Digital Health/Clinical Trials Newsletter

HITLAB Invites Clinical Trial Enthusiasts To Participate in a Survey on use of Digital Technologies in Clinical Trials

?HITLAB?is conducting research on the use of digital technologies, including remote monitoring, for decentralized clinical trial (DCT) designs and is asking for trial specialists to complete a brief survey:?Clinical Trial Enthusiast Survey.?After?receiving a representative set of responses, our Chair, Dr. Stan Kachnowski, will publish a paper on our findings. The survey is confidential and used for research.

Evidence from ClinicalTrials.gov on the growth of Digital Health Technologies in neurology trials

Digital Health Technologies (DHTs) such as connected sensors offer particular promise for improving data collection and patient empowerment in neurology research and care. This study analyzed the recent evolution of the use of DHTs in trials registered on?ClinicalTrials.gov?for four chronic neurological disorders: epilepsy, multiple sclerosis, Alzheimer’s, and Parkinson’s disease. We document growth in the collection of both more established digital measures (e.g., motor function) and more novel digital measures (e.g., speech) over recent years, highlighting contexts of use and key trends.

Clinical Trials And Prior Disclosure – A Difficult Balancing Act For Patentees

The European Patent Office (EPO) has recently ruled that patients in a clinical trial?were not?members of the public such that the trial?did not?constitute prior public use of a pharmaceutical formulation (Board of Appeal decision T 0670/20). This decision adds to the growing body of EPO case law surrounding the topic of disclosures relating to clinical trials and provides more legal certainty for patentees with drug formulation patents.

DiMe releases resources aimed at diversity in digital clinical trialsThe?resources?include a guide to each step of a digital clinical trial, shared definitions of terms like "diversity" and "equity," a list of different digital tools that could be used and the potential benefits and risks, and recommendations on how to effectively use those tools to enroll and retain more trial participants.?

USING AI TO MATCH THE RIGHT PATIENTS TO THE RIGHT CLINICAL TRIALS

?For busy clinicians, determining whether a patient makes a good candidate for a clinical trial is often low on the list of things to do during a healthcare visit. But AI technology is making that process much easier, and opening the door to potential life-changing health outcomes.

Growing Need for Streamlined Clinical Trials Drives Growth of E-Clinical Solution Software Market

The?E-Clinical Solution Software market?is a rapidly growing market due to the increasing adoption of e-clinical solutions by pharmaceutical companies and contract research organizations to improve efficiency and reduce costs in the clinical trial process. The growing trend of outsourcing clinical trials to emerging countries also presents a significant opportunity for the e-clinical solution software market.