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Q: Do clinical trials ever go wrong?

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Prototype devices

It is recognized that a manufacturer may wish to submit a small number  of "prototype models" of a device to clinical investigation in order to assess safety and/or performance; and those such prototypes may need to undergo a number of changes prior to large-scale production.

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EFGCP–EUCROF Joint Workshop Final Report   by  on 2010-08-20 12:12:20
Managing Clinical Trials   by  on 2010-07-15 16:05:32
US-FDA issues Revised Info Sheet Guidance on Clinical Investigator Disqualification   by  on 2010-06-13 10:11:41
US-FDA issues final guidance on Statement of Investigator (Form FDA 1572)   by  on 2010-06-13 10:07:59
Rising Clinical Trial Complexity Continues to Vex Drug Developers   by  on 2010-06-03 09:36:33
Investigator-Driven Clinical Trials: An ESF Forward Look   by  on 2010-06-03 09:27:58
NIH's Financial Conflict of Interest (FCOI) Proposed Rule   by  on 2010-05-27 11:42:00
AAP’s Guidelines for the Ethical Conduct of Studies to Evaluate Drugs in Pediatric Population   by  on 2010-05-13 11:39:54
Argentina: ANMAT - new regulatory update   by  on 2010-05-01 01:40:32
The Wall Street Journal's special supplement on clinical trials   by  on 2010-05-01 01:31:52
Major developments in EU Clinical Trial Guidances   by  on 2010-04-20 19:10:55
Analysis of the adverse reactions induced by natural product-derived drugs   by  on 2010-04-18 23:16:06
Newer Antibacterial Drugs for a New Century   by  on 2010-04-18 22:49:47
Newer Non-Statin Drugs for Reducing Cholesterol   by  on 2010-04-13 07:57:20
Practice Guidelines for Chronic Pain Management   by  on 2010-04-04 20:52:16
CONSORT III (2010)   by  on 2010-03-29 12:53:28
US FDA Draft Guidance on Pharmacokinetics in Patients with Impaired Renal Function   by  on 2010-03-20 12:25:16
US-FDA issues First Draft Guidance on Noninferiority Trials   by  on 2010-03-04 14:07:46
US FDA new rule on reporting information regarding falsification of data   by  on 2010-02-25 20:47:33
US-FDA Guidance for the Use of Bayesian Statistics in Medical Device Clinical Trials   by  on 2010-02-06 12:12:14
UK-MHRA's Response to the Review of the Clinical Trials Directive   by  on 2010-01-27 11:19:01
US-FDA revised ICH Guidance:M3(R2) Nonclinical Safety Studies for Conduct of CT   by  on 2010-01-22 10:07:03
US-FDA Draft Guidance Recommends DSMBs, CECs for Heart Valve Studies   by  on 2010-01-21 11:22:51
FDA Issues Draft Guidance on IRB Continuing Review   by  on 2010-01-13 20:07:29
FDA's proposed rule on Post-marketing Safety Reporting for Combination Prodcuts   by  on 2010-01-12 12:15:13
PhRMA: More than 800 Medicines and Vaccines in Clinical Trials for Cancer   by  on 2010-01-10 20:23:31
PhRMA Report says 97 Medicines and Vaccines Now in Development for HIV/AIDS   by  on 2010-01-10 20:00:18
EMEA Guidelines on Cystic Fibrosis Drug Development   by  on 2010-01-05 09:14:16
US-FDA' proposed rule on Informed Consent regulations   by  on 2010-01-02 22:22:47
US FDA Warning Letters in Clinical Investigation for the Month of December 2009   by  on 2009-12-31 09:10:00
International Compilation of Human Research Protections 2010 Edition   by  on 2009-12-23 14:59:39
ASE Expert Consensus Statement: Echocardiographic Imaging in Clinical Trials   by  on 2009-12-17 20:11:05
USFDA's Final Guidance for Industry Patient-Reported Outcome Measures   by  on 2009-12-17 19:21:16
New Guidelines on Reporting Industry-Supported Clinical Trial Results: ISMPP   by  on 2009-12-04 18:55:35
Ethical Guidelines for Intervention Studies in New Zealand   by  on 2009-11-30 10:28:34
Medical Device Control Office, DOH, Hong Kong invites public comments on guidance   by  on 2009-11-21 07:57:50
Companies to Disclose All Clinical Trials in Patients   by  on 2009-11-19 09:25:20
Office for Human Research Protections (OHRP): Requests for Public Comment   by  on 2009-11-09 09:38:15
HL7 Announces Industry’s First EHR-S Functional Requirements Standard for Clinical Research   by  on 2009-11-08 22:28:30
PhRMA's New Clinical Trial Guidelines   by  on 2009-10-05 10:21:30
 Subject :Re:Interview Tips: Sample Questions and Answers: Part 2.. 2012-08-31 07:48:02 
william
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Topic : Interview Tips: Sample Questions and Answers: Part 2

