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Improving participation in clinical trials of novel therapies: going back to basics

Chan-Bum Choi1, Sang-Cheol Bae2, Samar Gupta3

  • 1Department of Rheumatology, Hanyang University Hospital for Rheumatic Diseases, Seoul, Republic of Korea; Department of Aging, Brigham and Women's Hospital, Boston, MA, USA; Section of Rheumatology, VA Healthcare System, Boston, MA, USA.

Rheumatic Diseases Clinics of North America
|July 19, 2014
PubMed

Insights

Clinical trial enrollment for systemic lupus erythematosus (SLE) is challenging due to complex protocols and strict criteria. Addressing these factors is crucial for advancing SLE research and therapy development.

Area of Science:

  • Rheumatology
  • Clinical Research
  • Immunology

Background:

  • Clinical trials face widespread enrollment difficulties.
  • Systemic lupus erythematosus (SLE) trials are reportedly experiencing similar enrollment challenges.
  • Several general factors contribute to declining clinical trial participation.

Purpose of the Study:

  • To identify and discuss factors hindering participant enrollment in clinical trials for novel systemic lupus erythematosus (SLE) therapies.
  • To provide insights into the specific challenges faced by SLE clinical research.

Main Methods:

  • Review of general trends in clinical trial enrollment.
  • Analysis of anecdotal reports concerning SLE trials.
  • Identification of common barriers to participant recruitment in medical research.

Main Results:

  • Growth of the contract research industry impacts trial logistics.
  • Increased regulatory oversight and concerns about research integrity pose challenges.
  • Complex trial protocols and restrictive eligibility criteria deter potential participants.
  • Participant apprehension regarding disease flares may influence enrollment decisions in SLE studies.

Conclusions:

  • Enrollment challenges in SLE clinical trials are multifactorial.
  • Addressing participant burden and trial complexity is essential for improving recruitment.
  • Strategies to mitigate risks and enhance participant safety may facilitate SLE trial participation.
Keywords:
EnrollmentRandomized clinical trialsRetentionSystemic lupus erythematosus

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