
The implications can be serious—lack of engagement, high withdrawal rates, and low patient/parent satisfaction not only raises trial costs and increases the risk of a poor outcome—they can also jeopardize future trials and people’s willingness to participate in them. On average, 85% of clinical trials fail to retain enough patients, with a 30% dropout rate across all clinical trials.
Medical Trials Were Designed For Adults… Not Kids
Whether blood tests or shots, trial participation can be painful for many children.
Children are often unaware what their illness is and why they need to participate in a trial.
Not knowing when a visit is scheduled and what it comprises results in a feeling of powerlessness.
Unable to understand the long-term benefits of the trial, children often feel taken for granted and under-appreciated.
Children participating in a trial are already “sick.” Recurring “doctor’s appointments” only accentuate the problem.
Not only are trial visits uncomfortable, they can often last a long time with no real activity to distract the child.
Framing, Fun, And Friends
Change the way we frame clinical trial participation and the language we use to describe them. No more “doctor visits” but gaming metaphors like “advancing to the next level,” “unlocking rewards,” and earning “power boosts.”
Maintain a steady stream of fun activities during and between trial visits.
Add a social element to help participants feel like they’re part of a chosen few and let them encourage others while receiving it themselves, all while maintaining complete privacy and anonymity.
Education, Engagement & Appreciation
Improving pediatric trial results requires taking a family-centered approach where patients and their caregivers are better informed, more involved and more appreciated, reducing the frustration, fear and anxiety that are commonly related to these trials. The results can be powerful—higher retention, lower trial costs and easier recruitment for future trials.
The key to implementing this approach includes three core components— Education, Engagement and Appreciation. While each one will have a measurable impact on study results, the combination of all three is especially potent.
Collect As Little As Needed, Protect As Much As Possible
Utilize HIPAA-Compliant data storage with monitoring, encryption, logging, and reporting.
Use end-to-end encryption at rest and in transit to ensure that all data sent to and from the user’s device is encrypted so no one can eavesdrop on it.
Apply constant monitoring and threat detection to ensure that sensitive data is protected and that breach attempts are immediately flagged.
Balancing Risk, Reward And Regulation
- Refrain from promising child participants any compensation prior to joining the trial.
Offer rewards with no, or nominal monetary value, such as stickers, points or credits for downloading inexpensive apps.
Combine extrinsic rewards with intrinsic ones, such as collecting points and earning merit badges for helping others.
Provide regular encouragement and appreciation irrespective of visit attendance rates.
Meeting The Regulatory Challenge
Payment for participation in research makes many IRB members nervous because of their concerns about why we pay study participants and whether it could lead to harm.
Undue influence occurs when the compensation or incentive is sufficient to induce prospective participants who otherwise would not enroll to enter studies in which there might be significant risks.
The worry is that people with limited resources are more susceptible to inducements to act against their own best interests, or that, worse, they could be targeted for recruitment because they are easier to influence with smaller sums of money.
The 4 Elements Of Undue Influence
- An offered good…
Of excessive value, making it extremely compelling…
Which encourages participants to exercise poor judgment..
While taking on risk of serious harm.
Source: Emanuel EJ. Undue inducement: nonsense on stilts? Am J Bioeth. 2005;5(5):9-13, W8-W11, W17.