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 Subject :Re:Argentina: ANMAT - new regulatory update.. 2012-08-31 07:44:05 
william
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Forum : Ethics, GCP, Quality Assurance and Regulatory Affairs
Topic : Argentina: ANMAT - new regulatory update

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 Subject :Effectiveness of Chiropractic Care.. 2012-03-16 00:43:41 
William Jimenez
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Topic : Effectiveness of Chiropractic Care

“Landmark Studies on the effectiveness of chiropractic”.

 

§  Australian research shows it helps low back pain.

§   New Zealand inquiry proves its incredible safety record.

§  Danish study shows it cures colic in over 90% of cases.

§  Canadian Government study proves it is cost effective.

§  American Government study highly endorses it.

§  British study proves its results are long lasting.

§  West German study reveals it helps headaches.

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 Subject :Cancer Theranostics - Potential Applications of Cancer Biomarker Datab.. 2012-01-16 12:45:14 
Tonny Johnson
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Cancer Theranostics - Potential Applications of Cancer Biomarker Database

Subject :Cancer Theranostics - Potential Applications of Cancer Biomarker Database

This blog analyzes the potential applications of biomarkers in cancer theranostics (Rx/Dx), a diagnostic therapy process that leads to the development of successful personalized medicine strategies in cancer treatment. Please follow this ink to read this blog: http://tinyurl.com/7f6s2y9
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 Subject :Cell Based Reporter Assays vs. Animal Studies in Drug Discovery .. 2012-01-16 12:43:43 
Tonny Johnson
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Cell Based Reporter Assays vs. Animal Studies in Drug Discovery

Cell Based Reporter Assays vs. Animal Studies in Drug Discovery- Potential Limitations, Risks and Liabilities

This blog critically analyzes the potential scientific limitations, risks and liabilities of cell based reporter assays, including non-natural protein based reporter assays (e.g. circularly permuted firefly luciferase or GFP based reporter assays) and stem cell based assays, in drug discovery and development.  Scientific arguments have been put forward to suggest that current format of cell based reporter assays may not be ideal for replacing animal studies. This blog also analyzes the potential negative impact of patents and intellectual property (IP) rights in fostering innovations in cell based assays. Finally, this blog warrants imposing accountability, tighter regulations and demanding higher standards in cell based assays that are used in drug discovery and development. Please follow this link to read the full blog article: http://sciclips.wordpress.com/2012/01/16/cell-based-reporter-assays-vs-animal-studies-in-drug-discovery-potential-limitations-risks-and-liabilities/

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 Subject :Re:Managing Clinical Trials.. 2011-12-26 17:18:25 
Dino Brand
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Topic : Managing Clinical Trials

Trial managers should be involved early on in the trial design phase, but this is rarely possible because of funding constraints.
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Last Edited On: 2011-12-26 17:18:25 By Dino Brand for the Reason
Low T
 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-12-13 10:43:39 
William Cron
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Topic : Argentina: ANMAT - new regulatory update

Regulatory issues results due to error on behalf of the accused and the resources mentioned above helped in sorting them.

