ARTICLES BY ED MISETA
Dispelling The Misconceptions Of Conducting Clinical Trials In Russia10/8/2021
Russia is a growing area for clinical trials. In 2018, 654 new trials were approved in Russia. Approximately 50% of those trials were initiated by multinational companies led by Novartis, Roche, Pfizer, Janssen, Abbvie, AstraZeneca, and Merck. Oncology trials led the way with 114 trials, followed by rheumatology and neurology.
Decentralized Trials Can Overcome The Challenges Of Rare Disease Patients10/5/2021
There are 400 million people worldwide who are impacted by more than 7,000 identifiable rare diseases. While individual rare diseases are uncommon, approximately 5% of the world’s population suffers from one. A new report from technology provider THREAD details how many of the clinical challenges posed by rare disease trials can be alleviated by decentralized trials.
Seagen Leverages Partnerships to Understand Patient Perspectives9/30/2021
Patient recruitment, retention, and diversity in clinical trials has been an ongoing challenge. While there is an industry-wide effort underway to try and address these issues, they will not be truly impacted until researchers are able to create a better patient experience, do a better job of reaching patients from diverse communities, building true relationships, and working to co-create solutions as equal partners.
Janssen’s Personalized Approach To Depressive Disorder Patients9/28/2021
Janssen is currently developing new treatments for patients with depressive disorders. The company is focused on patients with treatment resistant depression (TRD), or patients who did not have success with existing drugs. To help those patients, the company opted to take a personalized approach to the treatments.
Five Issues That Must Be Addressed To Advance The Use Of RWE9/21/2021
Edith Perez, CMO for Bolt Biotherapeutics, believes the industry has historically struggled to deliver on the promise of RWE. She notes there are five issues that still exist around the gathering and use of real-world data (RWD) that the industry will need to overcome.
Can Smarter Study Design Relieve The Recruitment Challenge?9/18/2021
Recruitment has always been a challenge for companies conducting clinical trials. Sponsor companies seeking new ways to engage and recruit patients have seen varied success. But could that challenge be mitigated or eliminated with smarter study design?
An Oral Cancer Therapy Hopes To Treat Multiple Tumors And Lymphomas9/7/2021
Cyclacel Pharmaceuticals recently announced the first patient dosed in its Phase 1/2 study of oral fadraciclib in patients with advanced solid tumors and aggressive lymphomas. The trial used a streamlined study design and will determine the recommended Phase 2 dose.
Traditional Trials Are Dead – Virtual Trials Are The Future9/3/2021
It’s no secret that decentralized clinical trials, also known as virtual trials, are one of the hottest technology trends in the clinical space. Although this trial model has been touted by vendors for many years, it took the emergence of the COVID-19 pandemic in 2020 to get many companies scrambling to implement the new approach.
Liver Disease Requires A Patient-Centric Approach To Trials9/1/2021
89bio is focused on two large markets which CEO Rohan Palekar believes are underserved. The first is fatty liver disease, which in its late stages is called non-alcoholic steatohepatitis (NASH). The second is severe hypertriglyceridemia, or high levels of fat in the blood. Creating trials for these diseases required a patient-centric approach.
A Stem Cell Company Overcomes The Challenges Of International Trials8/26/2021
Performing global trials presents challenges that drug developers do not face in the U.S. Those challenges need to be considered and addressed in the planning process. Jim Joffrion, senior director of clinical development and operations for Athersys, discusses the challenges and the importance of the CRO selection process.