279 INCLUSION OF OLDER PATIENTS IN CLINICAL TRIALS: A REVIEW OF A SINGLE, HIGH IMPACT, MEDICAL JOURNAL OVER A 2-YEAR PERIOD

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Abstract Background Older patients have the highest rates of multimorbidity and prescription drug use. Despite this, previous research has found that these patients are not well represented in Randomised-Control Trials (RCTs), limiting external validity. In recent years many guidelines have been issued to help facilitate the inclusion of older patients in RCTs. We aimed to explore the inclusion of older patients in recent RCTs publications. Methods A single, high impact, medical journal was systematically reviewed, with all full text publications between March 2019 and March 2021 being screened. All adult, Phase III, RCTs were selected. The age descriptors of controls were extracted, in addition to information on eligibility criteria that could lead to exclusion based on age, comorbidity, or cognition. Results Of 123 RCT publications, the mean age was ≥65 in 42.1% and ≥75 in 8.3%, while the 75th centile age was ≥65 in 72% and ≥75 in 25%. An explicit capacity requirement was present in 41.5% and those with cognitive impairment were excluded in 15.4%. Eligibility determined at the discretion of the investigator and a life-expectancy exclusion criteria were present in 33.3% and 36.6%, respectively. A maximum age limit was present in 18.7%. No RCTs excluded on the basis of polypharmacy. The mean/75th centile age differed significantly by speciality (p<0.05), oldest in cardiovascular and medical RCTs. Having a maximum age limit was significantly associated with a lower mean/75th centile age (p<0.01), while having a life-expectancy exclusion criteria was associated with a higher mean/75th centile age (p<0.05). The age did not differ significantly between pre/post-COVID-19 RCTs, or for other eligibility criteria studied. Conclusion While those ≥65 were well represented, those ≥75 were not. Eligibility criteria that could potentially lead to exclusion based on age, comorbidity, or cognition were also common, although the majority did not significantly affect age.

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