• DE&I Initiatives May Need An Accessibility Component

    Clinical Research News | Ensuring the Black voice in clinical research was the focus of a panel discussion on diversity, equity, and inclusion (DE&I) at last week’s Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida. The conversation was led by two-time cancer survivor Kimberly Richardson, president of the Black Cancer Collaborative, who vividly recalls being scolded and silenced when she questioned why her slow-growing granulosa cell tumor needed to be aggressively treated with three-drug medicinal cocktail.

    Feb 21, 2022

  • Engaging Local Communities To Support Patient-Centric Clinical Trials

    Clinical Research News | Ways to effectively engage local communities in clinical research—as trial participants, study sites, and referral partners—was a top topic of conversation at the recent Summit for Clinical Ops Executives (SCOPE) in Orlando, Fla. Karen Correa, head of global clinical operations at Takeda Pharmaceuticals, focused on tactics for educating and motivating healthcare professionals to be ongoing clinical trial referrers, while Kafayat Babajider, associate director of patient portals for Janssen Research and Development, provided a status report on its six-month-old, insights-driven My Trial Community platform.

    Feb 18, 2022

  • New Program Brings AI to Enrolling Cancer Patients in Trials

    Clinical Research News | A leader in precision medicine and AI-enabled clinical trial enrollment for oncology patients has launched a program designed to simplify the enrollment process and open clinical trial access to all cancer patients. The goal of Massive Bio’s new 100K Singularity Program, which uses artificial intelligence (AI) and real-time access, is to transform the current clinical trial enrollment process.

    Feb 16, 2022

  • Inclusive Research Is Good For Business As Well As Science

    Clinical Research News | Inclusive clinical research matters to patients, shapes good science, and is imperative to business success, according to Meghan McKenzie, principal inclusion, internal partnering, in Genetech’s Chief Diversity Office. How to go about increasing diversity in clinical trials was the focus of her keynote presentation at last week’s Summit for Clinical Op Executives (SCOPE) in Orlando, Florida.

    Feb 15, 2022

  • Novartis Has An Evidence-Based Connected Health Vision

    Clinical Research News | Novartis has plans to develop one or more “connected health” solutions—a universe that includes connected devices, wearables, and software as medical devices (SaMD)—to be part of its drug program over the next five years. Its fledging digital health platform will be putting those tools in the hands of clinicians, patients, and researchers to improve the overall healthcare experience and access to trials, according to the keynote last week at the Summit for Clinical Ops Executives (SCOPE).

    Feb 14, 2022

  • PharmaLedger Project To Create Blockchain-Based Clinical Trial Solution

    Clinical Research News | A 36-month PharmaLedger project sponsored by the Innovative Medicines Initiative and the European Federation of Pharmaceutical Industries and Associations is attempting to create a scalable blockchain platform with use cases for clinical trials as well as supply chain and health data. In the trials arena, the focus initially was on eConsent, but the public-private initiative is now intent on creating an end-to-end solution for clinical trial conduct, according to a report given yesterday at the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida.

    Feb 10, 2022

  • Pandemic Pivots That Need To Persevere

    Clinical Research News | A fireside chat on what “fit-for-future” data operations might look like in a post-pandemic world was the topic of a keynote presentation on day two of the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida yesterday. The risk-benefit ratio on many innovative methodologies and technologies has flipped over the past two years, elevating their value in the “new normal” moving forward, as shared by executives from a trio of leading biopharmaceutical companies.

    Feb 9, 2022

  • Merck Using Virtual Reality To Make Pediatric Study Visits More Pleasant

    Clinical Research News | Merck took first place honors at Participant Engagement Award ceremonies on the opening day of the Summit for Clinical Ops Executives (SCOPE) in Orlando, Florida yesterday. Other honorees included Guardant Health and Tryl.

    Feb 8, 2022

  • Follow the Money: New Clinical Trials Platform, AI For Clinical Prediction, Cancer Risk Stratification

    Clinical Research News | Autoimmune disorder treatments, AI-Based clinical prediction, cancer risk stratification, available funding for clinical efficacy research, and more.

    Feb 8, 2022

  • Innovative Study Site Partnerships Help Sponsors Address The Challenges of Patient Centric Trials

    Clinical Research News | It is no surprise that the global pandemic has created challenges in allowing trial sites to conduct research focusing on efficiency and quality care. However, it has also brought to the forefront the long-established systemic issues that site teams face in trial operations and related patient care and staff burdens. Ongoing issues such as increasing administrative responsibilities and timely patient onboarding make it difficult for site teams to focus more of their time on the bigger picture of high-quality patient care.

