{"id":330,"date":"2020-07-22T22:44:56","date_gmt":"2020-07-22T22:44:56","guid":{"rendered":"https:\/\/www.socra.org\/blog\/?p=330"},"modified":"2023-03-12T21:00:43","modified_gmt":"2023-03-12T21:00:43","slug":"improving-communication-in-clinical-research","status":"publish","type":"post","link":"https:\/\/www.socra.org\/blog\/improving-communication-in-clinical-research\/","title":{"rendered":"Improving Communication in Clinical Research"},"content":{"rendered":"<div class=\"wp-block-image\">\n<figure class=\"alignleft is-resized\"><a href=\"https:\/\/www.socra.org\/\"><img decoding=\"async\" loading=\"lazy\" src=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/07\/ClinicalResearchSocra-1024x576.jpg\" alt=\"Improving Communication in Clinical Research\" class=\"wp-image-331\" width=\"373\" height=\"210\" srcset=\"https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/07\/ClinicalResearchSocra-1024x576.jpg 1024w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/07\/ClinicalResearchSocra-300x169.jpg 300w, https:\/\/www.socra.org\/blog\/wp-content\/uploads\/2020\/07\/ClinicalResearchSocra-768x432.jpg 768w\" sizes=\"(max-width: 373px) 100vw, 373px\" \/><\/a><\/figure><\/div>\n\n\n<h5 class=\"has-text-align-center\">By: Anatoly Gorkun, MD, PhD, Chartered MCIPD<br> &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Senior Manager, Global Clinical Development, PPD UK <\/h5>\n\n\n\n<p>Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.<\/p>\n\n\n\n<!--more-->\n\n\n\n<h2>Introduction<\/h2>\n\n\n\n<p>Communication is a key tool for clinical researchers, yet problems due to inactive communication are common. It is important to monitor possible ineffective communication in order to develop effective solutions to proactively prevent the negative consequences of ineffective communication.<\/p>\n\n\n\n<p>Some time ago, the author received feedback from two clinical trial managers (CTM) on the same clinical research associate (CRA) at the same time. One clinical trial manager said:<\/p>\n\n\n\n<p>(CTM&#8217;s Name) \u201cis perfectly performing as expected from an experienced CRA. Her time has been allocated to manage a few difficult sites. Due to her learning agility and deep experience, the situation is improving now. She is a very good team player.\u201d <\/p>\n\n\n\n<p>The other clinical\ntrial manager told the author:<\/p>\n\n\n\n<p>\u201cI\nknow this CRA is new to the company and is still learning; however, with the\nupcoming data cleaning, I need your help.<\/p>\n\n\n\n<p>I\nwould suggest she has a co-monitoring visit with someone who is experienced.\nShe needs to understand that this reconciliation is not just making a match between\nsource data vs. case report form but also questioning what is being reported\nand identifying gaps, and being able to address issues with the site staff.<\/p>\n\n\n\n<p>I would appreciate your feedback and actions.\u201d <\/p>\n\n\n\n<p>Both\nstudies were relatively similar, and in this specific example, the problem\nappeared to be the communication between the CRA and CTM. <\/p>\n\n\n\n<h2>The Importance of Communication in Clinical Research<\/h2>\n\n\n\n<h4>There are various definitions of communication, including: <\/h4>\n\n\n\n<p>\u201cThe imparting or exchanging of information by speaking, writing, or using some other medium.\u201d (<a href=\"http:\/\/oxforddictionaries.com\" target=\"_blank\" rel=\"noreferrer noopener\" aria-label=\"oxforddictionaries.com (opens in a new tab)\">oxforddictionaries.com<\/a>)<\/p>\n\n\n\n<p>\u201cTwo-way process of reaching mutual understanding, in which participants not only exchange (encode-decode) information, news, ideas, and feelings but also create and share meaning.\u201d&nbsp;(businessdictionary.com).<\/p>\n\n\n\n<h4>The\nsecond definition is broader and reflects the nature of communication more accurately.<\/h4>\n\n\n\n<p>Poor\ncommunication in clinical research has many negative effects (Table 1)\nincluding stress, possible conflicts between clinical research professionals,\nand a breakdown in relationships. Other negative effects of poor communication\nare unmet expectations (ineffectiveness), wasted time because work is inefficient\nand must be re-done, non-compliance, possible harm to subjects, and possible\ninvalidation of data. <\/p>\n\n\n\n<p>As an example: an in-house CRA approached the line manager and said, \u201cI\u2019ve done what the project team wanted, but when I finished the task they said it was not what they expected.