Clinical trial proposal
Department of health & human al institutes of are herehome » research » clinical t proposal for nidcd clinical current national institutes of health (nih) definition of a clinical trial is:"a research study in which one or more human subjects are prospectively assigned to one or more interventions (which may include placebo or other control) to evaluate the effects of those interventions on health-related biomedical or behavioral outcomes.
Details, see the nih office of extramural research's topics below are intended to guide the process and organization for a clinical trial plan.
State the public health need that is addressed and the trial's potential impact on clinical care and patients' the primary study objective and any secondary study objectives.
Later phase studies tend to have as objectives to establish—on the basis of a prospective analytic plan—efficacy and benefit-to-risk of an intervention with as much objectivity and precision as the proposed clinical trial is part of a larger development program, describe how the proposed study relates to the overall programmatic activities and applying for funding through a u01 or u34 mechanism, check that preliminary data are adequate and persuasive to meeting funding prior clinical trial experience is minimal or in another domain, appoint clinical trial expert(s) with experience with the proposed type of study as key personnel to help with study design and t a biostatistician—preferably with relevant clinical trial experience—as one of the key single site studies, identify a data repository and analytic team, study monitors, and qualified personnel for data collection, interaction, and communication with multisite studies, identify a data coordinating center and an independent data monitoring committee if warranted.
For additional guidance, see nidcd guidelines for data and safety monitoring of clinical applicable, describe an interim monitoring plan, including the schedule of interim analyses and guidelines for stopping the study for reasons of safety, futility, or reaching a predetermined efficacy y describe the study design and indicate, in general terms, how the design will fulfill the objectives of the study.
For an early phase clinical trial, describe how the results will be used to support later phase clinical the proposal is for a later phase trial to formally establish efficacy, state clearly if the objective is to demonstrate superiority of an intervention and establish a new standard of care, or if the objective is to demonstrate non-inferiority and establish an acceptable alternative to current treatment specific inclusion and exclusion criteria.
Describe the methods for identifying and recruiting be the number of volunteers to be enrolled and the statistical and clinical basis for the sample size te the number of clinical sites needed to meet target enrollment in the projected time frame and the basis for the be the extent and type of blinding or masking to reduce bias.
When possible, mask the individuals measuring the primary be the randomization be how the intervention will be administered, including dose and duration as be the quality assurance and record keeping procedures to be used to ensure that each volunteer receives the correct treatment at the intended terize each outcome measure, particularly the primary outcome measure, with regard to clinical relevance (for example, improves communication and general function or alters the natural history of the underlying condition), validity in the target population, precision, and sensitivity.
For early phase studies, specify an efficacy threshold needed to progress to a later phase clinical ic the statistical methods to be used to analyze the study outcomes and the rationale for their selection.
Note whether the interpretation of the results is dependent upon rejection of the null hypothesis and to what level of precision—on the calculation of confidence intervals, on a difference in event counts, or on other n how bias and uncertainty will be approached and minimized, and any potential adjustments to the data to n how missing data, outliers, noncompliance, and losses to follow-up will be handled in the entation te trial duration.
Develop a plan in case accrual is lower than expected such as considering adding locations, adjusting eligibility criteria, or rescoping study te trial cost.
For multi-site studies, budget for a clinical coordinating center, data coordinating center, and data monitoring committee, as an fda regulated product that may require an investigational new drug (ind) application or an investigational device exemption (ide), try to obtain the ind, ide, or written exemption from the fda before submitting the funding any participating pharmaceutical or device manufacturing be how data will be collected, handled, and stored.
Some clinical trials may require an independent data coordinating te if any member of the clinical trial study team, including the investigators, has a financial conflict of interest or holds a patent for the use of the intervention in the late phase trials, consider collaborating with an nidcd clinical research network such as te direct costs for all years of funding.
Notify the program officer 30 days before submission if you are requesting $500,000 or more in direct costs in any a planned submission date for funding based on the programmatic more information, contact your nidcd program sted in a comprehensive proposal, ballpark pricing, or strategic review of your protocol or clinical development plan?
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It should stand on its own, and not refer the reader to points in the project ol title, protocol identifying number (if any), and and address of the sponsor/ and title of the investigator(s) who is (are) responsible for conducting the research, and the address and telephone number(s) of the research site(s), including responsibilities of (s) and address(es) of the clinical laboratory(ies) and other medical and/or technical department(s) and/or institutions involved in the ale & background rationale specifies the reasons for conducting the research in light of current knowledge.
It is the equivalent to the introduction in a research paper and it puts the proposal in context.
Can also be listed at the end of part goals and are broad statements of what the proposal hopes to accomplish.
Must also be the case of a randomized controlled trial additional information on the process of randomization and blinding, description of stopping rules for individuals, for part of the study or entire study, the procedures and conditions for breaking the codes etc.
For projects involving qualitative approaches, specify in sufficient detail how the data will be protocol should describe the quality control and quality assurance system for the conduct of the study, including gcp, follow up by clinical monitors, dsmb, data management ed outcomes of the protocol should indicate how the study will contribute to advancement of knowledge, how the results will be utilized, not only in publications but also how they will likely affect health care, health systems, or health ination of results and publication protocol should specify not only dissemination of results in the scientific media, but also to the community and/ or the participants, and consider dissemination to the policy makers where relevant.
