Resident’s Cubicle: Research Projects

Megan Bodge, PharmD
Stem Cell Transplant Clinical Specialist
VA Tennessee Valley Healthcare System
Nashville, TN

The residency year starts each July with a new crop of bright-eyed oncology pharmacy residents and a flurry of activity to prepare for the coming year. Residents often are expected to complete multiple projects throughout their 1-year residency—from medication usage evaluations to administrative projects to their main research project. They usually are expected to hit the ground running with early project selection and institutional review board (IRB) submission, all while getting acclimated to new practitioners, computer systems, and institutional practices. This edition of The Resident’s Cubicle will focus on tips to help residents with their post-graduate year 2 (PGY-2) research projects.

Residents entering their PGY-2 should be comfortable completing various projects given experiences from their first year of residency; however, they should be ready for the increased expectations and demands of PGY-2. Projects completed in the first year may not have been oncology focused and may have been the resident’s first experience with completing a major research project. With the transition to PGY-2, residents should be prepared to complete a high-quality project, which may require broadening their oncology knowledge base. Preceptors may also expect that the project will be completed with more independence and at a higher level than was expected during the previous year. Residents should be prepared to undertake a project that holds potential benefits for their own learning, their institution, and, ideally, oncology pharmacy practice. Although this may seem overwhelming at the beginning of the year, breaking the project down into smaller steps that can be accomplished throughout the year can make it more manageable.

Project Selection

Most residents will be presented with a list of possible project ideas at the beginning of their PGY-2—a result of preceptor brainstorming during the prior year. The number and type of team members (physicians, pathologists, nurses, etc.) involved with the project will vary based on the complexity of the project and subject matter. It is important that all of the key practitioners are involved; having a large research team can be helpful when brainstorming ideas and delegating project tasks. However, a large team also can be challenging because it is difficult to please everyone when ideas differ among team members. An additional challenge for incoming residents at a different institution than in their first year is getting a good feel for the preceptors and practitioners with whom they will be working on each project. Prior residency alumni are a great resource and often are willing to give candid advice about strengths and weaknesses of specific projects or preceptors. It is important to ensure that the resident selects a preceptor with whom they feel comfortable, because the project will require frequent interactions with other project team members and open communication at all times. Ultimately, it is important for all parties to remember that this project is the resident’s, and he or she should have the final say in project and research team selection.

Many oncology residents enter their second year of training with a specific area of focus for their residency year and, potentially, their career. However, with the uncertainty of the job market from year to year, it is important that residents’ projects are diverse and that they exit the year as well-rounded oncology pharmacy clinicians. If the resident decides to complete a solid tumor medication usage evaluation, he or she may want to consider a research topic that is in another area, such as hematology or stem cell transplant. Ultimately, it is important for the resident to be passionate about the topic he or she chooses. The major research project will require countless hours to complete, and the project quality will likely correlate with the interest level the resident has. In addition, a resident will be most proud of a project that holds meaning for him or her.

Last, when considering project ideas, it is important for the resident to consider the feasibility of project completion within a 1-year time frame. Feasibility is often incorporated into project idea review by residency preceptors prior to the PGY-2 resident’s arrival; however, the true feasibility of an individual project will vary based on the caliber of the resident and his or her time management skills. Residents often are ambitious and want to complete meaningful, large-scale projects. Ambition in residents is highly desirable; however, it is very undesirable if the project cannot be completed as planned. Meetings with the entire project team at the beginning of the year can help establish timelines and outline project expectations to ensure the project is completed as planned.

Project Timeline

Establishing a timeline for project milestones—such as IRB submission, completion of data collection, meeting with statisticians, abstract submission to a national meeting, and manuscript preparation—can be extremely helpful for staying on track throughout the year. During the first year of residency, residents often focus on presentation of their project at a regional residency conference. One difference that PGY-2 oncology residents may face is the shortened time frame for project completion if the resident is expected to present his or her project results at the HOPA Annual Meeting in March. Residents should meet with his or her program director and research team early in the year to decide where the project will be presented, and the resident should adjust his or her timeline accordingly.

The research team also should decide early on whether manuscript submission to a peer-reviewed journal is the ultimate goal, and, if so, the target journal should be determined. There may be multiple journals to consider based on what the research project aims to accomplish. Members of the team may already have a target journal in mind; however, if that is not the case, the resident should research journals to determine the most appropriate one based on journal scope and impact factor, design of the research project, and project findings. Selecting the target journal early will be helpful to guide formatting when preparing the manuscript. Even if the project does not end up showing a significant change or difference, it is still important to consider submitting the manuscript to inform other practitioners and institutions of the findings.

