Frontiers in Myeloma: Barriers to Clinical Trial Participation in Multiple Myeloma

Background

Clinical trials provide an opportunity for patients to access new treatments and receive expert medical care, which potentially improves the quality and length of their lives. By participating in trials, patients help further medical research, thereby improving treatments for others. However, patient participation in trials remains low due to multifaceted barriers related to trial design, patient factors, and attitudes of healthcare professionals.

Frontiers in Myeloma (FIM) is a multistakeholder initiative led by an international group of myeloma patient advocacy thought leaders who work to elucidate and describe the most pressing equality and equity issues that impact patients with myeloma. This study identified current barriers to clinical trial access in multiple myeloma (MM) across different jurisdictions and populations and provided practical recommendations for stakeholders to help facilitate access and participation.

Methods

Clinical trial registries (WHO, ClinicalTrials.gov, and EUCTR) were searched for clinical trials in MM that were registered between 2011 and 2021. Data were analyzed to determine the countries in which MM clinical trials recruited patients and how many trials took place. A systematic literature review was conducted in line with PRISMA recommendations to identify barriers and facilitators to enrollment in MM clinical trials. Three electronic databases were searched since their inception: MEDLINE, Embase, and APA PsycInfo.

Primary research was conducted through stakeholder interviews to identify barriers and initiate discussion on the types of recommendations and feasibility of their implementation. Interview questions were based on preliminary findings from the literature review; questions assessed participants' involvement in MM clinical trials and their views on the barriers and facilitators to patient enrollment. Key stakeholders involved in MM trials, including patients, patient advocates, clinicians, researchers, and clinical nurses, were identified and interviewed via Zoom.

Findings from the primary research were used to develop recommendations for stakeholders to address the identified barriers to clinical trial access and participation for patients with MM.

Results

Clinical trial analysis for regional data identified 3141 MM trials. Most trials were conducted in the US (61%), followed by Western Europe (24%), Southern Europe (14%), and East Asia (13%). Geographic regions in which the fewest trials were conducted were South Asia (<1%) and Africa (<1%).

Various barriers were identified in the systematic literature review, including clinical, patient, structural, and physical barriers. Stringent eligibility criteria and lack of geographic access were the most frequent barriers reported.

Funding: This study was sponsored byGSK. Editorial support was provided by to Nucleus Global, an Inizio Company and funded by GSK.

Kaiser:J&J/Janssen: Consultancy, Honoraria, Research Funding; Pfizer: Consultancy, Honoraria; GSK: Consultancy; Pfizer: Consultancy, Honoraria; Roche: Consultancy; Sanofi: Consultancy; BMS/Celgene: Consultancy, Honoraria, Research Funding; Regeneron: Consultancy; Poolbeg: Consultancy, Honoraria. O'Neill:GSK plc: Current Employment, Current equity holder in publicly-traded company. Biru:Sanofi: Other: served on the advisory board of OncoCollective.