December 27, 2021 | At Clinical Research News, 2021 saw another heavy dose of COVID-19-related coverage, but it took a turn away from the unknown toward review of the success stories that allowed vaccines to be produced and distributed so rapidly. Businesses everywhere also looked to leverage the COVID-associated disruptions to the benefit of themselves and society—with new technology to enable and facilitate decentralized clinical trials, arguments for the increased acceptance of external control arms, and the place of AI in clinical data. We also explored practical ideas for increasing clinical trial diversity and reported on a new initiative for better data sharing and standardization in the realm of rare diseases.

It took a Village to Speed COVID-19 Vaccines into Arms: Deb Borfitz tells the story of the massive parallel effort that Pfizer used to set their record-breaking pace for vaccine development and approval, including some lessons learned.

How Pfizer’s ‘Science Will Win’ Mantra Played Out Behind the Scenes: Several Pfizer executives spoke at the Summit for Clinical Ops Executives (SCOPE), continuing the discussion of Pfizer’s rapid vaccine development effort. Greater detail is provided into the accelerated efforts around team shuffling, investigator recruitment, frequent meetings, and data analysis.

MedVector to Connect Patients of Local Physicians to Study Investigators: We covered the startup MedVector and their technology that facilitates decentralized clinical trials by giving study principal investigators a “window” to interact with patients and oversee their visits with regular primary care physicians. Plans for the company to align patient, doctor, and PI incentives as well as the step-wise launch of their products are discussed.

Studies Using External Control Arms Gaining Ground: Experts from Merck, Bristol-Myers Squibb, and Ikaika Health presented at the DIA 2021 Global Annual Meeting, and we learned more about how external control arms can be used in certain studies, clarifying both drawbacks and advantages.

Practical Ideas for Improving Clinical Trial Diversity: The DIA 2021 Global Annual Meeting also featured an expert panel formed to discuss ideas for improving diversity in clinical trials—such as increased family inclusion, the launch of a TV show in Spanish to educate the Hispanic community about participation in trials, and the perspectives of minority patients.

How Pfizer Used Intelligent Machines to Take on Clinical Data: At the Bio-IT World Conference & Expo, Prasanna Rao, Head of AI and Data Science at Pfizer, talked about the place for AI in the drug development process with an emphasis on several use cases in clinical trials.

Bringing the Fight to Antimicrobial Resistance: What COVID-19 Has Taught Us About How to Face a Growing Emergency: The case is presented for using lessons learned from rapid vaccine development and clinical trial operation in the face of the COVID-19 emergency to address the ongoing problem of antimicrobial resistance.

Data-Sharing Platform Aims to Speed Drug Development for Rare Diseases: A new platform was established by the Critical Path Institute to accelerate treatment for rare diseases by standardizing and integrating data across associated datasets. Example use cases are given with Duchenne muscular dystrophy and Friedreich’s ataxia.