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Accepted for/Published in: JMIR Cancer

Date Submitted: Aug 29, 2021
Open Peer Review Period: Aug 29, 2021 - Oct 24, 2021
Date Accepted: Mar 26, 2022
Date Submitted to PubMed: Apr 22, 2022
(closed for review but you can still tweet)

The final, peer-reviewed published version of this preprint can be found here:

Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants

Mudaranthakam DP, Gajewski B, Krebill H, Coulter J, Springer M, Calhoun E, Hughes D, Mayo M, Doolittle G

Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants

JMIR Cancer 2022;8(2):e33240

DOI: 10.2196/33240

PMID: 35451964

PMCID: 9073606

Barriers to clinical trial participation: a comparative study between rural and urban participants

  • Dinesh Pal Mudaranthakam; 
  • Byron Gajewski; 
  • Hope Krebill; 
  • James Coulter; 
  • Michelle Springer; 
  • Elizabeth Calhoun; 
  • Dorothy Hughes; 
  • Matthew Mayo; 
  • Gary Doolittle

ABSTRACT

Background:

The National Clinical Trials Network program conducts phase 2 or phase 3 treatment trials across all National Cancer Institute designated cancer centers. Participant accrual across these clinical trials is a critical factor in deciding the success of these clinical trials. Cancer centers which cater to rural populations, such as The University of Kansas Cancer Center, have an additional responsibility to ensure rural residents have access and are well represented across these studies.

Objective:

There is scant data available regarding the factors that act as barriers to the accrual of rural residents in these clinical trials. This study aims to utilize electronic screening logs that were used to gather patient data at several participating sites in the KU Cancer Center catchment area.

Methods:

Screening log data will be used to assess what clinical trial participation barriers are faced by these patients. Additionally, the differences in clinical trial participation barriers were compared between rural and urban participating sites.

Results:

Analysis revealed that the hospital residential category, defined as whether the hospital was in an urban or rural setting, had a medium effect on enrollment of patients in breast cancer and lung cancer trials (D=0.7). Additionally, the hospital residential category had a medium effect on the proportion of recurrent lung cancer cases at the time of screening (D=0.6).

Conclusions:

In consideration of the financially hostile nature of cancer treatment, geographical and transportation barriers, clinical trials are uniquely positioned to alleviate that burden where appropriate. However, these options can be far less feasible for patients in rural settings. Since the proportion of cancer patients who are eligible for a clinical trial is already limited by the stringent eligibility criteria required of such a complex disease, improving accessibility for rural patients should be a greater focus in health policy. Clinical Trial: The University of Kansas Medical Center granted approval under a central IRB with reliance by the other institutions (STUDY00002341).


 Citation

Please cite as:

Mudaranthakam DP, Gajewski B, Krebill H, Coulter J, Springer M, Calhoun E, Hughes D, Mayo M, Doolittle G

Barriers to Clinical Trial Participation: Comparative Study Between Rural and Urban Participants

JMIR Cancer 2022;8(2):e33240

DOI: 10.2196/33240

PMID: 35451964

PMCID: 9073606

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