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Mailed outreach promoting colorectal cancer (CRC) screening with a stool blood test kit may increase participation, but magnitude and consistency of benefit of this intervention strategy is uncertain. Our aim was to conduct a systematic review and meta-analysis of randomized controlled trials (RCTs) comparing mailed outreach offering stool tests to usual care, clinic-based screening offers on CRC screening uptake in the USA. We performed a systematic literature search of five databases for RCTs of mailed outreach from January 1980 through June 2017. Primary outcome was screening completion, summarized using random-effects meta-analysis as pooled differences in proportion completing the screening and relative risk of achieving screening compared to control. Subgroup analyses by test type offered-fecal immunochemical test (FIT) or guaiac fecal occult blood test (gFOBT), the presence of telephone reminders, and the presence of predominant underserved/minority population within study were performed. Quality of evidence was evaluated using the GRADE framework. Seven RCTs which enrolled 12,501 subjects were included (n = 5703 assigned mailed outreach and n = 6798 usual care). Mailed outreach resulted in a 28% absolute (95% CI 25-30%; I2 = 47%) and a 2.8-fold relative (RR 2.65, 95% CI 2.03-3.45; I2 = 92%) increase in screening completion compared to usual care, with a number needed to invite estimated to be 3.6. Similar outcomes were observed across subgroups. Overall body of evidence was at moderate quality. Mailed outreach offering a gFOBT or FIT is associated with a large and consistent increase in CRC screening completion and should be considered for more widespread implementation for improving screening rates nationwide. [ABSTRACT FROM AUTHOR]

An IQ consortium working group (WG) conducted a survey across multiple biopharmaceutical companies to gain information about the level of blinding commonly utilized for early clinical development trials. The main objectives were: (1) to understand blinding practices between healthy volunteer (HV) and early explorative patient trials in all therapeutic areas except oncology where early clinical trials are commonly open-label; (2) to understand the rationale for blinding/unblinding practices; (3) to understand the groups and personnel involved in unblinding; and (4) strategic considerations around blinding/unblinding options in early clinical development trials-risk of bias vs. potential for acceleration. A survey containing 31 main questions with additional sub-clarifying questions was conducted. Sixteen large and mid-size pharmaceutical companies responded. Responses were aligned across functions within each participating company. Additional information was gathered at an American Association of Pharmaceutical Scientists (AAPS) webinar with polling options to roughly 550 registered attendees to evaluate the reason for the unblinding decisions. The results revealed divergence across companies in the blinding approaches most commonly applied but with some study types, there were clearly favored options. Based on these results, the WG developed strategic considerations for first-in-human HV trials and nonpivotal explorative trials in patients. This paper should facilitate discussions among various clinical development functions, such as Clinical Pharmacology, Statistics, Clinical, Bioanalytics, and Regulatory Functions. Such discussions on study design and operations are warranted to allow implementation of more flexible blinding approaches to accelerate data driven decisions in drug development and allow earlier access of patients to needful medicines., (© 2021 The Authors. Clinical and Translational Science published by Wiley Periodicals LLC on behalf of American Society for Clinical Pharmacology and Therapeutics.)