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Today the eClinical Forum submitted comments on 2 different EMA draft reflection papers: Interactive Response Technologies, and Risk Based Quality Management. Thanks to everyone who worked on these -- it is a true testimony to the collaboration that is the basis for all the eClinical Forum work, that these comments can be jointly worked on and agreed by members from bio-pharma, CROs, and software and service vendors. Copies of the comments are availalbe for download in the "Knowledge" tab on this website.
The eClinical Forum Spring 2012 Meetings:
* May 7-9 at Novartis Campus in East Hannover, NJ
* May 21-23 at Oracle Campus in Paris, France
Meeting topics will be chosen by the Steering Committee in 1Q 2012. Anyone interested in presenting or suggesting a topic, please send a note to Richard or Suzanne at info@eclinicalforum.com.
We concluded 2 very successful Autumn Workshops (in Newport Beach California -- hosted by Allergan, and in Strasbourg, FR -- hosted by eCF). Both meetings were rated very positively by participants on the post-meeting evaluation forms, with comments especially noting the highly participative nature of the group, the open sharing, and the value of the out-of-session interactions. Many of the eCF subgroups hosted workshops to gather member feedback to their out-of-meeting discussions. Meeting outcomes and presentation materials are available to members in the Members Only section of this website.
The EHRCR Project (sponsored by the eClinical Forum) announces the document release:
Practical Considerations for Clinical Trial Sites using
Electronic Health Records (EHRs)
Certified for Clinical Research
Addressing Regulatory Considerations
Release 1.0 June, 2011
This is the first paper of its kind, speaking directly to clinical research investigative sites regarding the use of electronic health record systems. It is based on clinical research regulations and guidances and includes a checklist for sites to assess how their systems (whether certified or not), and their processes comply.
The EHRCR Project is comprised of members from pharmaceutical sponsors, CROs, software vendors (both CR and EHR), and has included regulatory review. They have produced an EHRCR Functional Profile which is now an ANSI/HL7 standard, approved by EuroRec, and is currently under consideration to become a CEN/ISO standard. The profile (a) is founded on current clinical research regulations / guidances, (b) translates requirements into measurable criteria to assess suitability of a system for clinical research, and (c) was used as a input for the recently released CCHIT Certified® 2011 Clinical Research certification option for Ambulatory EHRs. (For more information on the EHRCR Project: www.ehrcr.org ) The document can be downloaded from the KNOWLEDGE section of this website.
The eClinical Forum sponsors a members-only Linkedin Group (called "eClinical Forum") in which members pose questions to each other, exchange ideas, and keep informed on eClinical Forum activities. Anyone from an eClinical Forum member company is welcome to join. The same "rules" as for the eClinical Forum apply --- the Linkedin discussion group is non-commercial and non-competitive, allowing for free-flowing of ideas in a "think tank" type environment.
April 5, 2011: The eClinical Forum members met several times to discuss the FDA draft document. As the eCF is a group comprised of bio-pharam companies, CROs, clinical research software vendors and electronic healthcare system vendors from both the US and Europe, these discussions were very balanced and all angles of the document were discussed. Results of these discussions were formulated into comments, agreed by all participants, and submitted to the FDA. If you are interested in reviewing the comments, please go to the Knowledge tab.
Early Cancer Detection Via New Blood Test: Research In The Early Stages Of Clinical Trials
Wed, 22 Feb 2012 08:00:00 +0000
A simple blood test is being developed by researchers at Ben-Gurion University of the Negev (BGU) and Soroka University Medical Center in Beer-Sheva, Israel that may provide early detection of many types of cancer. Prof. Kapelushnik of BGU's Faculty of Health Sciences and his team developed a device that illuminates cancer cells with less than a teaspoon of blood...
Drug Combo Kills Pancreatic Cancer Cells
Tue, 21 Feb 2012 17:00:00 +0000
Combining gemcitabine with MRK003, an experimental drug, triggers a chain of events leading to pancreatic cancer cell death, researchers from Cambridge reported in the Journal of Experimental Medicine. The researchers explained that when the two drugs are combined, the effect of each one is multiplied, thus intensifying the destruction of pancreatic cancer cells...
Implantable Microchip Delivers Medicine To Women With Osteoporosis
Sat, 18 Feb 2012 08:00:00 +0000
Osteoporosis patients could soon ditch daily injection pens for an implantable microchip that releases medication at the push of a remote-controlled button, reports a new study appearing in the journal Science Translational Medicine...