 

VPN mobile

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Last Edited On: 2011-12-13 10:43:39 By William Cron for the Reason
 Subject :Re:Argentina: ANMAT - new regulatory update.. 2011-10-28 15:27:30 
Vishnu
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Topic : Argentina: ANMAT - new regulatory update

The resource is very useful for regulatory issues
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 Subject :Diagnostic and prognostic biomarker database launched.. 2011-03-24 20:12:55 
Tonny Johnson
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Diagnostic and prognostic biomarker database launched

We have launched a unique biomarker database that contains more than 29,000 unique biomarkers (for more than 1800 human diseases), which are manually extracted from patent publications and PubMed abstracts.  This database contains biomarkers of diverse nature such as:
1) Drug efficacy/response biomarkers (7708 unique biomarkers)
2) Disease risk assessment and predictive biomarkers (10,375 unique biomarkers)
3) Protein/peptide/antibody biomarkers (7279 unique biomarkers)
4) Molecular diagnostic biomarkers, including gene/gene expression biomarkers, polymporphisms/SNP biomarkers (including linkage disequilibrium biomarkers) (7206 unique biomarkers)
5) Metabolomic biomarkers (811 unique biomarkers)
6) MicroRNA (miRNA) biomarkers (935 unique biomarkers)
7) Epigenetic biomarkers (700 unique biomarkers)

Please follow this link to access our database: http://www.sciclips.com/sciclips/diagnostic-biomarker-prognostic-biomarker-db.do 
 
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 Subject :Are stem cells ready as a next generation drug discovery tool?.. 2010-12-17 07:47:48 
Tonny Johnson
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Forum : Drug Discovery
Topic : Are stem cells ready as a next generation drug discovery tool?

This Wordpress blog analyzes possible limitations of stem cell derived products in drug discovery research and development. We also argue for the need to create a regulatory system for drug screening assays. Link: http://tinyurl.com/2c8uo78

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 Subject :Visualisation of trials, sites & patient recruitment, 2005-09.. 2010-12-07 09:13:57 
Leon
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Topic : Visualisation of trials, sites & patient recruitment, 2005-09

Dear Friends,

Outsourcing-Pharma presents an interactive visualisation of clinical trial data submitted to the EMA in MAA from 2005-09, showing the number of trials, sites and patients from each country. Globalisation of clinical trials prompted the European Medicines Agency (EMA) to collect data about where pivotal studies included in marketing authorisation applications (MAA) were performed. This data was published in an EMA report and collated by Outsourcing-Pharma .

Click here to see this visualization.

Kind regards,

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 Subject :Clinical trials submitted in marketing authorisation applications to t.. 2010-12-07 09:08:58 
Harrison
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Forum : Clinical Operations
Topic : Clinical trials submitted in marketing authorisation applications to the EMA

Subject :Clinical trials submitted in marketing authorisation applications to the EMA

Dear friends,

Please find attached EMA report: Clinical trials submitted in marketing authorisation applications to the EMA.

The revisions to the pharmaceutical legislation which came into force in 2005 increased emphasis on the ethical standards required of clinical trials conducted in third countries and included in marketing authorisation Applications (MAAs) submitted in the EU. There is growing concern both among regulators and in public debate about how well these trials are conducted from an ethical and scientific/organisational standpoint, including good clinical practice (GCP) compliance and about the available framework for the supervision of these trials. Information is required in each MAA regarding the location of conduct and ethical standards applied in respect of clinical trials conducted in third countries.

Information on the geographic origins of patients recruited in the pivotal trials included in MAAs submitted to the centralised procedure has been collected since mid 2004. This report provides an overview of the distribution of the number of patients, investigator sites and pivotal clinical trials included in MAAs submitted to the EMA, on the number of sites subject to inspection and the geographic location of these inspections. This report was first published in 2009 with the data from MAAs submitted between 2005 to 2008. This second report is an update adding data from MAAs submitted in 2009.

Kind regards,


Attachments
 WC500016819.pdf [484 KB] ::
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Last Edited On: 2010-12-07 09:08:58 By Harrison for the Reason
 Subject :Do Medications Really Expire? .. 2010-11-11 09:49:51 
Harrison
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Topic : Do Medications Really Expire?

