(1202) Access to Clinical Trials for Adolescents and Young Adults with Hodgkin and Non-hodgkin Lymphoma: A Meta-research Analysis

Objectives:

Background: Adolescents and young adults (AYA) patients between ages 15-39 comprise the largest age group affected by Hodgkin lymphoma (HL) and Non-Hodgkin lymphoma (NHL). Despite advancements in treatment and increase in survival rates, AYAs remain vulnerable, as they continue to lag behind pediatric patients in mortality and survival trends. Because dedicated research efforts are lacking, there is no single treatment approach that is considered a standard of care for AYA patients. With very few AYA patients with HL and NHL enrolled in clinical trials, they are often treated as either pediatric or adult patients. AYA patients have unique physiologic and psychological profiles compared to their pediatric and adult counterparts and therefore have unmet needs from standard pediatric or adult regimens.

Objective: To identify the main challenges AYAs face currently in accessing clinical trials for lymphoma treatment and to analyze the number of clinical trials available for AYA patients with HL and HNL.

Methods: A meta-analysis of clinical trials posted on Clinicaltrials.gov was conducted using PRISMA (Preferred Reporting Items for Systematic Review and Meta-analysis) statement and guidelines. Trials were included for analysis if they were early- or late-phase (i.e., not a postmarketing authorization study), had a study start date within the last 10 years (2013-2023), and recruiting patients with HL and NHL. Clinical trial studies were split into three groups: pediatric (upper inclusion age limit < 18), transitional (lower limit < 18 and upper limit >18), and adult (lower inclusion age limit >18). We narrowed our search with AYA specific clinical trials (lower inclusion age limit >15 and upper inclusion age limit < 39). Using the trials that were narrowed, we will identify whether the number of new trials for AYAs have increased, decreased, or stayed the same throughout the decade.

A systematic literature review was also conducted to assess the barriers for AYA patients with HL and NHL in accessing clinical trials. PubMed MEDLINE, Web of Science, Scopus, and PsycINFO databases were searched to find relevant studies. The keywords were tailored to each database, such as the use of Medical Subject Heading (MeSH) terms in PubMed. Studies were eligible for inclusion if they were written in English, included quantitative or qualitative data analysis, and examined barriers for AYA patients with HL and NHL in clinical trial enrollment, and the target population was AYAs with HL or NHL.

Results: Data abstraction for the systematic literature review and analysis of clinical trials from Clinicaltrials.gov are currently in progress.

Conclusions: N/A