Upcoming Webinars Archived Webinars Training Vitals Host A Webinar About Get Updates Contact

FDA Commissioner Wants To Build Preclinical Database

XTALKS VITALS NEWS

Robert Califf

"It would really be good to have something like a ClinicalTrials.gov for preclinical work," said FDA commissioner, Robert Califf.

Share this!

June 13, 2016 | by Sarah Massey, M.Sc.

Robert Califf, the commissioner of the US Food and Drug Administration (FDA) thinks an official database for preclinical studies should be established in order to help improve transparency in basic research. The database would be modeled after ClinicalTrials.gov, an online clinical trials registry in which sponsors are required to register their studies.

According to Califf, the goal of the preclinical database would be to gather data from studies conducted in cell culture or on animal models. Califf hopes that providing preclinical data in a public-accessible database could help improve future researchers’ attempts to reproduce study results.

“One of the problems that we have at the FDA in this regard is that trade secrets at the FDA are protected by the law,” said Califf. “And I’ve always felt that one of the most important things that could be done, if it could be, would be free up all the data from the drug development process that is never seen by anyone.”

Tweet: #FDA's Robert Califf wants to register #preclinical studies http://ctt.ec/dcIN3+

“Because there is no compelling reason to publish them, if they’re successful, they become trade secrets,” Califf continued. “And if they’re unsuccessful, they get dropped and no one cares if they’re published. If you think reproducibility and the fabric of science, in some ways, if it were possible, it would really be good to have something like a ClinicalTrials.gov for preclinical work.”

ClinicalTrial.gov collects clinical trials data from hospitals, research universities and pharmaceutical companies conducting treatment studies on humans. Though these study sponsors are required to report this data by law, up to 70 percent of trials go unreported on the government website.

Currently, no preclinical database exists to aggregate study results from in vitro trials. As a result of this lack of data sharing, preclinical research used to advance a drug into human clinical trials, often cannot be replicated later on. Publication basis towards studies with negative or inconclusive results serves to further complicate the issue.



“Knowing what the dead ends are would make things more efficient for the system as a whole,” said Stuart Buck, leader of the Research Integrity initiative at the Laura and John Arnold Foundation. By registering preclinical data, prospective researchers would know what studies have already been performed and what the results of that work were. This would eliminate some redundancy among researchers, allowing them to make better study decisions from the onset.

Not everyone agrees that a preclinical database would solve these difficult issues. According to Elizabeth Iorns, founder and CEO of the Science Exchange – a company that fosters collaboration in the research community – says that funding for replicative research is simply not available.

“There’s no funding for it. Nobody wants to do it. No one publishes it,” Iorns told STAT. “Exploratory research is exploratory. You shouldn’t preregister it. You shouldn’t have a statistical analysis planned. That would be crazy. It would stifle so much innovation and serendipity that just happens.”


Keywords: FDA, Preclinical, Clinical Trials Data


| NEXT ARTICLE | MORE NEWS | BLOGS | VIDEOS | POLLS & QUIZZES | WEBINARS |

Share this with your colleagues!

MORE NEWS
New Self-Injectable Form of Lupus Drug Approved by the FDA

July 25, 2017 - Patients with systemic lupus erythematosus (SLE) will now have the option to self-inject their medication thanks to the FDA approval of GSK’s reformulated lupus drug, Benlysta (belimumab).

Featured In: Biotech News


Canadian Chicken Farmers to Further Reduce Use of Antibiotics

July 24, 2017 - The Chicken Farmers of Canada, a national group dedicated to supporting poultry farmers and helping them meet consumer demand for chicken, has announced their strategy for eliminating the use of certain antimicrobials in meat production.

Featured In: Food News


Neonatal MRI Medical Device Approved by the FDA

July 24, 2017 - Medical device maker Aspect Imaging has received US Food and Drug Administration (FDA) approval for its Embrace Neonatal MRI System.

Featured In: Medical Device News


LEAVE A COMMENT
 
  
THE XTALKS VITALS INDUSTRY BLOG

Manufacturing Control Strategies: What Pharmaceutical and Biotech Companies Need to Know

REGISTER FOR THESE WEBINARS

Outsourcing Pharmacovigilance: Pros and Cons and Lessons Learned


EDC and eSource: Combined for Better Data and Faster Insights


Using Model Reduction to Bridge the Quality Systems Pharmacology-Pharmacometrics Divide


How to Maximize Your Non-GLP Toxicology Studies: A Guide for Optimal Design and Methodology


Copyright © 2016-2017 Honeycomb Worldwide Inc.