Clinical research proposal

2); 2008 s:article | pubreader | epub (beta) | pdf (139k) | tees and ch policy ended format for a research the abstract of a research paper, the project summary, should be no more than 300 words and at the most a page long (font size 12, single spacing). 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. It should answer the question of why and what: why the research needs to be done and what will be its relevance. Can also be listed at the end of part goals and are broad statements of what the proposal hopes to accomplish. They create a setting for the ic objectives are statements of the research question(s). Objectives should be simple (not complex), specific (not vague), and stated in advance (not after the research is done). The design of the study should include information on the type of study, the research population or the sampling frame, and who can take part (e. For example, a study may be described as being a basic science research, epidemiologic or social science research, it may also be described as observational or interventional; if observational, it may be either descriptive or analytic, if analytic it could either be cross-sectional or longitudinal etc.

The link below provides more information on how to describe a research methodology section is the most important part of the protocol. Interventions could also be in the realm of social sciences for example providing training or information to groups of ures could be biomedical (collection of blood or sputum samples to develop a diagnostic test), or in the realm of social sciences (doing a questionnaire survey, carrying out a focus group discussion as part of formative research, observation of the participant's environment, etc. Safety aspects of the research should always be kept in mind and information provided in the protocol on how the safety of research participants will be ensured. It is useful to remember that even administering a research questionnaire can have adverse effects on research protocol must give a clear indication of what follow up will be provided to the research participants and for how long. This may include a follow u, especially for adverse events, even after data collection for the research study is management and statistical protocol should provide information on how the data will be managed, including data handling and coding for computer analysis, monitoring and verification. 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. It should also describe how the investigator(s) plan to obtain informed consent from the research participants (the informed consent process). If the research involves more than one group of individuals, for example healthcare users and healthcare providers, a separate specifically tailored informed consent form must be included for each group. For guidance on how to write an informed consent form, click mmes and region of the south-east asia eastern mediterranean western pacific up for who sted in a comprehensive proposal, ballpark pricing, or strategic review of your protocol or clinical development plan?

Trials can do for you are a pharmaceutical, biopharmaceutical or medical device company and are interested in worldwide clinical trial’s contract research or bioanalytical lab services please let us know how we can help by filling out the form : if you’re a healthy volunteer interested in participating in a clinical trial click form has been successfully submitted! Asa members ation of the investigator for a research ts into the reviewer's l articles  |   june 1998writing successful research proposals for medical  a. Shafer) staff anesthesiologist, palo alto va health care system; associate professor of anesthesia, stanford g successful research proposals for medical esiology 6 1998, vol. Doi:High-quality research proposals are required to obtain funds for the basic and clinical sciences. In this era of diminishing revenues, the ability to compete successfully for peer-reviewed research money is essential to create and maintain scientific programs. Ideally, the essentials of “grantsmanship” are learned through observation and participation in grant preparation, but the training environment experienced by most physicians typically focuses on clinical skills. Most physicians are never exposed to a research environment and therefore do not learn how to write grants. The result is that many clinical studies, even when designed by skilled clinicians and those that address important clinical questions, often do not compete successfully with proposals written by basic scientists. This creates a perception that clinical studies are not favorably viewed by research review committees.

The opposite is probably closer to the truth; research review committees are very keen to fund excellent clinical research. Degrees have applied for national institutes of health (nih) grants compared with researchers with m. In 1993, it is apparent that resubmission of a revised application significantly increases the overall chance of having research proposal ultimately funded. Research questions posed must be hypothesis driven; the investigator must be qualified to perform the study; and preliminary evidence should be presented demonstrating that the research is feasible and will answer the questions posed. The goal of this article is to review important elements of successful research proposals, with emphasis on funding sources available to the anesthesiology community. Two important anesthesia-specific organizations exist to support anesthesia research - the foundation for anesthesia education and research (faer, an organization under the auspices of the american society of anesthesiologists) and the international anesthesiology research society (iars). Applications for research support from faer and iars have many of the characteristics of grants funded by the nih and other peer-reviewed funding sources. These characteristics include (1) a highly qualified investigator(s);(2) for junior investigators, a mentor with a successful track record in scientific investigation, peer-reviewed funding, and mentorship of fellows and faculty;(3) a supportive academic environment; and (4) a scientifically sound proposal. Each of these characteristics is discussed in the subsequent ation of the investigator for a ng of the of the most important components of a successful research proposal is a well-trained investigator.

