Editorial Perspectives On Decentralized Trials

41. #NoGoingBack Supports Keeping Patients First 1/5/2021

    #NoGoingBack has been gaining a lot of attention of late. Founded by Signant Health and supported (and chaired) by industry leaders like Craig Lipset of Clinical Innovation Partners and Allyson Small of SCRS, the group has been pushing for permanent adoption of the trial changes implemented in 2020 to keep patients safe from COVID-19 and drive often-discussed innovation into standard trial practice.

42. Tread Carefully Into Virtual Clinical Trials 12/21/2020

    With the COVID-19 pandemic’s impact on clinical trials in the U.S. and around the world, everyone is suddenly focused on virtual (decentralized) clinical trials. But if you plan to move your trials to a virtual model, at least one industry executive is recommending that you use caution when doing so. 

43. X4 Pharma Adjusts Clinical Trials For A COVID World 12/17/2020

    With the COVID pandemic afflicting patients around the world, those with a compromised immune system are at even greater risk. X4 Pharma is currently conducting a global Phase 3 trial that was underway when the pandemic hit, and is for patients who are immunocompromised.

44. Lilly, Care Access Take COVID Trial Directly To Patients 12/10/2020

    Eli Lilly and Company and Care Access Research have forged a unique partnership to develop and manage a first-of-its kind decentralized, mobile trial to safeguard the health of patients in nursing homes. Lilly and Care Access will take the trial directly to patients. 

45. Four Steps Sponsors Can Take To Increase Patient Recruitment 12/2/2020

    There are many reasons for the low percentage of patients who opt to participate in clinical trials. Many do not know trials exist, most physicians do not refer their patients to trials, and even when a patient becomes aware of these studies, misconceptions and the burden of trials can be enough to steer them away.

46. FDA: We Can Speed Drug Development With Tech Innovation 11/24/2020

    In March 2020, the COVID-19 pandemic began to shut down normal day-to-day activities in the U.S. No industry was spared, including drug discovery. During her keynote address at the 2020 Veeva R&D Summit, Amy Abernethy, principal deputy commissioner & acting CIO for the FDA, discussed how the agency responded.

47. How Has COVID Impacted The Clinical Trial Pipeline? 11/12/2020

    As we come to the end of 2020, the world remains focused on finding a vaccine that is effective at halting the spread of COVID-19. The pandemic is already responsible for the deaths of over 1 million people worldwide. In 2020 it also resulted in the cancelling or delay of numerous non-COVID trials for other important medications. 

48. A New Patient-Centric Virtual Trial Targets Rare Cancers 10/20/2020

    The TargetCancer Foundation, with support from Bayer, has launched a study to research genomic testing in people with rare cancers. The study, called TRACK (Target Rare Cancer Knowledge), has already enrolled the first patients in the U.S. Those patients have been diagnosed with rare cancers, including those with cancers of unknown primary (CUP). 

49. New Playbook Helps Sponsors Implement Digital Technologies In Trials 10/13/2020

    Companies interested in implementing digital devices into trials now have a reference source for information. The Playbook is a new tool developed by DiMe (Digital Medicine Society), Elektra Labs, Koneksa Health, Genentech, MyoKardia, Sage Bionetworks and Scripps Research. It is being billed as the essential industry guide for successfully developing and deploying digital clinical measures across clinical research, clinical care, and public health. 

50. Rare Disease Trials Require Interactions With KOLs, Patients, & Regulators 9/9/2020

    Anyone working in the orphan or rare disease space knows the lack of a natural history for a disease is one of the greatest challenges a company might face. The same is true for Minoryx Therapeutics. According to CEO Marc Martinell, the lack of a natural history means companies do not have the information necessary to determine how clinical trials should be designed.