    Feb 4, 2022

  • Trials for Mild Cognitive Impairment, Inflammatory Bowel Disease, MS; New ePRO Offering; THREAD Acquires InVibe

    Clinical Research News | Trials are in line for treating mild cognitive impairment, inflammatory bowel disease, and MS; ObvioHealth announces a new ePRO offering; positive results for Renalytix risk monitoring tool in diabetic kidney disease study; acquisitions, mergers, and more.

    Feb 2, 2022

  • Overcoming The Challenges of Outsourcing Rare Disease Trials

    Clinical Research News | Anyone who has ever played the game of telephone as a child knows only too well how a message can become completely scrambled by the time it passes through a succession of people. A similar type of communication breakdown can happen when a protocol gets communicated by a study sponsor to a contract research organization (CRO), and then handed off to study managers or monitors and ultimately clinical trial sites, especially for rare disease trials.

    Jan 31, 2022

  • The Emerging Role Of Pharmacists In Clinical Research

    Clinical Research News | The role pharmacists play in the community is the same one they should be playing in clinical research, according to Gerald Finken, founder and CEO of RxE2 whose mission it is to help make that happen. His belief is that “community-based clinical trials” in general can be better for patient care, the pharmacy as a profession, and study sponsors who have long had trouble recruiting enough patients into their studies.

    Jan 27, 2022

  • Looking Forward to EU Regulation (EU) No 536/2014

    Clinical Research News | The EU Clinical Trials Register will be implemented on 31 January 2022, with the launch of the harmonized Clinical Trials Information System (CTIS) in all EU and EEA Member States. It is one of the most fundamental changes in the regulatory landscape for clinical trials in Europe. It is both historic and exciting.

    Jan 26, 2022

  • Canadian Brain Institute Opens Data Sharing on Alzheimer’s, Parkinson’s, More

    Clinical Research News | After a decade of methodical preparation, Canada’s Ontario Brain Institute's (OBI) neuroinformatics platform, Brain-CODE, launched its open data sharing feature for global brain disorder research.

    Jan 25, 2022

  • Logistical Challenges Of The ‘Reverse Supply Chain’ For Biospecimens

    Clinical Research News | The pandemic has served to highlight shortcomings of traditional practices around the cold-chain transport of biospecimens for clinical trials—including no backup plans when airports, borders, and study sites unexpectedly close. Even in normal times, default choices such as contracting mostly if not exclusively with premium couriers, can “artificially increase the cost of clinical trial conduct,” in the view of Thomas McDonald, associate director of biospecimen logistics for Bristol Myers Squibb Co. (BMS).

    Jan 24, 2022

  • Where AI Can Add Efficiencies To Clinical Trials

    Clinical Research News | Acceptance of artificial intelligence (AI) in clinical research is on the rise thanks, in part, to its pairing with human expert oversight. The result is faster, more efficient clinical trials with less of the bias associated with purely manual evaluations while sidestepping the potential risks of AI.

    Jan 20, 2022

  • Trials@Home Exploring European Experience With Decentralized Model

    Clinical Research News | Next year, a pan-European pilot study gets underway comparing the performance of hybrid and fully decentralized clinical trial models with conventional brick-and-mortar settings where the endpoints are operational metrics such as recruitment speed and diversity of enrolled populations. The focus of the study—the cornerstone of the broader Trials@Home project—is to see what decentralized approaches are possible across a continent with a mix of different languages, regulatory authorities, and privacy laws.

    Jan 18, 2022

  • Parallelization Now Proven Approach in Clinical Trials

    Clinical Research News | Technology will continue to play a large role in how we conduct trials, but new ways of working will have to be implemented to truly drive change. During the COVID-19 vaccine trials, several new approaches emerged that helped speed the trials and bring the vaccines to market in record time. One such approach is fast-tracking, or parallelization.

    Jan 14, 2022

  • 2022 Participant Engagement Award Finalists Announced

    Clinical Research News | Finalists have been named for the sixth annual Participant Engagement Award. Their work will be highlighted, and a winner will be named at the upcoming 2022 Summit for Clinical Ops Executives (SCOPE), February 7-10 in Orlando, Fla.

    Jan 13, 2022