Training in clinical anesthesia is not training in research methodology or scientific thinking; it does not prepare an individual for a career in investigation. Although obvious for basic science research, clinical research also requires commitment of a minimum of 1 yr of dedicated training with a good mentor, and more typically 2 - 3 yr in the field of the proposed research. Research proposals must document institutional support for nonclinical time, and the investigator must provide evidence that this time has been used wisely and will continue to be dedicated to the proposed research proposal must document a track record of productivity by the investigator. Fellowship awards do not have an expectation of prior research training, so publications from prior research are not expected. Young investigator annoucements (from faer) and several new iars awards require several years as a successful junior faculty member, so expectations of demonstrated research success are further increased. The investigator must demonstrate (1) rigorous training, (2) commitment to research, (3) an appropriate career path, and (4) a track record of productive work. None of these are trivial issues, and none can be easily accomplished without making a commitment to research early in the academic quality of the mentor is another important aspect of awards granted to fellows and junior faculty. Criteria for this include a track record of publication in the area of the proposed research, continued peer-reviewed funding, and a history of successfully training young investigators. In addition to the mentor, high-quality coinvestigators, collaborators, and consultants also play important roles in strengthening a research research is best accomplished in a supportive, cooperative environment.

Because of the changing climate of clinical medicine, researchers (both clinical and basic science) face increasing pressure to minimize research time. Documentation of adequate nonclinical time for research (not for committee meetings or other unrelated tasks) is essential. Receiving funding at a junior level often enables the department to match funds or to guarantee nonclinical time to the budding investigator. In general, the more non-clinical time available to an investigator, the more competitive the important elements of the environment include people, space, and institutional resources. People include mentors, consultants who can help with specific methodologies, statistical support, helpful colleagues, experienced technicians, a clinical research team, and a dedicated chairperson. There must be adequate space for performing the proposed studies, office space for research personnel, and storage space for equipment and supplies. Institutional resources include related departmental and interdepartmental seminar series, a critical mass of investigators in a related area, instrument development and repair shops, and necessary laboratory space and common research ia for a sound research proposal are the same whether the proposal is submitted to nih, faer, iars, or other funding sources. In crafting a proposal, it is essential to consider the perspective of the reviewer; therefore, items of interest to the reviewer are listed after general definition of the grant committees receive dozens of grants. Hence, the abstract is often one of the most important parts of the research proposal.

It is here that the investigator crystallizes the overall goal of the research and states specific ing with the specific aims, the proposal must be well written and logically organized. Organization of the specific aims is often temporal, starting with a proposed mechanism or the first set of studies in a clinical project. The background section provides an opportunity to bring reviewers up to date on current research in the area of the proposal. The most crucial aspect of the background is to build a case for significance of the proposed research regarding the ultimate clinical application or mechanistic understanding. Ideally, the background section should demonstrate that the current proposal is a logical extension of previous studies in the field and will provide new information and novel insights. Preliminary data provide the opportunity for the investigator to demonstrate his or her ability to perform the proposed research. In clinical studies, demonstration of a working investigative team and the ability to enroll a given number of patients per week is helpful. Common errors in design include lack of specification of primary outcome, lack of randomization or blinding in clinical trials, inadequate justification of sample size, failure to adjust the total study number for expected dropouts/failed experiments or patient refusal, and use of single drug doses or concentrations rather than development of dose - response or concentration - response relations. Common errors in conducting research include lack of confirmation of drug concentrations, inadequate reproducibility of final results, lack of standardization of procedures, inadequate follow-up, incomplete data recording, and overall lack of uate or inappropriate statistical methods can be a major weakness of a grant proposal.