Residents should schedule regular meetings with other project team members throughout the year to ensure adherence to the project timeline. It also may be advisable to keep minutes from each meeting and e-mail them to team members to make sure everyone is on the same page. It is important that IRB submission be completed early in the year because unexpected delays are a common obstacle. Most importantly, any delays the resident encounters during the year should be quickly communicated to the rest of the research team. Residency project mentors are selected to teach research skills and guide the res- ident through the project. Although more independence may be expected from a PGY-2 resident, mentors can likely help get the project back on track as long as there is open communication at all times and willingness from both parties to stay actively involved.

Take-Home Points

The PGY-2 pharmacy research project should be meaningful and contribute to the advancement of oncology pharmacy practice. When the project has been completed, it is important that these data are presented to the institution’s hospital staff. The goal behind completing the project is usually to improve or change a process at the hospital, and disseminating the findings will hopefully contribute to improving patient care. If a change is implemented as a result of the project, that information could be included in the manuscript so that other institutions can determine whether a similar change would be beneficial. Ultimately, the project may have the potential to make an impact both locally and nationally.

Residents should not lose track of the fact that this project is also a learning experience. Although project outcomes are certainly important, the research skills that can be learned from completing the project, no matter the topic, are at least as valuable. Residents will soon find themselves in the role of preceptor and project mentor to other residents and students. It is imperative that residents take full advantage of the top- notch physicians and experienced pharmacist preceptors with whom they have the opportunity to work and absorb all of the wisdom and knowledge that can be learned throughout the year.

Although it may be overwhelming to consider at the beginning of the year the entirety of the project that needs to be completed, focusing on smaller aspects of the research project timeline can help to restore sanity. The demands of PGY-2 certainly keep residents busy, and the year will fly by. Before residents realize it, they will be presenting the results of their long hours of research to their colleagues and wondering where the year went. I urge current residents to take advantage of meetings attended throughout the year to network with other current and future hematology/oncology pharmacists. Research projects require a lot of hard work, and maybe a sleepless night or two, but aspects of the project can certainly be fun, too!

Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) accounts for approximately 7% of newly diagnosed cases of non-Hodgkins lymphoma (NHL)1 and is the most common leukemia diagnosed in the Western world.2 CLL and SLL basically are the same disease and are treated similarly (unless otherwise indicated, however, this article will focus on SLL). With CLL, the disease burden primarily is in the bloodstream and bone marrow, and with SLL, the lymph nodes are involved.3 In the United States, 15,720 new diagnoses and 4,600 new deaths from CLL are predicted to occur in 2014.4 CLL is considered an indolent NHL with median age at diagnosis of 72 years.5 Signs and symptoms of this malignancy are vague and include weakness, weight loss, fever, night sweats, enlarged lymph nodes, and early satiety, but patients also may be asymptomatic when they are diagnosed.6

Diagnosis typically involves evaluation of the patients complete blood count (CBC) with differential, peripheral blood smear, immunophenotype of the circulating lymphocytes, and a thorough physical exam. Molecular cytogenetics are also performed to assess for specific gene mutations, such as deletion 11q or 17p, which are poor prognostic indicators. Unmutated IgVH (immunoglobulin heavy chain variable region) and high expression of Zap70 or CD38 also are poor prognostic factors. Bone-marrow biopsies are not required for diagnosis of CLL but may be completed in select patients. Excisional lymph node biopsies are required for the diagnosis of SLL.3,6,7

The National Cancer Institute–sponsored Working Group (NCI-WG) on CLL published revised guidelines for the diagnosis and management of this malignancy in 2008.7 To determine response to therapy (Table 1), assessment must include physical examination and evaluation of blood parameters. Response assessments should be conducted at least 2 months after treatment is completed. Stable disease (SD) is when patients do not have progressive disease (PD) but do not meet the criteria for complete response (CR) or partial response (PR). Relapse is described as evidence of disease progression after 6 or more months following an initial CR or PR. Refractory disease is expressed as failure to achieve a response or having disease progression within 6 months of the last treatment.3,7

Treatment Options

Treatment options for CLL have progressed during the past several decades, particularly in recent years. Several ongoing clinical trials are evaluating the efficacy of novel drug combination regimens and agents targeting unique pathways in B-cell malignancies. Treatment of this NHL subtype ranges from close observation with supportive-care measures to a variety of more intense therapeutic options. CLL is generally incurable, occurs in older patients, and progresses slowly. Therefore, it is often treated conservatively with careful consideration of the patients performance status and comorbidities.3,8

Patients who are asymptomatic may be observed but not treated until they become symptomatic, whereas patients with significant disease-related symptoms should be treated. Several pieces of clinical information should be considered if a patient is to be treated for CLL. Age, comorbidities, performance status, and presence of specific chromosomal abnormalities and gene mutations all should be evaluated when electing treatment regimens on an individual basis. Enrollment in a clinical trial should always be considered.3,6 Despite numerous available treatment options, some patients may be refractory to therapy, needing alternative treatment options, or require allogeneic hematopoietic stem cell transplantation (HSCT) for disease control. New agents have recently been added to the treatment armamentarium, which has improved patient options and prolonged survival.