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A Practical Guide to Beginning Clinical Research

A Practical Guide to Beginning Clinical Research 150 150 Tiasha Letostak, PhD

You wouldn’t travel to unknown destinations without a map or GPS, so why do clinical research without a plan? Here’s what you need to know to get started.

Although the process for clinical research varies from institution to institution, the initial hurdles are often the same. From establishing clear protocols and outlining a detailed timeline to developing a reasonable budget and ensuring compliance with regulations, transitioning from the role of a physician with a research question to that of a principal investigator is a marathon, not a sprint.

This is why the support and resources that institutions offer — from their institutional review boards to database development — are vital to the success of clinical studies, especially for physicians who are just starting out. A key first step in designing or reviewing clinical research projects is the feasibility process. Feasibility involves assessing the study to determine budgetary and scientific adequacy, subject availability, staff availability, specific training or equipment needed, and how the study differs from the standard of care.

“We have instituted a mandatory feasibility meeting to review every clinical research study at our institution,” says Grace Wentzel, CCRP, director of Clinical Research Services at Nationwide Children’s Hospital. “Doing so ensures that details of the study, from the exact procedures that will occur and the costs involved to processes designed to eliminate the risk of a bill for a research procedure getting released to a subject’s insurance, are clearly outlined prior to study initiation.”

With respect to funding, clinical research can be industry sponsored, federally funded (NIH, CDC, etc.), funded by foundation or small organization grants, or internally funded by a department or intramural program.

“Regardless of the funding source or where the science is initiated, conducting a feasibility assessment for all clinical research studies is beneficial to both the investigator and the institution,” says William E. Smoyer, MD, vice president of Clinical and Translational Research in The Research Institute at Nationwide Children’s. “The feasibility assessment also serves as an initial evaluation of scientific importance — also known as the ‘so what?’ test — as well as assessing adequacy of study staff availability, and ensures there is an adequate study population and a sufficient budget.”

Once the study budget is established, IRB submission is approved, and contracts are reviewed, approved and signed by the institution, an initial launch or award meeting occurs and the sponsor hosts a site initiation visit, if applicable. This is the finish line of the feasibility process, and the beginning of study recruitment and enrollment.

The feasibility assessment involves determining scientific importance, staff availability, subject availability, and budgetary adequacy for a clinical research study. This checklist outlines the process prior to initiation of participant recruitment.

EXIT #1: SCIENTIFIC IMPORTANCE

Goals should be attainable with the proposed study design, the study should contribute to the literature, and there should be adequate scientific support from other investigators or potential collaborators.

  • Will this study further our knowledge about this disease and advance science?
  • Will it lead to academic gains or publication opportunities?
  • Do other investigators think the study is scientifically reasonable?  Are they supportive? Should they be invited to become collaborators on the study?
  • Will the study design meet its objectives?

EXIT #2: STAFFING AVAILABILITY

Assessing the adequacy of staff and resources is necessary and beneficial for both the principal investigator and the institution.

  • Does the principal investigator have enough time to commit to leading a trial?
  • Do colleagues and/or collaborators have enough time for the trial?
  • Who will manage the study?
  • Will institutional resources be used for clinical research? (E.g., study nurse and coordinator, regulatory/IRB coordinator.)
  • Will staff require training?

EXIT #3: SUBJECT AVAILABILITY

Subject availability is based on not only the particular study in question and its study design but whether there are competing studies recruiting the same patient population.

  • Is this a “safety only” study or a treatment study?
  • Are there any competing studies recruiting the same patient population?
  • Does the study minimize the risk to patients?
  • Will the participants have access to a novel treatment?
  • Do the benefits outweigh the risks of participation?
  • Will it be difficult to recruit subjects? Is a placebo involved?
  • How much does the study differ from standard of care?

EXIT #4: BUDGET DEVELOPMENT

The overall goal of budget development is to ensure that all costs will be covered, from costs associated with recruitment to those incurred for study procedures and participant incentives.

  • How many patients will be recruited?
  • Which procedures will occur at each visit?
  • Will the patient receive incentives?
  • Is pharmacy involved?

NEXT EXIT: INITIATE PARTICIPANT RECRUITMENT

About the author

Tiasha Letostak

Tiasha is the senior strategist for Clinical & Research Communications at Nationwide Children's Hospital. She provides assistance to investigators in The Research Institute and clinician-scientists at Nationwide Children’s for internal and external communication of clinical studies, peer-reviewed journal articles, grant awards and research news. She is also the editor-in-chief for Research Now, Nationwide Children's monthly, all-employee e-newsletter for research, as well as a writer for Pediatrics Nationwide.