By Richard Altschuler
Does the expiration date on a bottle of a medication mean anything? If a bottle of Tylenol, for example, says something like "Do not use after June 1998," and it is August 2002, should you take the Tylenol? Should you discard it? Can you get hurt if you take it? Will it simply have lost its potency and do you no good?
In other words, are drug manufacturers being honest with us when they put an expiration date on their medications, or is the practice of dating just another drug industry scam, to get us to buy new medications when the old ones that purportedly have "expired" are still perfectly good?
These are the pressing questions I investigated after my mother-in-law recently said to me, "It doesn't mean anything," when I pointed out that the Tylenol she was about to take had "expired" 4 years and a few months ago. I was a bit mocking in my pronouncement -- feeling superior that I had noticed the chemical corpse in her cabinet -- but she was equally adamant in her reply, and is generally very sage about medical issues.
So I gave her a glass of water with the purportedly "dead" drug, of which she took 2 capsules for a pain in the upper back. About a half hour later she reported the pain seemed to have eased up a bit. I said "You could be having a placebo effect," not wanting to simply concede she was right about the drug, and also not actually knowing what I was talking about. I was just happy to hear that her pain had eased, even before we had our evening cocktails and hot tub dip (we were in "Leisure World," near Laguna Beach, California, where the hot tub is bigger than most Manhattan apartments, and "Heaven," as generally portrayed, would be raucous by comparison).
Upon my return to NYC and high-speed connection, I immediately scoured the medical databases and general literature for the answer to my question about drug expiration labeling. And voila, no sooner than I could say "Screwed again by the pharmaceutical industry," I had my answer. Here are the simple facts:
First, the expiration date, required by law in the United States, beginning in 1979, specifies only the date the manufacturer guarantees the full potency and safety of the drug -- it does not mean how long the drug is actually "good" or safe to use.
Second, medical authorities uniformly say it is safe to take drugs past their expiration date -- no matter how "expired" the drugs purportedly are. Except for possibly the rarest of exceptions, you won't get hurt and you certainly won't get killed.
A contested example of a rare exception is a case of renal tubular damage purportedly caused by expired tetracycline (reported by G. W. Frimpter and colleagues in JAMA, 1963;184:111) . This outcome (disputed by other scientists) was supposedly caused by a chemical transformation of the active ingredient. Third, studies show that expired drugs may lose some of their potency over time, from as little as 5% or less to 50% or more (though usually much less than the latter). Even 10 years after the "expiration date," most drugs have a good deal of their original potency. So wisdom dictates that if your life does depend on an expired drug, and you must have 100% or so of its original strength, you should probably toss it and get a refill, in accordance with the cliché, "better safe than sorry." If your life does not depend on an expired drug -- such as that for headache, hay fever, or menstrual cramps -- take it and see what happens.
One of the largest studies ever conducted that supports the above points about "expired drug" labeling was done by the US military 15 years ago, according to a feature story in the Wall Street Journal (March 29, 2000), reported by Laurie P. Cohen. The military was sitting on a $1 billion stockpile of drugs and facing the daunting process of destroying and replacing its supply every 2 to 3 years, so it began a testing program to see if it could extend the life of its inventory. The testing, conducted by the US Food and Drug Administration (FDA), ultimately covered more than 100 drugs, prescription and over-the-counter. The results showed that about 90% of them were safe and effective as far as 15 years past their original expiration date.
In light of these results, a former director of the testing program, Francis Flaherty, said he concluded that expiration dates put on by manufacturers typically have no bearing on whether a drug is usable for longer. Mr. Flaherty noted that a drug maker is required to prove only that a drug is still good on whatever expiration date the company chooses to set. The expiration date doesn't mean, or even suggest, that the drug will stop being effective after that, nor that it will become harmful. "Manufacturers put expiration dates on for marketing, rather than scientific, reasons," said Mr. Flaherty, a pharmacist at the FDA until his retirement in 1999. "It's not profitable for them to have products on a shelf for 10 years. They want turnover."
The FDA cautioned there isn't enough evidence from the program, which is weighted toward drugs used during combat, to conclude most drugs in consumers' medicine cabinets are potent beyond the expiration date. Joel Davis, however, a former FDA expiration-date compliance chief, said that with a handful of exceptions -- notably nitroglycerin, insulin, and some liquid antibiotics -- most drugs are probably as durable as those the agency has tested for the military. "Most drugs degrade very slowly," he said. "In all likelihood, you can take a product you have at home and keep it for many years, especially if it's in the refrigerator. " Consider aspirin. Bayer AG puts 2-year or 3-year dates on aspirin and says that it should be discarded after that. However, Chris Allen, a vice president at the Bayer unit that makes aspirin, said the dating is "pretty conservative" ; when Bayer has tested 4-year-old aspirin, it remained 100% effective, he said. So why doesn't Bayer set a 4-year expiration date? Because the company often changes packaging, and it undertakes "continuous improvement programs," Mr. Allen said. Each change triggers a need for more expiration-date testing, and testing each time for a 4-year life would be impractical. Bayer has never tested aspirin beyond 4 years, Mr. Allen said. But Jens Carstensen has. Dr. Carstensen, professor emeritus at the University of Wisconsin's pharmacy school, who wrote what is considered the main text on drug stability, said, "I did a study of different aspirins, and after 5 years, Bayer was still excellent. Aspirin, if made correctly, is very stable.
Okay, I concede. My mother-in-law was right, once again. And I was wrong, once again, and with a wiseacre attitude to boot. Sorry mom.
Now I think I'll take a swig of the 10-year dead package of Alka Seltzer in my medicine chest -- to ease the nausea I'm feeling from calculating how many billions of dollars the pharmaceutical industry bilks out of unknowing consumers every year who discard perfectly good drugs and buy new ones because they trust the industry's "expiration date labeling."
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Last Edited On: 2010-11-11 09:49:51 By Harrison for the Reason
 Subject :Designing clinical trials of molecular targeted therapy for hepatocell.. 2010-11-10 15:18:22 
Leon
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Topic : Designing clinical trials of molecular targeted therapy for hepatocellular carcinoma

