If anyone has taken Dr.Simon BME 682 class they know a little bit about Project management and in week 2 he discussed some aspects of PM. Where does PM fit into pre-clinical and/or clinical studies? Do we need planning (even though we its an obvious yes) to figure out how many animals we need to study? What tests need to be done? Do we have money in the budget to accommodate this study? Do we need a WBS to accomplish an effective study? Who are the important people that need to be contacted?
Like any other project, the Project Manager is fully involved in pre-clinical studies. PMs are involved in the preparation of the business case and need for the study, developing the schedule, budget, and coordinating the team through each stage (planning, executing, controlling, and closing). As a team, each subject matter expert (SME) will contribute in the development and approval of the study protocol, identifying the tests that will need to be done to receive the desired results for a specific claim, and will also conduct thorough literature research in what has been done in the past. The SMEs will also review any SOPs that are currently in place in the company and the PM will ensure that the SOPs are updated in respect to regulations and the intended research study. Important people that need to be contacted are the stakeholders (i.e. animals, technologists, scientists, veterinarians, facility managers and staff, etc.), funding bodies (i.e. NIH), ethical review boards, national committees, and regulatory authorities (pre-approval and guidance of the study). The PM with their project team will define strategies and identify alternative solutions when necessary. The PMs will manage the selection of full time employee (FTE) resources and outsourcing to contract research organizations (CROs), coordinate the study activities ensuring they are completed on time, be a part of reviewing validation documentation and results, and review the materials that will be submitted to obtain a regulatory claim or approval.
As mentioned in Dr.Simon's lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully. The Initiating Phase would consist of a lot of the literature searches and background knowledge compiled once a project has been decided on. In many cases there may have already been similar experiments conducted, so they can be used as templates which you input the parameters specific to your own project. The Planning Phase would probably consist of putting writing your research protocol. This would include the methods to complete the experiment along with all the materials you will need. A Gantt chart and budget breakdown would be created as they are crucial in organizing your project. Like any other project, after you start conducting it, you will have to monitor it as well and be ready to intervene if problems arise. These may be labs which are miles and miles away from you, so you must be willing to commit more resources to be able to travel to different sites. The Closing Phase will also be standard in that you summarize the protocol results and end all contracts which were signed in the beginning of the experiment. Clearly, these basic project management techniques can be applied to a wide variety of projects, from anything like constructing buildings to testing drugs on mice.
As mentioned in Dr.Simon's lecture on managing a research project, there are several key steps to follow if you are going to complete it successfully. The Initiating Phase would consist of a lot of the literature searches and background knowledge compiled once a project has been decided on. In many cases there may have already been similar experiments conducted, so they can be used as templates which you input the parameters specific to your own project. The Planning Phase would probably consist of putting writing your research protocol. This would include the methods to complete the experiment along with all the materials you will need. A Gantt chart and budget breakdown would be created as they are crucial in organizing your project. Like any other project, after you start conducting it, you will have to monitor it as well and be ready to intervene if problems arise. These may be labs which are miles and miles away from you, so you must be willing to commit more resources to be able to travel to different sites. The Closing Phase will also be standard in that you summarize the protocol results and end all contracts which were signed in the beginning of the experiment. Clearly, these basic project management techniques can be applied to a wide variety of projects.
Based on the pre-clinical research lecture, the project manager is most important for setting a protocol for the project and going through the steps of getting the project approved, but they may not be as involved when the study is actually being done.
The first step of the study would be to get the project idea from the boss and get a general idea for the project based on current models in the field. Next the PM finds a local, and does sufficient research to plan out and write a protocol. Then, the various parts of the protocol (budget, timeline, reports, etc.) must be approved before a contract can be written. In order for the study to be done next, the contract must be approved and signed by the legal department, management, and the testing lab. During the study, the PM basically just visits the study sites and begins to tabulate results. At completion of the study, the PM must approve the reports from the testing lab and make meaning of the results to present to management.
The project management body of knowledge provides the fundamental information to form a foundation for projects of all sizes, however it is not pertinent to apply the entirety of the body of knowledge to every project. I believe it is important for team leaders and members to have a basic understanding of the project management body of knowledge and use it as a rough guide for their projects. By understanding the five process groups and ten knowledge areas, a team should be able to grasp the big picture of their project and organize it using basic tools and techniques in order to properly manage the project. All of the questions presented are answered when following the five process groups and ten knowledge areas of project management. Pre-clinical and clinical studies are nothing more than projects, therefore the project management body of knowledge can and should be applied to some degree.
If anyone has taken Dr.Simon BME 682 class they know a little bit about Project management and in week 2 he discussed some aspects of PM. Where does PM fit into pre-clinical and/or clinical studies? Do we need planning (even though we its an obvious yes) to figure out how many animals we need to study? What tests need to be done? Do we have money in the budget to accommodate this study? Do we need a WBS to accomplish an effective study? Who are the important people that need to be contacted?
