Purpose:  The optimal chemotherapy regimen administered concurrently with preoperative radiation therapy (RT) for patients with rectal cancer is unknown. National Surgical Adjuvant Breast and Bowel Project trial R-04 compared four chemotherapy regimens administered concomitantly with RT.

The pilot project is an initial small-scale implementation that is used to prove the viability of a project idea. This could involve either the exploration of a novel new approach or idea or the application of a standard approach recommended by outside parties but which is new to the organisation. An example of this would be the standard implementation approach for a new off-the-shelf package.


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The trial forms part of a committed project and is intended to manage the risk of implementation roll out. It tests the implementation approach and its purpose is to manage the risk of implementation.

With a pilot study there is generally a high degree of uncertainty and there needs to be recognition on the part of both the project team and the governing stakeholders that the purpose of the pilot stage is primarily to prove viability, not deliver an agreed outcome.

There is a clear need for a control structure that enables prompt cancellation but also allows for the potential for radical changes in scope and direction if required. The intention is to create a controllable budget for people and supplies that will enable the project team to confirm that the underlying idea is sound.

The pilot study will confirm viability and scalability and enable proposed processes and procedures to be tested. It will confirm the appropriateness and safety of any tools proposed and also confirms that any working practices are safe and comply with organisational/statutory standards. It also enables the benefits to be tested and a more reliable investment appraisal to be created for the main project.

It enables the project team to test logistics, communications, stakeholder management plans and the effectiveness of any rollout tools. It can also enable deficiencies in project team briefing, training and skills to be ironed out before the main rollout begins.

There is a clear need for a control structure that enables prompt cancellation but also allows for the potential for changes in approach, scope and direction if required. The intention is to create a controllable budget for people and supplies that will enable the project team to confirm that the underlying plan for rollout is sound.

The trial enables a more accurate budget and plan to be produced for the main roll out and as with the pilot stage offers an opportunity for the benefits to be revisited in the light of practical rollout experience.

A trial does have some down sides, care needs to be taken to ensure that scalability is proven during the process and prolonged running with only the trial group can put business as usual activities under a great deal of strain.

If the SRO is more accustomed to holding project managers to account for delivery than being actively involved in the project process there may be a need for the project manager to spend more time with them outside of the formal sessions. To get the most out of pilot and trial activities the SRO really needs to be very close to detail of what is going on.

It may be that adopting a formal behavioural model such as SCARF - Status, Certainty, Autonomy, Relatedness, and Fairness - will help in drawing the SRO and project team closer together. Given the critical importance of the SROs active involvement in the process, time spent at the beginning of the process addressing any engagement issues will be time well spent.

As with all project activities, lessons learned and risks should be captured on an on-going basis and fed into the decision making process. The governance approach needs to be lesson and risk centric and offer the opportunity to respond flexibly and quickly to new discoveries.

The APM Body of Knowledge 7th edition is a foundational resource providing the concepts, functions and activities that make up professional project management. It reflects the developing profession, recognising project-based working at all levels, and across all sectors for influencers, decision makers, project professionals and their teams.

This notice of funding opportunity announcement (NOFO) is issued by the National Institute of Neurological Disorders and Stroke to enable submission of program project grant applications that propose conducting innovative, interactive research to answer significant scientific questions that are important for the mission of NINDS, via a synergistic collaboration between outstanding scientists who might not otherwise collaborate. The program project grant is designed to support research in which the funding of several interdependent highly meritorious projects as a group offers significant scientific advantages over support of these same projects as individual research grants.

The National Institute of Neurological Disorders and Stroke's program project grants (PPG) support investigator-initiated research programs, consisting of three or more highly interdependent projects, in which a team of investigators works in a clearly defined area of mutual scientific interest. In a program project, there should be a unifying, well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic and collaborative research environment that allows each research project to share the creative strengths of the others. Programs should present a compelling case in support of interrelated projects and collaborating investigators will yield results beyond those achievable if each project were pursued separately and without formal interaction among the participating investigators. The applicants should consider why the program project is required to achieve the proposed research goals, how reaching these goals may transform the field, and why the goals of the component projects cannot be achieved without significant contributions from the other components. Overall, the applicants should demonstrate a clear and compelling case that the component projects require one another and the shared core facilities.

In keeping with its tradition of strong support of investigator-initiated research, the NINDS expects the PPG director to define the integrating theme and to develop the approaches that would be used to accomplish the objectives of the proposed research program. The theme of a program project could be, for example, basic research on regeneration and plasticity in the nervous system or basic and clinical research on a specific disease process; the unifying concept could be a hypothesis concerning the fundamental mechanisms that result in the clinical manifestations of the specific disease process.

Clinical trials of new interventions in patients are NOT appropriate for inclusion in a program project grant. Investigators who wish to conduct such trials should consult with the NINDS Office of Clinical Research ( _research/index.htm.). Additionally, investigators are strongly encouraged to contact NINDS Scientific/Research staff if they want to propose a PPG in a subject area that is already represented by existing multi-component Center or grant programs (e.g., P50 or U54 activity codes).

Every component to be included in a PPG should be carefully considered. All projects that are included should be of the highest scientific and technical merit. All cores should provide resources that are essential to success of the goals and synergistic nature of the PPG. The PPG director must be an established leader in scientific research with demonstrated capabilities in program direction. Regular meetings of participating investigators who share and evaluate results and new ideas are essential to the consolidation of the research projects into a cohesive program.

There should be a clearly defined overarching goal or targeted area of research to which each component relates and makes essential contributions. It is expected that support of this set of interrelated projects and collaborating investigators will yield results that would not be achievable if each project were pursued separately and without formal interaction and/or collaboration among the participating investigators.

A PPG must contain a minimum of three component research projects. Each project should have significant and substantial scientific merit on its own as well as being an essential contributor to the central theme of the PPG. It should be evident that the synergistic and/or collaborative nature of the projects will help transform the field.

Program projects are expected to involve the participation of investigators in several disciplines (e.g., basic, translational, or clinical research) or investigators with special expertise in several areas of one discipline. All investigators should contribute to, and share in, the responsibilities of fulfilling the objectives of the PPG.

NINDS will only support applications to this NOFO that propose human mechanistic trials/studies that meet NIH's definition of a clinical trial. A mechanistic study is designed to understand a biological or behavioral process, the pathophysiology of a disease, or the mechanism of action of an intervention.

Such designs should be submitted to an NINDS clinical trial-specific funding announcement (listed on the NINDS website at -Research/Research-Funded-NINDS/Clinical-Research). Applicants are strongly advised to consult with NINDS Scientific/Research staff prior to submitting an application with human subjects to determine the appropriate funding opportunity.

The Impact score of the overall PPG application will be evaluated by considering the scientific merit and inter-dependence of the projects, the quality of supporting cores, and the administrative structure of the overall program because, in a program project, there should be a unifying, well-defined goal or targeted area of research to which each project relates and contributes, thereby producing a synergistic research environment that allows each research project to share the creative strengths of the others. The application should demonstrate that support of interrelated projects and collaborating investigators will yield results beyond those achievable if each project were pursued separately and without formal interaction among the participating investigators. Reviewers will evaluate the strength of the information provided in the application that a program project is required to achieve the proposed research goals, i.e. why the goals of the component projects cannot be achieved without significant contributions from the other components and how the component projects require one another and the shared core facilities. Specific factors that will be evaluated in the consideration of the overall program project include: 0852c4b9a8

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