Subject :Designing clinical trials of molecular targeted therapy for hepatocellular carcinoma

Dear All,

Please find attached article: Eastern Asian expert panel opinion: designing clinical trials of molecular targeted therapy for hepatocellular carcinoma,

Kind regards,


Attachments
 DesignHCC.pdf [164 KB] ::
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 Subject :Cell based reporter assays: misleading approach in drug discovery?.. 2010-11-10 01:27:28 
Tonny Johnson
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Forum : Drug Discovery
Topic : Cell based reporter assays: misleading approach in drug discovery?

Blog article: Cell based reporter assays: misleading approach in drug discovery?

This blog analyzes potential pitfalls associated with homogeneous and cell based reporter assays used in pre-clinical drug discovery research. Link: http://sciclips.wordpress.com/
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 Subject :Open access therapeutic drug targets database.. 2010-11-10 01:25:32 
Tonny Johnson
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Topic : Open access therapeutic drug targets database

A comprehensive database of therapeutic drug targets extracted from patents or patent applications – an open innovation initiative by Sciclips. This database contains drug targets reported in US patents or US/International patent applications. The drug targets are classified according to specific drug types (e.g. small molecule drugs, protein drugs, antibody drugs, siRNA drugs, miRNA drugs etc.) and disease types. The assays and methods used for characterizing each drug targets are listed as well. In addition to this, all the drug targets are linked to PubMed, Google Scholar, GeneBank, UniProt, USPTO database, WO(PCT) database and Google Patents.Link: http://www.sciclips.com/sciclips/drug-targets-all.do
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 Subject :Neuropeptide & Sigma Receptors as Novel Therapeutic Targets for th.. 2010-11-09 12:29:37 
Harrison
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : Neuropeptide & Sigma Receptors as Novel Therapeutic Targets for the Pharmacotherapy of Depression

Subject :Neuropeptide & Sigma Receptors as Novel Therapeutic Targets for the Pharmacotherapy of Depression

Dear Friends,

Please find attached article on Neuropeptide and Sigma Receptors as Novel Therapeutic Targets for the Pharmacotherapy of Depression.

Kind regards,


Attachments
 depression.pdf [351 KB] ::
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 Subject :New anticoagulants for the prevention of venous thromboembolism.. 2010-11-09 12:25:58 
Harrison
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : New anticoagulants for the prevention of venous thromboembolism

Dear Friends,

Please find attached article on new anticoagulants for venous thromboembolism.

