Forbes  6 hrs ago  Comment 
When lawmakers demagogue the price issue alone with talk of price caps and controls, markets crash, money for innovative cures dries up, clinical trials get pushed off, and people waiting for cures actually die.
Benzinga  11 hrs ago  Comment 
Celsion Corporation (Celsion) (NASDAQ: CLSN), a fully-integrated oncology company focused on the development of a portfolio of innovative cancer treatments, including directed chemotherapies, immunotherapies and RNA- or DNA-based therapies for the...
Benzinga  11 hrs ago  Comment 
Zogenix, Inc. (Nasdaq: ZGNX), a pharmaceutical company developing therapies for the treatment of central nervous system (CNS) disorders, today announced positive top-line pharmacokinetic results from its Phase 1b multi-dose clinical trial of...  12 hrs ago  Comment 
SUMMIT THERAPEUTICS PRESENTS ADDITIONAL DATA FROM PHASE 1B MODIFIED DIET CLINICAL TRIAL OF SMT C1100 IN DMD PATIENTS AT WMS * 10 of 12 Patients Achieved Plasma Concentrations Expected to Increase Utrophin Levels by Approximately 30% or...
Benzinga  12 hrs ago  Comment 
Trillium Therapeutics Inc. (NASDAQ: TRIL)(TSX: TR), an immuno-oncology company developing innovative therapies for the treatment of cancer, today announced that it has completed the manufacture of clinical-grade drug product, concluded a...
Benzinga  12 hrs ago  Comment 
Galena Biopharma, Inc. (NASDAQ: GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology therapeutics that address major medical needs across the full spectrum of cancer care, today announced a collaboration...
Benzinga  12 hrs ago  Comment 
Cerulean Pharma Inc. (Nasdaq: CERU), a clinical stage company developing nanoparticle-drug conjugates (NDCs), today announced that CRLX101 has achieved the pre-defined, gating criterion for advancement into stage two of an open label, single-arm...
Benzinga  12 hrs ago  Comment 
OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) announced today that Borealis-2™, an investigator-sponsored, randomized Phase 2 trial, has met its target enrollment of 200 patients. Designed to evaluate apatorsen in combination with docetaxel in...
Benzinga  12 hrs ago  Comment 
Bellerophon Therapeutics, Inc. (Nasdaq: BLPH), a clinical-stage biotherapeutics company, announced that an oral presentation of late-breaking data from a clinical trial sponsored by the Company was presented today at the European Respiratory...  Sep 30  Comment 
INDIANAPOLIS (dpa-AFX) - Adocia and Eli Lilly and Co. (LLY) announced the initiation of a Phase 1b clinical trial evaluating BioChaperone Lispro, an ultra-rapid formulation of insulin lispro licensed to Lilly. This formulation uses Adocia's...


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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