…However, informed consent is even less easily achieved in the modern arena of complex new molecular and cellular therapies. In this article, we argue that as science confronts new issues such as transplantation of stem cell products, which may live within the participant for the rest of their lives, researchers must carefully consider and constantly re-examine how they properly inform subjects considering participating in trials of these novel therapeutic strategies. (Journal of Law Med Ethics)
Physicians Often Ignore Phase III Findings in Managing Patients
Much has been discussed regarding the increasingly recognized limitations of phase III randomized trials in defining the future of cancer management and, indeed, there are many reasons to question whether there is genuine value in such efforts…More important, however, is another serious limitation of phase III randomized trial results in the oncology arena: how much do they actually influence clinical practice? (OncLive)
June 21 SDCRN program blog. “Implementing patient-centric strategies in a natural history trial: a case study”
Here is blog Report from SDCRN + San Diego ACRP Chapter joint program on June 21 IMPLEMENTING PATIENT-CENTRIC STRATEGIES IN A NATURAL HISTORY TRIAL: A CASE STUDY Blog by Roberta Alexander, Ph.D. The San Diego Clinical Research Network (SDCRN) (Clinical Research News, Developments, Resources & More) and the San Diego Read more
June 21 SDCRN program slides. “Implementing patient-centric strategies in a natural history trial: a case study”
Here are the presentation slides from the joint meeting of San Diego Clinical Research Network and Greater San Diego Area Chapter of ACRP on June 21. IMPLEMENTING PATIENT-CENTRIC STRATEGIES IN A NATURAL HISTORY TRIAL: A CASE STUDY Speaker: Jacqui Blem, Senior Director, Clinical Operations, Regulus Therapeutics Patient centricity is one of the Read more
May 9 SDCRN program slides. “How Mobile Tech is Transforming Clinical Research.”
Here are the slides for the San Diego Clinical Research Network + San Diego Regulatory Affairs Network program on May 9. Clinical Trials in the Future. How Mobile Technologies and Telemedicine are Transforming Clinical Research. UNLOCKING ACCESS: HOW MOBILE TECHNOLOGY ACCELERATES DISCOVERY Kevin Bruhn, Ph.D., VP, Strategic Development, Science 37 The Read more
Tips for optimizing sponsor/CRO relationships
Rho. Webinar. Optimizing Sponsor/CRO Relationships. May 10, 2016. Report by Roberta Alexander, Ph.D. On May 10, Rho offered a free online webinar on Optimizing Sponsor/CRO relationships, led by Jamie Arnott and Kristen Snipes from Rho. Here, Dr. Roberta Alexander of SDCRN summarizes the key points of this valuable webinar. You may Read more
May 9 SDCRN program blog. “How mobile tech is transforming clinical research”
May 9, 2016. SDCRN+SDRAN joint program The Future of Clinical Trials. How Mobile Technologies and Telemedicine are Transforming Clinical Research By Roberta Alexander, Ph.D. San Diego Clinical Research Network (SDCRN) and San Diego Regulatory Affairs Network (SDRAN) came together to discuss ways to utilize telemedicine and mobile technologies in clinical Read more
SDCRN June 21 mtg. Blog. “Implementing patient-centric strategies in clinical trials
Implementing Patient-Centric Strategies in a Natural History Trial: A Case Study Blog by Roberta Alexander, Ph.D. The San Diego Clinical Research Network (SDCRN) (Clinical Research News, Developments, Resources & More) and the San Diego Chapter of the Association of Clinical Research Professionals (ACRP) (http://www.acrpnet.org/) co-organized an event on June 21st, Read more
ClinOps has important role to play in improving the patient experience
Patient Centricity: ClinOps Taking the Lead
Patient centricity continues to gain steam as a critical component to any well-run clinical trial…As a result, Clinical Operations (ClinOps) has only been a small part of this discussion. As a 25-year veteran in the industry, my perspective is that ClinOps has a critical role to play in improving the way pharma is partnering with patients to execute better and more efficient clinical trials. (Drug Discovery and Development Magazine)
2015 a year in review: the year of clinical trial innovation
www.appliedclinicaltrialsonline.com
The clinical trials industry has undergone quite a bit of change in 2015, and may arguably be deemed the year of the ramping of clinical trial innovation.