Crossover Trials Sample Clauses

Crossover Trials. As an alternative to the standard parallel or independent designs for clinical trials, the crossover study design has some unique characteristics that make it beneficial to clinical disciplines as well as the pharmaceutical industry. In crossover designs, each treatment is administered to every study subject at different times using a randomly assigned sequence. Each subject thus receives all treatments, and therefore can serve as his or her own control. Xxxx in 1993 defined the crossover design, as a design “in which subjects are given sequences of treatments with the object of studying differences between individual treatments (or sub-sequences of treatments)”. (Xxxx, 1993). Crossover designs have been found especially common in neurology and psychiatry research, as well as of trials of pain treatment. (Xxxxxx & Blettner, 2012). In addition, researchers propose that crossover trials are appropriate in chronic stable disease research due to the unique design features. (Xxxx & Xxxx, 2004). In that case, the objective of a crossover trial should be to potentially alleviate symptoms, rather than treating the cause of the disease. (Xxxx & Xxxx, 2004). One primary advantage of the crossover trial design is that precision can be increased resulting from reducing the variance of the estimated difference in treatments. (Piatadosi, 1997; Xxxxx, 1999). Since each patient is his/her own control, problems with between-patient variation and some confounding factors (e.g. age, sex, and ethnicity) can be eliminated. Also, a crossover trial needs fewer patients compared to independent group designs because each study subject will receive all treatments – this may also improve patient recruitment and compliance. (Piatadosi, 1997). In addition, a much smaller sample size is needed to reach the same statistical power to test for treatment difference compared to a conventional parallel design, hence the designs are much more cost-effective. (Xxxxx, 1999). However, this type of design also has some potential disadvantages. A treatment administered in one period may have the possibility of influencing the patient’s response in the following period. The effects of a previous treatment being carried over to the next treatment period are called carry-over effects. In order to rule out the remaining effects from a completed treatment, a washout phase must be placed between the two treatment periods and it has to last long enough to ensure that patient’s response or disease status ...
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Related to Crossover Trials

  • Clinical Trials The studies, tests and preclinical and clinical trials conducted by or on behalf of, or sponsored by, the Company, or in which the Company has participated, that are described in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, or the results of which are referred to in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus, were and, if still pending, are being conducted in all material respects in accordance with protocols, procedures and controls pursuant to, where applicable, accepted professional and scientific standards for products or product candidates comparable to those being developed by the Company and all applicable statutes, rules and regulations of the FDA, the EMEA, Health Canada and other comparable drug and medical device (including diagnostic product) regulatory agencies outside of the United States to which they are subject; the descriptions of the results of such studies, tests and trials contained in the Registration Statement, the Time of Sale Disclosure Package or the Prospectus do not contain any misstatement of a material fact or omit a material fact necessary to make such statements not misleading; the Company has no knowledge of any studies, tests or trials not described in the Disclosure Package and the Prospectus the results of which reasonably call into question in any material respect the results of the studies, tests and trials described in the Registration Statement, the Time of Sale Disclosure Package or Prospectus; and the Company has not received any notices or other correspondence from the FDA, EMEA, Health Canada or any other foreign, state or local governmental body exercising comparable authority or any Institutional Review Board or comparable authority requiring or threatening the termination, suspension or material modification of any studies, tests or preclinical or clinical trials conducted by or on behalf of, or sponsored by, the Company or in which the Company has participated, and, to the Company’s knowledge, there are no reasonable grounds for the same. Except as disclosed in the Registration Statement, the Time of Sale Disclosure Package and the Prospectus, there has not been any violation of law or regulation by the Company in its respective product development efforts, submissions or reports to any regulatory authority that could reasonably be expected to require investigation, corrective action or enforcement action.

  • Treatment Program Testing The Employer may request or require an employee to undergo drug and alcohol testing if the employee has been referred by the employer for chemical dependency treatment or evaluation or is participating in a chemical dependency treatment program under an employee benefit plan, in which case the employee may be requested or required to undergo drug or alcohol testing without prior notice during the evaluation or treatment period and for a period of up to two years following completion of any prescribed chemical dependency treatment program.

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  • Screening 3.13.1 Refuse containers located outside the building shall be fully screened from adjacent properties and from streets by means of opaque fencing or masonry walls with suitable landscaping.

  • Study An application for leave of absence for professional study must be supported by a written statement indicating what study or research is to be undertaken, or, if applicable, what subjects are to be studied and at what institutions.

  • System Impact Study An assessment by the Transmission Provider of (i) the adequacy of the Transmission System to accommodate a Completed Application, an Interconnection Request or an Upgrade Request, (ii) whether any additional costs may be incurred in order to provide such transmission service or to accommodate an Interconnection Request, and (iii) with respect to an Interconnection Request, an estimated date that an Interconnection Customer’s Customer Facility can be interconnected with the Transmission System and an estimate of the Interconnection Customer’s cost responsibility for the interconnection; and (iv) with respect to an Upgrade Request, the estimated cost of the requested system upgrades or expansion, or of the cost of the system upgrades or expansion, necessary to provide the requested incremental rights.

  • Library CONTRACTOR shall provide an inmate law library in compliance with Rule 33-501.301, F.A.C., FDC’s Policy 501.301, and ACA Standards.

  • Diagnostic procedures to aid the Provider in determining required dental treatment.

  • Vaccination and Inoculation (a) The Employer agrees to take all reasonable precautions, including in-service seminars, to limit the spread of infectious diseases among employees.

  • Commercialization Intrexon shall have the right to develop and Commercialize the Reverted Products itself or with one or more Third Parties, and shall have the right, without obligation to Fibrocell, to take any such actions in connection with such activities as Intrexon (or its designee), at its discretion, deems appropriate.

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