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Jill Demirci, PhD, Alejandro Hoberman, MD, and Kumaravel Rajakumar, MD.
Jill Demirci, PhD, RN, IBCLC: Dr. Hoberman and Dr. Rajakumar, thank you for sharing your insights in what it takes to succeed in conducting a clinical research project.
Kumaravel Rajakumar, MD, MS: Jill, in my view, to succeed in completing a clinical research project, the investigator should have a hands-on approach and be actively engaged. The interaction between the investigator and the family at the beginning of the study is important for the participants’ successful completion of the trial. The investigator is the one with the most comprehensive understanding of the nuances of the study including what is being studied, who is being studied, and why is the study being conducted. That’s why it is important for the investigator to actively engage the family early in the study.
Alejandro Hoberman, MD: It is during that initial interaction that the investigator can introduce the research team and emphasize to the family that the health and safety of their child during the research is everyone’s top priority. As investigators, we need to ensure that the family has full understanding of the scope of their commitment for participating in the research.
Rajakumar: I believe that our engagement can be further enhanced if we are the ones obtaining informed consent. The informed consent process represents the most critical step in participation in clinical research. In pediatric research, the participant and the parent need to fully understand what their commitment to the research program is. Also, the parent should be made aware that the investigator will be immediately available if they have any questions, needs or concerns.
Hoberman: During the consent process or the first meeting, we have the opportunity to highlight the important steps in the clinical research program. Doing this can potentially impact the adherence of participants with study procedures. In our experience, the immediate availability of the investigator via cell phone throughout the study is a must! Parents need to be able to reach out if they have questions. We should never use voicemail or central numbers to substitute for immediate availability.
Rajakumar: In our research studies, we try our best to foster active engagement and interaction with participants at each study visit. We make an effort to meet with families and check on their progress and thank them for their participation. This interaction serves to positively reinforce adherence and address ongoing questions or concerns the family may have. Again, it also provides reassurance that the child’s health and safety is our goal. This, we believe, will enhance the overall parental trust in the research.
Hoberman: We also make an effort to meet with the family at the exit visit to bring closure to their research participation. At that time, we thank them for their time and help with the project. It truly could not have been done without them. We review pertinent results and required follow-up the child may need. We emphasize that we are available to review any follow-up testing resulting from their research participation and that we would be happy to guide them, or their primary care providers, in further management.
Rajakumar: Jill, to summarize, the key points for successful completion of a research project are that the investigator is actively engaged at the beginning, during, and at the conclusion of the study.
Return to “For Clinical Researchers”
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