Because statistical issues underlie the design and analysis strategy for every study, the input of a biostatistician is essential in planning the research and writing the grant application. Common statistical errors in research proposals include lack of sample size/power calculations, treating continuous variables as dichotomous, repeated t tests when a more comprehensive modeling approach should be taken, application of statistical tests that assume normality without verifying assumptions, failure to consider covariate effects, and failure to distinguish between interindividual and intraindividual variability. At least one full paragraph (and sometimes an entire page) of the research proposal should be devoted to statistical analysis. Reviewers tend to be impressed when the investigator presents potential problems that never occurred to them, because it suggests that the investigator is an expert in this area of research. When submitting a revised application, an introduction (placed before the specific aims section) is used to discuss how criticisms of the original grant have been addressed in the revised proposal. Because the reviewer's comments are intended to be helpful, it is important to address each concern carefully in the revised proposal (changed text should be highlighted in the revised application by italic, bold, or identifying lines in the margin), with changes outlined in the introduction section. Into the reviewer's writing a research grant, it is helpful to consider the reviewer's perspective. The nih recently has published two documents on-line that discuss review criteria; examination of these documents before submission of a research proposal may prove helpful. These include the report of the committee on rating grant applications[double vertical bar] and review criteria for rating unsolicited research grants.

The litmus test for clinical significance is whether the proposed research will improve patient care. The ideal research question succeeds in being significant in both reviewer assesses whether the research plan can support or refute the stated hypothesis. To ensure that the nonexpert is convinced of the validity and importance of proposed methodologies, the overall proposal should be written with a logical flow of ideas that build from basic to sophisticated concepts. For example, a power analysis and corresponding data on the number of patients with the required characteristics at the investigator's institution helps convince reviewers that a clinical study is esiology funding g for research performed by anesthesiologists is available from many sources. Because the discipline of anesthesiology overlaps many other fields, anesthesiologists have the opportunity to apply for research funds from agencies as diverse as the american academy of pediatrics, american cancer society, american heart association (national and local), american thoracic society, american society for regional anesthesiology, critical care societies, department of veterans affairs, national science foundation, shriners, society for cardiovascular anesthesiology, society for obstetrics and perinatology, national aeronautics and space aviation, nih, and many other private foundations. For fiscal year 1996, the nih awarded 149 research grants (including career development grants, r29, r01, and program project grants) to departments of anesthesiology, totaling $21 million in direct costs ([almost equal to]$31 million in total costs). Because of the diversity of research projects in anesthesiology, these grants were awarded by 14 different institutes, centers, and divisions within the nih. Unique to faer and iars research committees is that the reviewers are mostly investigators and practicing anesthesiologists. These reviewers fully appreciate the importance of clinical research and enthusiastically support high-quality clinical studies.

Although descriptive clinical studies are interesting to practicing clinicians, from a scientific perspective, clinical research must be driven by testable hypotheses. Without a testable hypothesis, clinical research cannot pass the test of adequate significance required for is our hope that by demystifying the grant writing and review process that more anesthesiologists will be encouraged to submit proposals for research funding. As part of this effort, we strongly encourage residents and fellows interested in research careers to obtain adequate research training and to apply for appropriate fellowship/junior faculty awards early in their careers. Bethesda, office of reports and analysis (component of the office of extramural research), national institutes of health. We'll send you your username identified by your email proposal samples  analysis of a scientific or medical problem community service & leadership medical education scientific research focused clinical multidisciplinary smp1 - [71 kb] cs1 - [17 kb] cs2 - [19 kb] cs3 - [22 kb] meded1 meded2 sr1 - [23 kb] sr2 - [9032 kb] fcm1 - [ kb] fcm2 - [51 kb] you must have adobe acrobat reader to view or print these pdf files.