RECENT NEWS
The Economic Times  Aug 11  Comment 
The health ministry notified that an investigator can handle as many clinical trials as approved by the Ethics Committee—a reversal from an earlier order.
Forbes  Aug 11  Comment 
Cutting-edge genetic science is speeding and improving clinical trials.
The Economic Times  Aug 10  Comment 
Ethics committee, registered with DCGI according to the Drugs & Cosmetics Rules, can also decide whether a site is suitable for conducting these procedures.
newratings.com  Aug 10  Comment 
JERUSALEM (dpa-AFX) - Shares of Protalix BioTherapeutics, Inc. (PLX) are gaining around 9 percent in pre-market activity on the NYSE after the company announced Wednesday additional positive data from its phase I/II clinical trial of PRX-102 for...
Benzinga  Aug 9  Comment 
Morgan Stanley provided its outlook on Akebia Therapeutics Inc (NASDAQ: AKBA) in a report published Tuesday. The company posted its Q2 results and announced the initiation of the Phase 3 clinical trials for vadadustat in dialysis. The Phase 3,...
Benzinga  Aug 8  Comment 
Deutsche Bank has cut its estimates and price target on Bristol-Myers Squibb Co (NYSE: BMY) shares following its clinical trial disappointment. Bristol-Myers said on Friday that its CheckMate-026 Study, which was investigating the use of Opdivo...
Forbes  Aug 8  Comment 
Merck clearly took the safer route with its NSCLC clinical trial design with Keytruda by selecting a subset of patients most likely to benefit from its drug. But, from a scientific standpoint, the BMS study has importantly contributed to the body...
New York Times  Aug 5  Comment 
Bristol-Myers Squibb said the drug had not slowed the progression of advanced lung cancer in a test seeking approval to use it as an initial treatment.
Wall Street Journal  Aug 5  Comment 
Bristol-Myers’s stock stumble after a surprise clinical trial failure and the collapse of Valeant’s shares show there’s no avoiding risks in drug development.
Forbes  Aug 5  Comment 
A significant number of pediatric clinical trials are either stopped before they’re completed, or if completed, their results go unpublished.




 
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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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