Research Project Management

Katie S. Gatwood, PharmD, BCOP
Stem Cell Transplant & Cellular Therapy Clinical Pharmacist Specialist
PGY-2 Oncology Residency Program Director
Vanderbilt University Medical Center
Nashville, TN

The residency research project is one of the biggest hurdles residents face on the road to graduation. It is typically the most significant longitudinal requirement of the residency program and the one that most residents feel the most inexperienced with and therefore, can be especially daunting. As a residency program director and a regular research project preceptor, I will use this column to provide some tips and tricks to address some of the most common research project pitfalls.

Pitfall #1: Project selection
The project selection process can be highly variable among residency programs. Some programs provide residents with a list of project ideas to choose from and others will ask the resident to identify their own project. The latter can be especially challenging, particularly for residents who did not early commit to their program as they are also learning workflows and adapting to a new institution and practice site. It can also be more challenging for residents who have more limited prior experiences in oncology. It is hard to identify areas in need of clinical investigation when you are a novice in the field.

If you are in the position of having to identify your own project idea, I encourage you to utilize your preceptors and mentors to aid you in this process. Even something as simple as discussing topics you are interested in or questions you have regarding certain practices can end up sparking an idea. Also remember that just because you are in an oncology program does not mean your topic has to be strictly oncology focused. Any project that is conducted within an oncology population can inherently be considered an oncology project. Additionally, given the rapidity of new drug approvals in the oncology space, there is ample opportunity to study the many unknowns regarding proper use of these medications. Drug interactions and use in special populations or circumstances that were not included in clinical trials can be excellent research project ideas and there is always a need for more “real-world” data in the published literature.

For those residents who are selecting a project from a provided list, I believe there are some good things to keep in mind or ask of the project preceptor to ensure the highest likelihood of project success. First, consider the data sources for the project and how data will be obtained. For instance, do these sources require separate approval outside the IRB to obtain data or will they require any degree of manual review of a list of patients to identify those who can be include in the final data set? If so, these could be sources of potential delays. Another key consideration for project feasibility is the extent of manual chart review that is required. This is typically the most common issue I see leading to project delays so getting a realistic grasp on this before you begin the project is critical in ensuring it is a feasible project for the one-year timeline. If you can find a project that uses pre-existing data sources, such as an internal patient registry, or that largely includes data points that are discrete variables which can easily be pulled from the electronic medical record, I highly encourage selecting those. Finally, it is also important to determine the statistical plan for analysis of the results. Depending on how advanced the statistics needed are, you may need to plan for obtaining the help of a statistician or further training for yourself to conduct the analysis. Overall, I recommend selecting a project that is feasible, meaningful to practice, and of interest to you – in that order. Most graduating residents tell me that having a completed project that is easily publishable is more important than working on a project that they found to be the most interesting.

Pitfall #2: Project delays
Some sort of delay is almost inevitable with any research project, including residency research. There is always the potential for unforeseen circumstances that impact the project timeline. Therefore, I have two main tips to try and limit these and their impact as much as possible. First and foremost, make sure you thoughtfully consider the questions that I addressed in the project selection section above. This can help you predict where delays could occur so you can either prevent them or proactively identify strategies to deal with them. I encourage you to play a game of “worst case scenario” with your project preceptor where you try to identify all barriers you could encounter with the project. We do this within the Residency Research Advisory Committee at our institution prior to a resident submitting their project to the IRB and it frequently leads to changes to the original data collection plan or even the project proposal to help prevent common sources of delays, such as IRB revisions.

My other major piece of advice for dealing with project delays is to manage your time wisely and effectively. There is a lot of “down time” with research projects where you are waiting for something needed to move on to the next step, such as waiting for IRB approval, waiting to obtain a data set, or waiting for results to be analyzed. The biggest mistake you can make is to do no work on the project during these periods. If you use these periods to make some sort of forward progress, you will have more time available to manage and offset any delays that are likely to occur. For example, while waiting for IRB approval, you can work on your creating data collection tool, such as an Excel spreadsheet or a Redcap database. While waiting for your data set, you can create a plan with your preceptor on how you can get statistical assistance with the project if you know the analysis is beyond your capabilities, which could include securing funding for a statistician or taking an online biostatistics course. Finally, while waiting on your project results, you can begin to work on your abstract for submission to present as a poster at a professional meeting as well as work on the background and methods sections of a poster and/or manuscript so there is less to do when the data analysis is completed. Effective time management is one of the biggest keys to ensuring successful project completion when dealing with such a tight timeline.

Pitfall #3: Incomplete or unexpected results
Despite best efforts, there are still circumstances where residents do not have complete project results in time for presentation at a professional meeting or even for residency graduation. Alternatively, you may have results, but they are unexpected and dramatically alter the course of the project. Both scenarios can be incredibly stressful and disheartening when you have put such a great deal of time and effort into a project. Fortunately, all is not lost and there are still several ways that you can recover and make the most of what results you have.

First, you can still make an effective and meaningful presentation without complete results. Even if you don’t have any statistical analyses performed, you can often present demographic and qualitative data from the project that are still insightful. These data can tell a story, such as providing an overall incidence of an endpoint or outcome, even if you aren’t able to compare it to a control or historical group or link it to risk factors, as you may have planned in the original project proposal. If you have unexpected results, remember that these are still worth presenting and/or publishing. Trials with negative or “insignificant” results are infrequently published as they are often viewed as unimportant but there has been a push within the oncology community to publish more of these studies as they still provide valuable knowledge to apply to practice.

Finally, if you and your preceptor deem that your project truly cannot be published or presented due to incomplete or unexpected results, consider whether other projects you have worked on during the residency year can be published instead. In our program, we have had several residents who published the results of their medication use evaluations instead of their research projects. Otherwise, if obtaining a publication is one of your goals you can also talk to your program director and preceptors about other opportunities for this, such as writing a review article.

I hope these tips will prove useful to all of you out there embarking on the exciting journey of residency research. Remember that proper planning and some creative thinking can go a very long way in ensuring the success of your project!