WHAT IS ALREADY KNOWN ABOUT THIS SUBJECT• Current knowledge is based on practical experience. This paper presents the first novel, quantitative and qualitative view on the efficacy of the sponsor query system widely applied in the pharmaceutical industry, used for quality control purposes by data management for clinical data. WHAT THIS STUDY ADDS• This study presents a structured view on the process of clinical data management and sponsor queries, the efficacy and cost effectiveness of sponsor queries and dual data entry and the conclusion to advocate a more evidence-based approach to clinical data validation. AIMProcedures for verification of data from clinical studies are intended to maintain reliability for clinical trial results. Guidelines or legislations relating to clinical data management are of limited value and no study has yet demonstrated its effectiveness. METHODSponsor queries and dual entry procedures from one CRO on three different phase I trials are analysed on content, impact and cost. RESULTIn this study, sponsor queries and dual entry procedures proved time and cost inefficient in detecting data discrepancies. CONCLUSIONWe advocate a more evidence-based approach for enhancing data integrity throughout the process of clinical data management.

Good clinical practice (GCP) guidelines should always be implemented and obeyed in clinical interventional studies. In this mini-review, we will address several burning questions relating to GCP in a concise ‘frequently asked questions’ format. While compliance to current rules and regulations is our mission, we also wish to play devil's advocate attempting to translate the rules into sizeable chunks using a high dose of common sense.

Randomised controlled clinical trials (RCTs) offer a unique opportunity to obtain controlled efficacy and safety data to support clinical decisions. However, most RCT reporting has a stronger focus on efficacy rather than safety. This study aimed to identify the safety profile of both probiotic and drug interventions in irritable bowel syndrome (IBS). In connection to this paper, an accompanying paper was published in which a meta-analysis was conducted to evaluate the efficacy of probiotic interventions compared to that of drug interventions in IBS. Together, these two studies provide a first assessment regarding the feasibility to determine a burden to benefit ratio for both probiotic and drug interventions in IBS. RCTs including participants (>18 years old) with IBS and comparing probiotic or drugs interventions with control groups were identified by a systematic search of MEDLINE (January 2015 – Jan 2021). Reported safety profiles in drug studies were completer and more detailed as compared with studies on probiotics. Several inconsistencies in safety reporting were identified between and within drug and probiotic studies, such as: didn’t report on safety; only reported adverse reactions (ARs) or adverse events (AEs) with a certain severity; didn’t report the total number of AEs; didn’t split in the control- or experimental arm; didn’t specify AEs; and used different thresholds for ‘common’ AEs. Hence, it is difficult to compare safety data from drug and probiotic RCTs across and between different studies. On the current approaches to safety reporting, we could not establish an unambiguous safety profile for neither probiotic and drug interventions in IBS. These shortcomings hamper a critical comparison of the burden to benefit ratio for IBS intervention.

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