Clinical Research Units Featured Articles

1. Proposed Tax Change Would Impact Clinical Research 4/11/2017

   Pharma companies that conduct clinical research inhouse essentially get a 100 percent tax break on the expenses incurred from that research (about 70 percent of which are normally wages). If they instead outsource that research to a CRO, they may claim only 65 percent of eligible expenses. The CRO gets no tax break, so that 35 percent difference simply disappears. If a group of congressmen get their way, that situation might soon change.

2. Genelux Trials Use Vaccine Virus To Attack Tumors 11/22/2016

   Genelux is an oncolytic virus company that was formed in 2001 and has been conducting clinical trials since 2009. The company completed four Phase 1 studies which have enabled it to design what CEO Thomas Zindrick describes as an advanced clinical program.

3. France Tragedy Update: Bial & Biotrial At Fault; EMA Reviews Guidelines 6/1/2016

   After the clinical tragedy in France in January, the French Health Ministry has found blame with the two companies involved in the trial, noting Bial and Biotrial were at fault on several counts. The EU has guidelines in place to ensure that does not happen again.

4. Can Exco InTouch Bring Added Value To Oracle’s InForm? 5/12/2016

   Oracle and Exco InTouch announced a partnering agreement that will integrate Exco InTouch’s ePRO patient engagement platform with Oracle Health Sciences’ InForm electronic data capture (EDC) system. The combination of the two platforms is expected to deliver enhanced workflow efficiency in clinical trials. But is the partnership truly a win for both companies?

5. After Government Debacle, Is It Any Easier To Perform Clinical Trials In India? 4/14/2016

   In May 2014, I interviewed Mithra Bindhu of India-based Asiatic Clinical Research to get an update on performing clinical trials in that country. The DCGI (Drug Controller General of India) had recently attempted to overhaul the entire system, which took a long time, complicated the process of conducting trials in India, and caused some sponsors to question the value of doing business there. Has the situation changed?

6. 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.   

7. Report: EMA Recommendations Were Not Followed In France 2/1/2016

   ANSM, the national drug safety agency in France, has issued a timeline of the events that culminated in the death of one trial participant and the hospitalization of five others at a clinical trial performed at clinical research firm BIOTRIAL. As was speculated by researchers at the UK’s Royal Statistical Society (RSS) last week, the timeline confirms that all six of the volunteers who were hospitalized after the study received an escalation of the dose at the same time.

8. Did Poor Protocol Design Lead To The Clinical Accident In France? 1/25/2016

   Did the clinical trial in France that has left one person dead and several others hospitalized have flaws in the protocol design? While we continue to await new information on what may have caused the tragedy, some researchers are already speculating on whether or not the design of the trial may have been a factor, and are demanding more information be released.

9. Is There A Link Between The France Tragedy And Legal Highs? 1/20/2016

   By now you have heard about the tragic clinical trial in France that has resulted in the death of one person and the hospitalization of four others. While full details of what caused the fatal death of a healthy man are still not available, we do know the trial was likely testing an FAAH-inhibitor. Maia Szalavitz, writing on the website Vice.com, says this should be a wakeup call to some legal substance users in the U.S.

10. Quantitative Systems Pharmacology Brings Value To Drug Development 1/12/2016

    Quantitative systems pharmacology (QSP) sits at the interface between pharmacometric modeling and simulation, and systems biology. It uses mathematics to describe biological processes. While pharmacokinetics describes what the body does to the drug, pharmacodynamics quantifies what the drug does to the body; the pharmacological response. QSP is a mechanistic modeling approach and an emerging technology, which mathematically integrates pharmacokinetics, pharmacological response and disease progress/modulation.