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Abstract
Background Pharmacogenetic studies analyse the variability of drug response; patient-reported outcome (PRO) measures complement traditional measures. Pharmacoeconomic studies tell us the efficiency of different therapeutic alternatives.
Purpose To evaluate the use of PRO measures, including health-related quality of life questionnaires (HRQoLQ), and the frequency of inclusion of pharmacogenetics studies and economic variables in the design of clinical trials (CT) and observational studies (ST). For CT, the quality of the study design was also measured.
Materials and Methods Observational study of CT and ST approved by a Clinical Research Ethics Committee (active between Jan/2008–May/2012). Information recorded: medical specialty, pathology, methodological quality (Jadad scale: 0–5), inclusion of PRO, HRQoLQ, pharmacogenetics studies (collection or not of human biological samples) and economic variables (use of healthcare resources and/or indirect costs defined as the number of days lost due to sick leave of patients and caregivers). The information was systematically collected by 2 reviewers and checked by a third if discrepancies arose.
Results Ninety-four protocols (79CTs, 15ST) were analysed; 51 included PRO measures (54.3%), 44 CT (38 had HRQoLQ) and 7 ST (6 had HRQoLQ). Analysis by area showed PRO measures were most commonly studied in: endocrinology, neurology, digestive diseases and cardiology. The average quality score was 3.04. 31 studies incorporated pharmacogenetics studies, which were less frequent before 2010 than after (45.3% versus 65.4%). In 50% of the pharmacogenetics studies the storage of collected human biological material in biobanks was planned with the objective of conducting studies about drugs responses according to the genetic endowment. Twenty (25%) CTs and two (18.2%) STs included economic variables.
Conclusions The evaluation of economic variables in CTs and STs was low. More than half of the protocols included PRO measures, reflecting the importance of these parameters. Increasing knowledge of pharmacogenetics has resulted in a higher inclusion of these studies in more recent CTs. The average quality for the CT exceeded the value 3, indicating that studies analysed were of reasonable quality.
No conflict of interest.