Conflicts of Interest in Guideline Development: What to Do When Everyone Has a Conflict

Establishing formal mechanisms to keep relationships visible over time can serve as helpful reminders to guideline leaders and team members. Such mechanisms could include requiring a verbal acknowledgement of relevant relationships at the start of each meeting—focused on those relevant to the day’s agenda—and explicitly linking industry relationships to specific commercial products (e.g., drug, device or vaccine). The group can then decide, through discussion or vote, whether to recuse the member from the discussion that day.

LN Guideline?

Will we ever have a clinical practice guideline for lupus nephritis?

Nephritis is one of the most dreaded complications of lupus, but it is also an area with a wealth of high-quality evidence. So why doesn’t the ACR have a clinical practice guideline for its management? It’s not for want of trying, but the process has been hampered by the difficulty of forming a majority-unconflicted core team. In the field of lupus nephritis, virtually all trials are industry funded, making it virtually impossible to identify unconflicted content experts.

How can the ACR shepherd this much-needed project forward and maintain its high standard of scientific integrity? To start with, the core team, literature review team, voting panel and, importantly, the principal investigator, could comprise individuals who are experts in the field of lupus, even if not specifically focused on lupus nephritis. The group could also include experts in guideline development, outcomes, clinical trials methodology and epidemiology.

Lupus nephritis trialists not directly involved in guideline development could potentially be used as outside consultants.⁸ Such consultants could be asked to identify clinical questions they consider critical for the literature review and could potentially lecture on such topics as outcome measures in lupus nephritis clinical trials.

Managing COI over the long process of guideline development will be key, including recusal of members from deliberating, drafting or voting on specific recommendations if necessary.

Where the evidence is strong, it will stand on its own two feet. Where it is weak or unclear, it will benefit from review by fresh and unconflicted eyes.

Anne R. Bass, MD, is a rheumatologist at the Hospital for Special Surgery in New York. She is currently the chair of the ACR’s Committee on Ethics & Conflict of Interest, and she recently rotated off of the ACR Board of Directors. Dr. Bass is the principal investigator of the 2022 ACR Guideline for Vaccinations in Patients with Rheumatic and Musculoskeletal Diseases.