Details of risk-benefit communication in informed consent documents for phase I/II trials.

BACKGROUND: Informed consent documents for clinical studies should disclose all reasonably foreseeable risks and benefits. Little guidance exists on how to navigate the complexities of risk-benefit communication, especially in early clinical research. Practice-oriented development of such guidance should be informed by evidence on what and how details of risks and benefits are currently communicated. METHOD: We surveyed the responsible parties of phase I/II trials registered in ClinicalTrials.gov that started 2007 or later and completed between 2012 and 2016 to sample informed consent documents from a broad spectrum of early phase clinical trials. Based on an assessment matrix, we qualitatively and quantitatively assessed the informed consent documents for details of risk-benefit communication. RESULTS: The risk-benefit communication in the 172 informed consent documents differed substantially in several regards. The outcome, extent, and likelihood of health risks, for example, were described in 83%, 32%, and 63% of the informed consent documents. Only 45% of informed consent documents specified the outcome of mentioned health benefits, and the extent and likelihood of health benefits were never specified. From those informed consent documents reporting risk likelihoods, only 57% added frequency numbers to words such as "common" or "rare," and even in these cases, we found strong variations for presented frequency ranges. Substantial heterogeneity also exists for how informed consent documents communicate other risk and benefit types and related safeguards. CONCLUSION: Our study points to several shortcomings and heterogeneities in how informed consent documents communicate risks and benefits to potential research participants. Health risks, for example, should be specified with frequency numbers, and health benefits should be specified at least by mentioning their outcomes. Further demand for research and policy development is needed to harmonize risk-benefit communication and to clarify ways to specify the likelihood of health benefits.

Result dissemination from clinical trials conducted at German university medical centers was delayed and incomplete.

OBJECTIVES: Timely and comprehensive reporting of clinical trial results builds the backbone of evidence-based medicine and responsible research. The proportion of timely disseminated trial results can inform alternative national and international benchmarking of university medical centers (UMCs). STUDY DESIGN AND SETTING: For all German UMCs, we tracked all registered trials completed between 2009 and 2013. The results and an interactive website benchmark German UMCs regarding their performance in result dissemination. RESULTS: We identified and tracked 2,132 clinical trials. For 1,509 trials, one of the German UMCs took the academic lead. Of these 1,509 "lead trials," 39% published their results (mostly via journal publications) in a timely manner (<24 months after completion). More than 6 years after study completion, 26% of all eligible lead trials still had not disseminated results. CONCLUSION: Despite substantial attention from many stakeholders to the topic, there is still a strong delay or even absence of result dissemination for many trials. German UMCs have several opportunities to improve this situation. Further research should evaluate whether and how a transparent benchmarking of UMC performance in result dissemination helps to increase value and reduce waste in medical research.