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Walgreens Boots Alliance has announced the launch of its new clinical trials business that aims to use patient data from its pharmacies to help drive up recruitment in studies conducted by drugmakers. With patient recruitment and enrollment remain key challenges in clinical trials, further exacerbated by the COVID-19 pandemic, the company said it can proactively match diverse patient populations to trials across a range of disease areas based on race, gender, socioeconomic status and location with its patient reach and access to an extensive foundation of pharmacy and patient-authorised clinical data. The Boots owner also believes that by leveraging a tech-enabled approach to patient identification and creating a large registry of clinical trial participants, the company will be able to reduce the time it takes to match eligible patients to clinical trials. "Walgreens trusted community presence across the nation, combined with our enterprise-wide data and health capabilities, enables us to pioneer a comprehensive solution that makes health options, including clinical trials, more accessible, convenient and equitable," said Ramita Tandon, chief clinical trials officer, Walgreens.

Researchers from the University of Oxford today (December 8) started recruiting for a clinical trial to test novel antiviral Covid-19 treatments for early use in the illness by people in the community and those who are at higher risk of complications. Partnering with the National Institute for Health Research (NIHR), colleagues in several UK universities, and the NHS UK-wide, the Platform Adaptive trial of NOvel antiviRals for eArly treatMent of Covid-19 In the Community (PANORAMIC), is a national priority trial, and will be open to participants from across the UK. The first treatment to be tested by the UK Antiviral Taskforce will be molnupiravir, a Covid antiviral pill already licensed by the MHRA. Britain became the first country in the world to approve molnupiravir, which was jointly developed by U.S.-based Merck & Co Inc and Ridgeback Biotherapeutics, in November.

GlaxoSmithKline and Sanofi said on Wednesday (December 15) they expect data from late-stage clinical trials of its booster dose of their Covid-19 vaccine candidate in the first quarter, instead of this year, another delay for the potential shot. The news came as two companies said preliminary data from trials showed the single-dose booster provided strong immune responses. They added that they need more time to test the booster on more people who have not been infected by the virus before they can submit data to regulators. The Phase III trial for the recombinant adjuvanted Covid-19 vaccine recruited most participants in the third quarter, coinciding with a significant increase in the number of people infected globally due to the Delta variant, it said. "To provide the necessary data to regulatory authorities for the booster vaccine submission, the trial will continue to accrue the number of events needed for analysis, with results expected in Q1, 2022." No safety concerns were identified. This is the latest delay for the vaccine's development, putting the companies further behind rivals in the race for Covid-19 shots.

Randomization and stratification are necessary components for recruitment patient for most multi-armed clinical trials. The purpose of randomization methods is to eliminate selection bias and to insure a balance of measured and unobserved covariates between the treatment groups. Block and permuted block randomization with stratification are typically used to avoid selection bias and insure balance between observed and unobserved confounding variables.