8/13/2023 0 Comments Merck inform edc![]() ![]() ![]() Pilot experiments are conducted to gain insights for design of the clinical trial to follow. Other clinical trials pertain to people with specific health conditions who are willing to try an experimental treatment. Some clinical trials involve healthy subjects with no pre-existing medical conditions. ![]() Only 10 percent of all drugs started in human clinical trials become approved drugs. Certain functions necessary to the trial, such as monitoring and lab work, may be managed by an outsourced partner, such as a contract research organization or a central laboratory. The sponsor may be a governmental organization or a pharmaceutical, biotechnology or medical device company. Clinical study design aims to ensure the scientific validity and reproducibility of the results.Ĭosts for clinical trials can range into the billions of dollars per approved drug. Clinical trials can vary in size and cost, and they can involve a single research center or multiple centers, in one country or in multiple countries. These authorities are responsible for vetting the risk/benefit ratio of the trial-their approval does not mean the therapy is 'safe' or effective, only that the trial may be conducted.ĭepending on product type and development stage, investigators initially enroll volunteers or patients into small pilot studies, and subsequently conduct progressively larger scale comparative studies. They are conducted only after they have received health authority/ethics committee approval in the country where approval of the therapy is sought. Clinical trials generate data on dosage, safety and efficacy. Consequently, the company will not update the information contained in the website and investors should not rely upon the information as current or accurate after the presentation date.A clinical trial participant receives an injection.Ĭlinical trials are prospective biomedical or behavioral research studies on human participants designed to answer specific questions about biomedical or behavioral interventions, including new treatments (such as novel vaccines, drugs, dietary choices, dietary supplements, and medical devices) and known interventions that warrant further study and comparison. The company assumes no duty to update the information to reflect subsequent developments. The information contained in this website was current as of the date presented. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in the company’s Annual Report on Form 10-K for the year ended Decemand the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (No Duty to Update The company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise. Risks and uncertainties include but are not limited to, general industry conditions and competition general economic factors, including interest rate and currency exchange rate fluctuations the impact of the global outbreak of novel coronavirus disease (COVID-19) the impact of pharmaceutical industry regulation and health care legislation in the United States and internationally global trends toward health care cost containment technological advances, new products and patents attained by competitors challenges inherent in new product development, including obtaining regulatory approval the company’s ability to accurately predict future market conditions manufacturing difficulties or delays financial instability of international economies and sovereign risk dependence on the effectiveness of the company’s patents and other protections for innovative products and the exposure to litigation, including patent litigation, and/or regulatory actions. If underlying assumptions prove inaccurate or risks or uncertainties materialize, actual results may differ materially from those set forth in the forward-looking statements. There can be no guarantees with respect to pipeline candidates that the candidates will receive the necessary regulatory approvals or that they will prove to be commercially successful. These statements are based upon the current beliefs and expectations of the company’s management and are subject to significant risks and uncertainties. Private Securities Litigation Reform Act of 1995. This website of Merck & Co., Inc., Rahway, N.J., USA (the “company”) includes “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. ![]()
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