Helping Patients Tackle Geographic Challenges To Access Clinical Trials
Fri, 17 Feb 2012 09:00:00 +0000
As oncologists already know and newly diagnosed lung cancer patients learn, the kind of treatment given to patients is increasingly becoming dependent on the specific gene mutation present in the cancer...
Preventing 'Absence Seizures' In Children: New Drugs Show Promise
A team led by a University of British Columbia professor has developed a new class of drugs that completely suppress absence seizures - a brief, sudden loss of consciousness - in rats, and which are now being tested in humans. Absence seizures, also known as "petit mal seizures," are a symptom of epilepsy, most commonly experienced by children...
Bureaucracy May Be Putting Lives At Risk, Europe
Wed, 15 Feb 2012 12:00:00 +0000
A European Parliament event to discuss how EU legislation has negatively affected the treatment received by children and adolescents has marked International Childhood Cancer Day - 15th February...
Medical Researchers Discover 'Very Promising' Treatment For Huntington Disease
Wed, 15 Feb 2012 09:00:00 +0000
Medical researchers at the University of Alberta have discovered a promising new therapy for Huntington disease that restores lost motor skills and may delay or stop the progression of the disease based on lab model tests, says the lead researcher...
Brain MRIs May Provide An Early Diagnostic Marker For Dyslexia
Tue, 24 Jan 2012 10:00:00 +0000
Children at risk for dyslexia show differences in brain activity on MRI scans even before they begin learning to read, finds a study at Children's Hospital Boston. Since developmental dyslexia responds to early intervention, diagnosing children at risk before or during kindergarten could head off difficulties and frustration in school, the researchers say...
Human Hookworm Vaccine Trial
Fri, 20 Jan 2012 16:00:00 +0000
The Na-GST-1 antigen, a candidate for the first human hookworm vaccine developed by the Sabin Vaccine Institute (Sabin), has entered a Phase 1 human trial in Brazil, according to Sabin. For the vaccine product development partnership (PDP) headquartered at Sabin, the clinical trial is a considerable achievement. Worldwide, almost 600 million individuals are infected by human hookworm...
Impetigo - Ozenoxacin Phase lll Trial
The pharmaceutical company Ferrer has received approval to start phase III human trials of ozenoxacin, formulated as a topical treatment for infectious skin conditions. In February 2012, participants are expected to enter the multicenter, randomized, placebo controlled, parallel, double-blinded superiority clinical study, which is scheduled to complete in 2013...
New Drug For Advanced Colorectal Cancer Shows Promise In Trial
Wed, 18 Jan 2012 11:00:00 +0000
An experimental drug for advanced colorectal cancer that available treatments have failed to halt, has shown promise in a clinical trial, says Bayer HealthCare, the company that makes it. The results of the phase III trial show that compared to placebo, regorafenib slowed tumor growth and extended survival...
Medivation And Pfizer Axe their new Alzheimer's drug Dimebon
Tue, 17 Jan 2012 20:00:00 +0000
Pfizer Inc. and Medivation, Inc. announced results from their 'CONCERT' trial today. CONCERT is a Phase 3 trial that evaluated dimebon (latrepirdine), which is used to treat patients with mild-to-moderate Alzheimer's disease. Dimebon is added to ongoing treatment with donepezil HCL tablets...
Preoperative Breast Cancer Treatment May Be Improved By Combining 2 Anti-HER2 Drugs
Tue, 17 Jan 2012 10:00:00 +0000
Using two drugs that inhibit the growth factor HER2 for preoperative treatment of early-stage HER2-positive breast cancer appears to have better results than treatment with a single agent...
Research Misconduct Revealed in UK
Mon, 16 Jan 2012 18:00:00 +0000
A BMJ survey revealed that over one in ten (13%) UK based scientists or doctors have witnessed that colleagues intentionally changed or fabricated data during their research in order to get published, whilst 6% of respondents reported they are aware of possible research misconduct at their institution, that has not been accurately investigated...
In Ovarian Cancer, Faulty Proteins May Prove Significant In Identifying New Treatments
Mon, 16 Jan 2012 08:00:00 +0000
OHSU Knight Cancer Institute study results suggest that more patients than initially thought could potentially be treated with a new class of drugs, PARP inhibitors A constellation of defective proteins suspected in causing a malfunction in the body's ability to repair its own DNA could be the link scientists need to prove a new class of drugs will be effective in treating a...
