5/21/2019
Effective Public speaking is integral to clinical research education/ communication. It impacts every aspect of study conduct.
The investigator educates the study patient on trial participation (via the informed consent) with an avid description of risks, benefits and patient responsibilities
The Clinical Research Associate (CRA) presents protocol procedural information to the study coordinators (SC) at the site initiation visit (SIV) to ensure accurate completion
The clinical trial manager (CTM) trains CRA staff on protocol endpoints to ensure credible data review/collection practices during monitoring visits
It is the responsibility of the researcher presenting study information to reach their audience, for retention and subsequent practice (by the attendees) will impact patient safety/study conduct. The pathway to audience engagement involves far more than strong content. How the researcher presents the message is often the deciding factor between retention and apathy for the recipients.
To ensure successful engagement requires awareness, knowledge and practice, or, the “AKP theory.”
Awareness: The presenter MUST know their audience. One would not likely discuss best carpet cleaning practices to a group of oncology physicians. However, a trained oncology monitor presenting information on a new safety portal at an industry meeting, could authentically include oncology immunotherapy best safety practices into the presentation if he/she had confirmed, through research, that the audience would include a majority of oncology physicians. The speaker has credible expertise and the additional information would be well received by the target audience. Transforming a lecture to an equitable discussion is achieved when the presenter does the research required to understand their target demographic.
As a Lead CRA, the more challenging study discussions are with key opinion leaders (KOL) who co-author the protocols we are required to discuss during site evaluation visits. How does one NOT patronize an esteemed KOL when reviewing study endpoints and eligibility criteria they designed? Advanced research is key. For example, I discovered that one investigator with whom I was scheduled to speak, (who was the primary protocol author) belonged to the same nonprofit research organization as I. Before the “official” evaluation visit study discussion commenced, I inquired if she had ever attended or spoken at the organization’s annual conference. Referencing this commonality created an open dialogue that facilitated an effective study discussion. It also did not hurt when I jokingly informed her that I was “going to review the study that you wrote, with you, to ensure your understanding.” She responded with laughter, which gained her interest in the remaining, unfamiliar topics I had to cover.
Knowledge: This is straightforward. Know your material. Review, flag and google unfamiliar terms, procedures and pronunciations. Practice inflection, and intonation, to place vocal emphasis on important sections or key areas. Know your material that you do not reduce the presentation to a rote recitation of each bullet point. You will lose/alienate your audience. Use bullets as talking points and involve the investigator/audience by asking questions of their expertise. Be confident in your knowledge without unrealistic expectations of near perfection. You may be fortunate enough to have an audience that knows much more about the therapeutic area than you. Use that to your advantage by drawing upon their experience. Ask pointed questions, encourage them to participate in the discussion and don’t forget to thank them for their contribution. Be humble, transparent, and write down every question they present to you. Never try to answer a question for which you do not know the answer/
Practice: A strong speaker will strive to deliver a professional product, and that requires continuous practice until the content is committed to memory. There is a methodical process to speech presentation. If you are the primary author, the first step in the process is slide creation, which lays the foundation of memory. It is more challenging when presenting another’s content. The next step is comprehensive review, and the sub step to that is critical matter familiarization. It is crucial to know the relevant endpoints from the slides to ensure an authentic discussion. The final step is audience involvement. ASK the audience questions to ensure their participation/contribution. Emphasize points that sparked previous interest. “One physician remarked that the exclusionary lab values seem a little stringent. What are your thoughts on that?”
A successful speaker is prepared, professional and dynamic. They will understand their audience and successfully involve them in the presentation. They let enthusiasm and transparency speak to their passion for the information presented, which promotes patient safety and study quality.
Elizabeth Weeks-Rowe
Elizabeth Weeks-Rowe, LVN, CCRA, has participated in clinical research for over 18.5 years, including work as a CRA, CRA Trainer, and CRA Manager. She has been an ACRP CCRA since 2004, and is a contributing writer to ACRP publications (ACRP blog, Clinical Researcher magazine) as well as authoring articles for such industry publications as Centerwatch Monthly, Centerwatch Weekly, PharmaTimes and the Journal of Best Research Practices. She authored the 2016 updates to “The CRA’s Guide to Monitoring Clinical Research” (Centerwatch), and the clinical research novella, “Clinical Research Trials and Triumphs; a heart-warming novel following a nurse’s journey into clinical research.” She is a speaker at both global and local clinical research industry conferences/meetings, as well as a part-time instructor for a clinical research training company. She currently works as a Principal CRA in study start up for a large CRO.
-We at Clinical Pathways would like to thank Elizabeth Weeks-Rowe for guest authoring this blog.
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