Project management is always a useful tool in any type of research but for pre-clinical and clinical trials PM is extremely vital. As you mentioned the planning portion of PM for any clinical study is obviously the foundation for a successful product and it is the part of the PM process where a team can map out their methods and procedures, safety protocols, time management rules and their budget. I also think the questions you mentioned in your post are some important things to think about in a PM group for a clinical study and they would most likely be answered during the planning portion of the project which just another reason why that aspect is the most important part of the PM process.
Project management takes place in every step of the preclinical research from setting the deadline, budget, and schedule to choosing the team that will work on the project. As you mentioned it is an obvious yes, planning is an essential step in the preclinical research and to avoid cutting corners, having a successful intention step and planning step will allow the team members to set an effective WBS in terms of the duration and budget of each task. Even though in every step of the project we believe in the quote "Devil lies in the details," having a well-developed WBS will help the team predict the obstacles and come with prevention solutions to avoid cutting corners in the plan which could cause the study to be worthless and ineffective.
Considering the fact that a pre-clinical study and/or clinical study consist of several tasks, this would constitute a project, so a project manager would be necessary in this case. The project manager is tying all the personnel that are involved with this study together so that they work together, being open to the research and the next steps. The FDA provides several documents of guidance on the animals needed for the studies, which helps narrow the animal selection for the study. The primary responsibility of the project manager is to keep on schedule with the project milestones, such as deliverables for the study. Testing that needs to be done would be done by the researchers, determining the appropriate tests, but the manager would be made aware of the timeline of those tests and adjust his timeline to accommodate these tests. A project manager would use a WBS as one of the tools to keep all the study parts together and show how each part connects. Another useful tool would be to make a Microsoft Project to keep everything organized. By keeping everything on schedule with the milestones, a project manager would be necessary for a study.
Pre-clinical research cannot and will not be successful without effective Project Management. Every aspect of the project management life cycle is used in effective pre-clinical studies. During the Initiation Phase, researchers receive the project and need to thoroughly look through academic literature to compile background information for the project. From this literature review, they'll gain essential information such as how similar protocols were designed, safety concerns, issues other researchers ran into, etc. During the planning phase, researchers will take the information they obtained from the initiation phase and use that information to create an in-depth, well-informed protocol for the study. Without a finely tuned and well-thought-out protocol. the pre-clinical research will not meet its ultimate goal of showing both the efficacy and safety of a medical device. During the execution phase, researchers will follow the protocol that they designed. At the same time, they will be monitoring and controlling their study, overcoming any unexpected challenges that arise, and ensuring that the protocol is being followed without any deviations. Finally, the project "closing" involves analyzing/interpreting the data as well as writing articles that explain the results of the study. Project management is essential to success in pre-clinical research. If any of the aforementioned steps are not performed, the project will fail.
When managing research in Industry, there is a “how to” guide for basic Research Scientists in Industry: Step 1: Your boss tells you to do a study. You may not know much about the subject, Do a literature search, Get general idea for the field, Find a research model and be able to defend it. Step 2: Find a place to do research, In house, in an Academic lab, or at a Contract lab. Step 3: Write a research protocol. Step 4: Agree on the protocol with the lab doing the study, what is its Budget, the Timing Allowed, what Reports conducted, GLP or non-GLP? Step 6: Place these items into a contract, allow lots of time for Legal Dept. to get to it, make appointments with lawyers so you can get in their faces. Step 7: Get contract approved and signed by Management and testing lab, Warning: Management is slow, Warning 2: Academic legal departments are slower. Step 8: Do the study! Step 9: Manage “in-life” phase of study, visit study site and tabulate the results. Step 10: Get a report on the study from the testing lab. Step 11: Present results to management, meaning, you may have to compile the results with other reports, other departments, etc. The Pitfalls could be not enough time, the study takes longer than management wants it to, prepare to cut corner. Delays are animals take time to come in when ordered, animal suppliers run out of animals, always have alternate supply, if possible, and have alternate models or be able to chop off time points. There may not be enough money. “You want how much for that model??” Study gets pared down until worthless, and Study gets canceled. Also, there may be a poor study design from beginning.
Project Management (PM) plays a vital role in both pre-clinical and clinical studies by providing structure, organization, and oversight to ensure that these complex and highly regulated processes are completed efficiently and effectively. PM helps structure and organize the entire study process, from the planning phase to the execution phase. For example, during pre-clinical studies, careful planning is essential to determine the number of animals required for statistically valid results, identify the necessary tests, and ensure ethical considerations are met. Furthermore, financial planning is another vital aspect in which the PM helps assess whether the study budget can accommodate all the required elements. This includes the staff, equipment, and regulatory compliance. As for a Work Breakdown Structure (WBS), these can be crucial to making a study effective because it divides the project into smaller, more manageable tasks that are easy to track progress for. This greatly benefits the PM by improving organization, efficiency, and control over the project, ensuring that it remains on track and within scope. PM also involves identifying key stakeholders, such as regulatory bodies, sponsors, and ethics committees, and maintaining clear communication with these individuals throughout the study. Without proper PM, studies could face delays, budget overruns, or regulatory issues, making it a cornerstone of any successful pre-clinical or clinical research. In conclusion, project management is absolutely vital to the success of pre-clinical and clinical studies, as they contribute to so many aspects of the studies.