Missing Data - A Serious Problem In Clinical Research
Fri, 06 Jan 2012 18:00:00 +0000
Missing data is a serious problem in clinical research given that it distorts the scientific record and prevents clinical decisions from being based on the best evidence available. As part of an in-depth BMJ review on the subject, experts on bmj.com warn that patients can be harmed through missing clinical trial data, leading to unnecessary costs to health systems...
Marinus Pharmaceuticals Experimental Epilepsy Treatment Shows Promise In Open-Label Extension Study
Sun, 01 Jan 2012 09:00:00 +0000
Marinus Pharmaceuticals, Inc., a specialty pharmaceutical company, announced that its neurosteroid ganaxolone which is currently under study for the treatment of partial onset seizures (POS), reported positive data in the open-label extension follow up to the company's Phase 2 clinical trial. The data reflects the replication of the effects seen in the double-blind study...
Human Trials Initiated For New HIV Vaccine
Sun, 01 Jan 2012 08:00:00 +0000
In the first clinical trial of an injectable vaccine containing trimeric HIV envelope protein (gp140) relevant to the predominant strain of HIV in Africa, researchers from four UK academic centers (St George's University London, Imperial College, Hull York Medical School (HYMS; University of York) and the Medical Research Council Clinical Trial Unit) and from the Infectious Dis...
Jennerex Announces First Patient Treated In Phase 2a Clinical Trial Of JX-594 As A Neoadjuvant Therapy In Colorectal Cancer
Jennerex, Inc., a private clinical-stage biotherapeutics company focused on the development and commercialization of first-in-class targeted oncolytic virus products for cancer, announced that the first patient has been treated in a Phase 2a clinical trial of JX-594 as a neoadjuvant therapy in patients who are undergoing surgery to treat colorectal cancer that has spread to the liver...
"Science" Names HIV Prevention Trial As Breakthrough Of The Year
Sat, 31 Dec 2011 08:00:00 +0000
Science named the HIV Prevention Trials Network (HPTN) 052 study "Breakthrough of the Year." FHI 360 congratulates our HPTN 052 collaborating partners on this important achievement. This is the second year in a row that Science selected a trial for which FHI 360 provided scientific leadership and operational support...
Abbott Initiates Clinical Trial To Study Drug Eluting Bioresorbable Therapy For Treatment Of Peripheral Artery Disease
Abbott (NYSE: ABT) announced the initiation of ESPRIT I, a first-of-its-kind clinical trial in Europe evaluating the safety and performance of the novel Esprit™ drug eluting bioresorbable vascular scaffold (BVS) for the treatment of blockages in the superficial femoral arteries (SFA) and iliac arteries that have resulted in claudication (leg pain upon walking)...
Denali Concrete Management Inc. Announces The Commencement Of Patient Enrollment For The Phase 3 Dry Eye Syndrome Study
Denali Concrete Management Inc. (OTCBB: DCMG) announced that it has commenced patient enrollment for a phase 3 clinical study of the safety and efficacy of CF101, daily administered orally, in patients with moderate-to-severe Dry Eye Syndrome. This multi-center clinical trial is conducted in the United States, Europe and Israel...
Neuralstem's NSI-189 Trial In Major Depressive Disorder Receives FDA Approval To Advance To Phase Ib
Thu, 29 Dec 2011 09:00:00 +0000
Neuralstem, Inc. (NYSE Amex: CUR) announced that it has been approved by the Food and Drug Administration to advance to Phase Ib in its ongoing clinical trial to test its novel neuroregenerative compound, NSI-189, for the treatment of major depressive disorder (MDD). Phase Ib will test the safety and tolerability of the drug in depressed patients...
Presentations Highlight Results Of Clinical Data For MLN8237 And VELCADE® In The Treatment Of Lymphoma
Fri, 23 Dec 2011 09:00:00 +0000
Millennium: The Takeda Oncology Company with its parent company Takeda Pharmaceutical Company Limited (TSE:4502) reported the presentation of results from a phase 2 trial evaluating MLN8237, an investigational inhibitor of Aurora A kinase, in patients with aggressive B-cell and T-cell non-Hodgkin lymphoma (NHL)...
Novartis Announces Termination Of ALTITUDE Study With Rasilez®/ Tekturna® In High-Risk Patients With Diabetes And Renal Impairment
Thu, 22 Dec 2011 09:00:00 +0000
Novartis announced that following the seventh interim review of data from the ALTITUDE study with Rasilez®/Tekturna® (aliskiren), a decision to terminate the trial has been taken on the recommendation of the independent Data Monitoring Committee (DMC) overseeing the trial...
