Clinical drug trials in general practice: how well are external validity issues reported?

Area of Science:

• Clinical Research
• Pharmaceutical Medicine
• General Practice

Background:

• Assessing the external validity of clinical trial results is essential for determining their relevance to patient care.
• Generalizability of drug trial findings to real-world settings, particularly general practice, is a key concern for clinicians and guideline developers.

Purpose of the Study:

• To evaluate the extent to which published articles from drug trials conducted in Norwegian general practice report information relevant to external validity.
• To identify common omissions in reporting that may impede the assessment of generalizability.

Main Methods:

• A cohort of 196 drug trials in Norwegian general practice was identified.
• 134 published journal articles reporting trial results (2000-2015) were analyzed.
• Reporting of clinical setting, patient selection, co-morbidity, co-medication, ethnicity, primary outcome, and adverse events was assessed.

Main Results:

• Only 22% of articles reported the clinical setting; 46% reported the number of patients screened.
• Patient co-morbidity was reported in 40%, co-medication in 20%, and race/ethnicity in 58%.
• Surrogate outcomes were used in 45% of trials, while clinical and patient-reported outcomes were used less frequently.

Conclusions:

• Incomplete reporting of clinical setting, patient selection, and participant co-morbidity/co-medication is common in published drug trial results from general practice.
• These reporting deficiencies limit the ability of readers to assess the generalizability of trial findings.
• This lack of information can complicate clinical decision-making and the development of evidence-based guidelines.