Kind regards,


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 Subject :World First Stem Cell Clinical Trial: Q & A with Johns Hopkin's St.. 2010-10-13 16:07:12 
Leon
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Topic : World First Stem Cell Clinical Trial: Q & A with Johns Hopkin's Stem Cell Expert Candace Kerr

Subject :World First Stem Cell Clinical Trial: Q & A with Johns Hopkin's Stem Cell Expert Candace Kerr

  1. What would you tell spinal cord patients about news that a safety study looking at human embryonic stem cells has started? Is this good news?
    This trial is a pivotal step forward for understanding how human embryonic stem cells will be able to treat patients with SCI. Importantly, patients should expect that this is just a first step of many that will be required for such a consuming affliction.
  2. How promising is the approach that Geron reports in this trial? What are key hurdles or challenges it might face from your viewpoint? What approaches do you see as more, or equally, promising?
    It is critical that this trial will test for the first time how human derived stem cells behave in patients. Without knowing the specifics it still appears that cell tracking and cell function will be difficult to determine in live patients. These features will be important to assess whether injected cells move out of the spinal cord or whether they replace and perform the function of the cells damaged by SCI. For instance, many ongoing clinical trials with human mesenchymal stem cells have shown short-term improvement only, and that the improvement is caused by factors the injected cells secrete that help in the recovery of the patient's own tissue or by reducing damage caused by inflammatory responses from the immune system.
  3. What would you tell patients who want to explore a clinical trial such as this one?
    Patients should go into these trials understanding that its purpose is to determine whether the transplantations are safe. The purpose of Geron's animal trials where these cells were tested for FDA approval would have included studying any adverse effects. Main adverse effects would be uncontrolled growth of cells which may lead to tumors or movement of the transplanted cells out of the spinal cord into other areas of the body. In addition, patients would need to understand that they may not see any immediate benefits or recovery, while nonetheless, these trials will provide invaluable information that will pioneer the field of stem cell based therapies. Not just SCI but for other neurological disorders like MS and ALS, where these cells also play a significant role in the disease.
  4. Is it worth reporting the news, or it is unfairly raising expectations just to report it? Why, or why not?
    I do not believe you will be able to ignore this story as it unfolds as many are anticipating a significant outcome from this trial. Whether justifiably so or not, this trial will put the clinical utility of these cells in perspective for not just SCI but for other afflictions, as well. Many believe that until we can show clinical benefit of these cells, their utility and justification for studying them will constantly be under public scrutiny and skepticism. It is important to understand that the purpose of this trial is safety. So what does that really mean? The patients receiving treatment for this trial have the most severe levels of SCI in which they have complete loss of functional and sensory output in the lower torso. Thus, the level of damage may be so severe that the strategy as it is tested for the first time in this trial may not overcome all the obstacles associated with such severe injury or that only minor recovery is achieved. If this occurs the greatest injustice will be to report that the cells do not work. I think this is where scientists are holding their breath, that "what if" lack of improvement will be reported and seen by the public as a failure. This may not be the case at all in that it may significantly improve less severe levels of injury or with improvements in the implementation of the cell based strategy along with other drugs this may produce improved outcomes in further studies.
  5. Are there any key points, or other information worth noting, in a news report about this? Geron's position in the hESC universe has always been interesting to people in the field, but not something the general reader can appreciate, for example.
    Geron's investment in making this clinical trial happen attests to the importance of government funding to support this type of research. For instance, only a handful of laboratories, including our own have demonstrated the ability to generate this specific cell type used in Geron's trial from human embryonic stem cells. Therefore, it is essential that federal funding remain an integral part of supporting the endeavors of nonprofit institutions to study how to grow and to generate the specific cell types from human embryonic stem cells.
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Last Edited On: 2010-10-13 16:07:12 By Leon for the Reason
 Subject :New atypical antipsychotics for schizophrenia: Iloperidone.. 2010-10-13 15:49:28 
Harrison
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Forum : Medicine, Pharmacology & Therapeutics updates
Topic : New atypical antipsychotics for schizophrenia: Iloperidone

Dear friends,

Please find attached article on New atypical antipsychotics for schizophrenia: Iloperidone.

Kind regards,


Attachments
 Iloperidone.pdf [508 KB] ::
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