A recent study of clinical drug development success rates found that biomarker-enabled drug programs are three times more likely to reach approval. (Outsourcing-Pharma.com)
Top scientists hold closed meeting to discuss building a human genome from scratch
Over 130 scientists, lawyers, entrepreneurs, and government officials from five continents gathered at Harvard this week for an “exploratory” meeting to discuss the topic of creating genomes from scratch — including, but not limited to, those of humans, said George Church, Harvard geneticist and co-organizer of the meeting. (STAT)
EHR Data in Clinical Trials: New FDA Draft Guidance
The US Food and Drug Administration (FDA) on Monday released draft guidance to assist clinical trial sponsors, investigators, contract research organizations (CROs), institutional review boards (IRBs) and other using electronic health record (EHR) data in FDA-regulated clinical investigations. The 12-page guidance is meant to facilitate the use of EHR data in clinical trials and “promote the interoperability of EHRs and electronic systems supporting such trials.” (raps.org)
Many Americans Have Reservations About Clinical Trials
Just four in 10 Americans have a positive impression of clinical trials, and only about one-third of Americans would be likely to enroll in one, according to a study commissioned by the Memorial Sloan Kettering Cancer Center in New York City…
More than half (55 percent) of those surveyed were worried about side effects and safety. Half were concerned about insurance coverage and out-of-pocket costs. Nearly half (48 percent) were concerned about the inconvenience of trial locations, or receiving a placebo instead of an active treatment drug (46 percent). Additionally, 35 percent of those surveyed expressed skepticism about unproven treatments, while 34 percent said a clinical trial would make them feel like a guinea pig. (doctorslounge.com)
Coursera class. Understanding Clinical Research: Behind the Statistics
Genomic and Precision Medicine on Coursera
This free online 7-week course aims to educate the health care workforce in the field of genomic and precision medicine. Materials also available through the UCSF website.
BIO study concludes the success rate of a Phase 1 drug is 10% (Bio.org)
BIO, a lobbying group for the biotechnology industry, said the success rate of a drug in Phase-I development was 10% for all indications outside of oncology, according to its new report. Cancer drugs have only a 5% success rate.
Silicon Valley technology can enable faster and better preclinical research
Bridging the ‘cultural gap in drug development’ with Silicon-Valley technology
Sensors, computer vision, machine learning, and cloud computing are enabling preclinical researchers to conduct higher quality studies in a shorter period of time. (Outsourcing-Pharma.com)
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)
SDCRN program on May 9 will feature Noah Craft, CEO and Co-Founder of Science 37
Noah Craft, M.D., Ph.D., CEO and Co-Founder of Science 37, will be speaking in San Diego on May 9 at a program jointly organized by San Diego Clinical Research Network and San Diego Regulatory Affairs Network, Accelerating Clinical Trials Using Mobile Technologies: Current Trends and Regulatory Update. The program will be Monday May 9, 5:15-8:00 Read more
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