RECENT NEWS
MedPage Today  12 hrs ago  Comment 
WASHINGTON (MedPage Today) -- The FDA is trying to increase representation of women and minorities in clinical trials, but observers said the agency's latest effort in this area is not sufficient.
SeekingAlpha  Aug 25  Comment 
By Alexander Maxwell: For many biotechnology stocks, clinical trial results are one of the biggest catalysts available. They represent the culmination of years of hard work and millions of dollars in research and development costs. For investors,...
newratings.com  Aug 25  Comment 
WHITEHOUSE STATION (dpa-AFX) - Advaxis Inc. (ADXSW, ADXS), a clinical-stage biotechnology company developing cancer immunotherapies, Monday said it has entered into a clinical trial collaboration agreement with drugmaker Merck (MRK) through its...
SeekingAlpha  Aug 19  Comment 
By Christopher F. Davis: As a PhD-level epidemiologist and market analyst, there is no sector more interesting to me than biotech. I have opined on several of these names in the past. Those of you who follow my work know that I search for...
FierceBiotech  Aug 19  Comment 
Tecemotide, Merck KGaA's 9-lived cancer vaccine, has flunked another clinical trial, missing its main goal in a Japanese study and casting further doubts on the program's future.
DailyFinance  Aug 19  Comment 
BEVERLY, MA -- (Marketwired) -- 08/19/14 -- Cellceutix Corporation (OTCQB: CTIX) (the "Company"), a clinical stage biopharmaceutical company developing innovative therapies in oncology, dermatology, and antibiotic applications, has announced the...
Benzinga  Aug 18  Comment 
ARCA biopharma, Inc. (Nasdaq: ABIO), a biopharmaceutical company developing genetically targeted therapies for cardiovascular diseases, today announced that the Company's Clinical Trial Application (CTA) for the GENETIC-AF clinical trial...
SeekingAlpha  Aug 15  Comment 
By Curve Tech Investing: Three recent articles in Seeking Alpha have described the medical advantages of Revolixys, the uncertainty of the future for Revolixys due to a hold on the current Phase III clinical trial, and the opportunity that Regado...
Wall Street Journal  Aug 13  Comment 
Amgen Inc. and its subsidiary Onyx Pharmaceuticals said their Kyprolis cancer drug failed to meet its primary endpoint of improving overall survival for patients with relapsed multiple myeloma in a late-stage clinical trial.
SeekingAlpha  Aug 13  Comment 
By Smith On Stocks: What a Data Monitoring Committee Does With each clinical trial, an independent committee is formed to monitor the conduct and progression of the trial and to determine if there are any safety or efficacy issues that might...




 
TOP CONTRIBUTORS

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

Error creating thumbnail
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.
Wikinvest © 2006, 2007, 2008, 2009, 2010, 2011, 2012. Use of this site is subject to express Terms of Service, Privacy Policy, and Disclaimer. By continuing past this page, you agree to abide by these terms. Any information provided by Wikinvest, including but not limited to company data, competitors, business analysis, market share, sales revenues and other operating metrics, earnings call analysis, conference call transcripts, industry information, or price targets should not be construed as research, trading tips or recommendations, or investment advice and is provided with no warrants as to its accuracy. Stock market data, including US and International equity symbols, stock quotes, share prices, earnings ratios, and other fundamental data is provided by data partners. Stock market quotes delayed at least 15 minutes for NASDAQ, 20 mins for NYSE and AMEX. Market data by Xignite. See data providers for more details. Company names, products, services and branding cited herein may be trademarks or registered trademarks of their respective owners. The use of trademarks or service marks of another is not a representation that the other is affiliated with, sponsors, is sponsored by, endorses, or is endorsed by Wikinvest.
Powered by MediaWiki