RECENT NEWS
FierceBiotech  8 hrs ago  Comment 
Amid a continental push to make more clinical trial results available to the public, the European Medicines Agency has apparently assuaged a former foe in AbbVie, as the drugmaker dropped a lawsuit designed to block the release of data on its...
DailyFinance  12 hrs ago  Comment 
PORTLAND, OR and CAMBRIDGE, MA -- (Marketwired) -- 04/04/14 -- MolecularMD, Inc., a molecular diagnostics company that provides custom companion diagnostic solutions and supporting clinical trial services for targeted cancer therapies, today...
MedPage Today  Apr 3  Comment 
WASHINGTON (MedPage Today) -- Real-world results with transcatheter aortic valve implantation (TAVI) have been holding up compared with clinical trials, a national registry showed.
guardian.co.uk  Apr 2  Comment 
Company stops high profile clinical trial for Mage-A3 after lack of progress GlaxoSmithKline has slipped back after another drug disappointment. The company has stopped a high profile clinical trial using the Mage-A3 vaccine to treat lung cancer,...
New York Times  Apr 1  Comment 
The product, called Afrezza, would offer people with diabetes a treatment option that does not require injections, although its success in clinical trials has been modest at best.     
MedPage Today  Apr 1  Comment 
(MedPage Today) -- A mobile application (KUDL) delivered promising results for reducing feelings of isolation, weirdness, and the need for social engagement in phase III clinical trials, researchers report in this exclusive MedPage Today video.
FierceBiotech  Apr 1  Comment 
Results from a clinical trial of 59 patients with chronic ischemic heart disease and severe heart failure found that a new stem cell treatment improved heart pump function compared to the placebo group.
DailyFinance  Apr 1  Comment 
PLANO, TX -- (Marketwired) -- 04/01/14 -- Polaris International Holdings, Inc. (OTC Pink: PIHN) (PINKSHEETS: PIHN) is pleased to announce the Company has added Dr. Vasthi Alvarez Avila as Medical Director and to the Corporate Board of Directors....
DailyFinance  Mar 31  Comment 
JERSEY CITY, NJ -- (Marketwired) -- 03/31/14 -- QualityHealth ( www.QHperform.com), the largest digital patient identification and engagement platform for health products and services, today announced an expansion of its clinical trial...
Forbes  Mar 31  Comment 
A large clinical trial testing a novel compound from Novartis for chronic heart failure has been stopped early for efficacy. In a press release Novartis said the Data Monitoring Committee had recommended early closure of the PARADIGM-HF...




 
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Clinical trials are the process by which a new drug's safety and effectiveness are tested as part of the FDA approval process. When a company discovers and develops a new drug, they must first run extensive pre-clinical trials prior to testing the drug candidate on people. This pre-clinical development process serves to determine a drug's safety, the best starting dose for human clinical trials, and the interaction between the body and the drug. Once pharmaceutical companies have enough information about the drug, they can apply for approval to run clinical trials on humans.

Companies impacted by clinical trials

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Development pipeline for major pharmaceutical companies

Pharmaceutical companies

Clinical trials can only come after extensive pre-clinical testing and development, which can be costly. Additionally, clinical trials themselves are very expensive to conduct. If a company's drug reaches a late-stage clinical trial and fails, the money spent up until that point will be lost. Any pharmaceutical company involved in the development of new drugs can be significantly impacted by the results of clinical trials, either positively or negatively.

Major pharmaceutical companies include:

As shown in the graph, these companies have anywhere from 20 to 140 new products in various stages of development. In general, Phase II is the most common place for drug candidates to fail. As such, companies with a higher percentage of products that either are in Phase III clinical trials or for which they've already filed a new drug application (NDA) are at somewhat lower risk of failing a clinical trial.

Manufacturers of medical equipment, such as Advanced Medical Optics, are impacted by clinical trials as well.

Clinical testing process

    • After a dClinical trials are generally divided into four phases, though the FDA did establish a new Phase 0 designation for initial human trials. Including this recent addition, the five phases of clinical trials are:
  • Phase 0
    • This phase is aimed at determining whether a drug will behave in humans in the way that pre-clinical testing indicated. A small dosage, below the amount expected to be used therapeutically, is given to a small number of subjects to determine if the drug will act on the part of the body on which it was designed to act. For example, a drug designed to lower cholesterol would be tested to see if it acts on particular parts of the body (blood vessels, the heart, etc.) and to see if that interaction is in line with expectations. This can prevent further, unnecessary testing in the event of a drug's not acting as predicted.
  • Phase I
    • This is the first major stage in the clinical testing process. The drug is administered to a small group of subjects in an inpatient clinic, where the subjects can be monitored constantly. The main purpose of Phase I trials are to determine several things about a drug candidate, including its toxicity, side effects, interaction with the body, and proper dosage levels. There are a few different types of Phase I trials, but the basic premise is that the subjects receive an increasing dosage of the drug while being monitored for side effects. Other factors are also tested, such as the impact of food consumption on the drug's effectiveness,
  • Phase IIrug's initial safety has been established, Phase II trials are commenced. In this stage, the drug is administered to a larger group of people, allowing further study of a candidate's effectiveness. Phase II trials also continue the safety assessments started in Phase I. The main purpose, however, is to determine a drug's efficacy, or whether its effect on the body is significant enough to warrant further testing.
  • Phase III
    • Phase III trials are generally the last stop on a drug's way from the lab to the pharmacy. These trials involve large subject groups and are designed to be the final assessment of a drug's efficacy and side effects. Phase III trials go one step further by comparing the drug candidate to the current standard treatment for a particular condition. If a drug is effective but shows no significant benefits over a treatment already in use, it can still be approved for production, though sales might not be as high as its developer had hoped. In the news, a drug that is proven to be safe and effective but that doesn't offer any advantages over the current "gold standard" treatment is often said to have "failed" the Phase III trials. While this something of a misnomer, it reflects the importance for pharmaceutical companies to develop innovative drugs that improve on existing treatment options.
  • Phase IV
    • Phase IV clinical trials occur after the approval and release of a new drug. These trials, which are sometimes not required, are used to further understand a drug's mechanism of action. For example, Phase IV trials often test the drug's interactions with other drugs and its effectiveness in certain populations that were not present in previous clinical trials. Additionally, drugs in this phase are monitored for long-term side effects that clinical trials were unable to detect. This can be important, since the relatively short duration of the clinical testing process doesn't allow for the observance of a drug's long-term impact on subjects. Vioxx, the blockbuster osteoarthritis drug made by Merck (MRK), is a well-known example of a drug recalled as a result of continual monitoring for safety.
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