Clinical trial accrual

We found that there were competing trials, eligibility or patient considerations, logistical issues, funding concerns, and premature closure. We know that clinical trials don't enroll particularly well in certain areas.

But, this was the first time in a children's clinical trial that we had some low numbers, so we were really surprised by it. It just shows you that we're dealing with a little bit of a different patient population, as we can see, because they're AYA patients, and many of the adolescents are potentially emancipated.

Therefore, they don't have that parent advocate, who is reading the fine line, who is looking at why this trial is potentially a good thing for their child. They don't have that support network. Therefore, we were excited to get this published. For soft tissue sarcoma, this is the first time in the United States that a medical oncology cooperative group and a pediatric oncology group have come together to design a trial to answer a question.

As importantly, the other medical oncology groups that weren't involved with the execution of the trial itself were interested enough to the fact that the accrual was low that they got on board with doing the survey, and reaching out and finding out why we weren't getting AYAs enrolled and it affirms the issue that AYA patients have so many challenges.

Many of them are young parents; they're not financially secure yet, and they just need the treatment. They don't have time to get enrolled in clinical trials and all that goes along with it. Nothing surprised us. However, we really hadn't ever been able to show it; it had been very much sort of "level five, ask the expert," on why these patients are challenged.

That's the beauty of this; through this survey, we actually were able to scientifically document these challenges rather than just know them because of the empiricism of being in the clinics with the patients. You can drill down on the challenges with the programs themselves, because, again, [there are challenges such as] funding within the institution, who is going to support it, is it going to come from the coffers of the pediatric group or the adult group, etc.

There are lots of challenges around getting these programs up and running, which is sort of a reflection on the overall paradigm that all of health care, whether it's in a clinical trial domain, or the just the day-to-day experience of patient care that the AYA patients, at least in oncology, fall between the cracks. Be very sensitive to the challenges facing AYA patients, and by convention that is defined as 15 to 39 years. The primary reported barriers included perceived lack of patient interest, lack of trial awareness, and logistical barriers.

Emailing trial investigators directly was the preferred method of trial referral. Conclusion: Our respondents valued trial participation for their patients but found it difficult to manage. Further research is needed regarding how to increase the likelihood that patients are presented with appropriate trial options. Abstract Background: Only a small proportion of patients with cancer enroll onto clinical trials.

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