Drug Safety/Pharmacovigilance Featured Articles
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NEWS ROUNDUP: Precision Medicine And Patient Data, FDA Accuses CRO Of Data Fudging
4/22/2016
Clinical Leader news roundup for the week of April 18, 2016, with articles on precision medicine and whether it can compromise patient data, FTC help for mobile health app developers, retrospectively registered clinical trials, stem cell research and clinical trials, new patient engagement tools, and data fudging in India.
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New Coordination Hub And Distribution Center Serves Pharma’s Clinical Supply Needs
4/11/2016
In clinical trials, many functions have to operate smoothly and efficiently for an approval to be granted. With all of the attention being paid to patients, data, innovation, and new technologies, one aspect that can get overlooked is the packaging, labeling, and distribution of clinical supplies. No trial can take place unless sites – and ultimately patients – receive their required clinical supplies.
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NEWS ROUNDUP: Santa Claus, The Easter Bunny, And Patient Centricity?
4/11/2016
Clinical Leader news roundup for the week of April 4, 2016, with articles on Patient recruitment via Twitter, NIH sponsors trial of anti-HIV antibody, diversity in clinical trials, INC Research partners with CISCRP, the use of apps in clinical trials, and the myth of patient centricity.
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France Tragedy Reminds Us Phase 1 Researchers Must Live With Tragic Results
3/29/2016
The recent clinical research tragedy in France that resulted in the death of one patient and the hospitalization of four others shocked many who work in the clinical research space. The adverse effects experienced by the previously healthy patients, reportedly involving deep brain bleeds, were both rare and disturbing.
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FDA And NIH Release Draft Clinical Trial Protocol Template
3/24/2016
The FDA and NIH are requesting public comment on a draft clinical trial protocol template that has been released for Phase 2 and Phase 3 IND (investigational new drug)/ (investigational device exemption) studies. The template contains instructional and sample text for NIH funded investigators to use when writing protocols.
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France Tragedy: Molecule Likely Caused “Off Target” Effect
3/10/2016
While many questions still surround the clinical tragedy in France, which resulted in the death of one patient and the hospitalization of four others, it seems certain at this point that the molecule administered to the patients is to blame.
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New Biologics Create Need For Patient-Friendly Injectors
3/8/2016
Analysts forecast that by the end of 2016, 50 percent of the top 100 drugs on the market will be biologics. Currently more than 900 biologic drugs are in development to treat a broad range of conditions, including cancers, immunologic disorders, and rare and chronic diseases. That the majority of new injectable treatments are biologics will present a new challenge in delivery of the medicines.
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IN CASE YOU MISSED IT: Clinical Leader Top 3 Articles For February 2016
3/1/2016
Below are my top three articles downloaded on Clinical Leader for the month of February 2016. In case you missed them, please take this opportunity to see what everyone else was learning about protocol design and EMA recommendations surrounding the clinical tragedy in France, and biopharma trends that will impact clinical trials in 2016.
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ClinicalTrials.gov: Progress Made, But One-Third Of Results Still Missing
2/24/2016
<p>ClinicalTrials.gov was created to inform the public of the results of clinical trials. Since the database went live in 2008, it has accumulated data on 200,000 trials in more than 170 countries. Compliance with established requirements is improving, but according to NIH data recently shared by Sen. Charles Grassley of Iowa, more than a third of applicable study results are still missing.</p>
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Clinical Trial Complexity, Diversity, And Right To Try Continue To Impact Pharma
2/16/2016
If it’s the first quarter of a new year, chances are that Michael Martorelli and his research team at Fairmount Partners has been hard at work preparing their annual questions issue of the Pharmaceutical Outsourcing Monitor. With the latest issue addressing 16 questions addressing pharma and biopharma companies for 2016, he once again does not disappoint readers.