\u201d The line manager asked if the CRA had checked with the project team before starting the task to clarify what they wanted. She said, \u201cNo, because the task seemed very clear.\u201d<\/p>\n\n\n\n<p>Communication\nthat is free of assumptions is one of the characteristics of ideal\ncommunication (Table 2). It is important to listen, ask questions to ensure understanding\nof the task, agree to what needs to be done, and confirm the agreement.\nCommunication is a two-way process that requires mutual understanding.<\/p>\n\n\n\n<h2>Successful Communication Methods<\/h2>\n\n\n\n<p>The\nmost suitable method of communication depends upon the situation and to some\nextent, the receiver\u2019s preferences. For urgent situations, a telephone call is\nbest, followed by an email to summarize the call. The communicator should not\nbombard the person with emails, because he\/she does not know whether the person\nis receiving and reading the emails. In some situations, more than one\ncommunication method is appropriate, such as emailing instructions and then\nfollowing up with a telephone call.<\/p>\n\n\n\n<p>Sometimes\nit happens that the site monitor and the in-house CRA as well as the project\nassistant may ask the research nurse at the site the same question. This may\nnot be the most efficient approach. Communication should be streamlined in\norder to prevent it from being chaotic.<\/p>\n\n\n\n<h4><em>Example:<\/em><\/h4>\n\n\n\n<p>The\nfollowing email communication is between a clinical trial manager (CTM) and a\nCRA on an urgent issue that required immediate attention. A delay in resolving\nthe issue might affect deliverables and the company\u2019s image.<\/p>\n\n\n\n<ul>\n<li>CTM \u2192 CRA, February 21: Check if all Adverse      Events were entered into eCRF. Urgent, due in 2 days. Table attached.<\/li>\n\n\n\n<li>CTM \u2192 CRA, February 24: \u201cA kind reminder, please.\u201d <\/li>\n\n\n\n<li>CTM \u2192 CRA, February 24: \u201cPlease send me your answers today.\u201d <\/li>\n\n\n\n<li>CTM \u2192 CRA, February 28: \u201cI need your answers, please.\u201d<\/li>\n\n\n\n<li>CTM \u2192 CRA, March 01: \u201cClient requested us to provide the answer. Please complete this task.\u201d <\/li>\n\n\n\n<li>CTM \u2192 CRA, March 06: \u201cI need your answers URGENTLY please.\u201d <\/li>\n\n\n\n<li>CTM \u2192 CRA, March 06: \u201cPlease do it tomorrow and let me know.\u201d<\/li>\n\n\n\n<li>CRA \u2192 CTM, March 06: \u201cI would do, but I don\u2019t know what to check.\u201d <\/li>\n\n\n\n<li>CTM \u2192 CRA, March 06: \u201cThe table is attached.\u201d<\/li>\n\n\n\n<li>CTM \u2192 CRA, March 08: \u201cAny news from the sites?\u201d<\/li>\n\n\n\n<li>CRA \u2192 CTM, March 08: \u201cHopefully tomorrow.\u201d<\/li>\n<\/ul>\n\n\n\n<p>The\nclinical trial manager sent the first email to the CRA on February 21st and did\nnot receive a reply from the CRA until March 6<sup>th<\/sup>, nearly two weeks\nlater. When the CRA responded that she did not know what to check, the CTM\nsimply forwarded the same attachment. The CTM should have picked up the\ntelephone and talked to the CRA.<\/p>\n\n\n\n<h4>Ideal communication is transparent. Transparency\nis:<\/h4>\n\n\n\n<p>\u201cthe\nperceived quality of intentionally shared information from a sender\u201d<\/p>\n\n\n\n<p>(Schnackenberg AK, Tomlinson EC. (March 2014).\n\u201cOrganizational transparency: a new perspective on managing trust in\norganization-stakeholder relationships,\u201d <em>Journal\nof Management<\/em>. 10.1177\/0149206314525202).<\/p>\n\n\n\n<p>Transparency\nmakes it easy for others to understand what actions have been completed and which\nactions need to be taken. It implies openness and accountability.<\/p>\n\n\n\n<h4><em>Example:<\/em><\/h4>\n\n\n\n<p>In another case, a project manager sent the\nfollowing message to a line manager:<\/p>\n\n\n\n<p>\u201cAs\nyou know [name of CRA2] replaced [name of CRA1] at the end of March. <\/p>\n\n\n\n<p> Unfortunately, by that date, the site performance decreased with late queries and SDV (Source&nbsp; Data Verification) backlog due to pending monitoring visits. <\/p>\n\n\n\n<p>Until\ntoday both sites still have not been visited and the plan is not available. I\nappreciate if you guarantee to have both sites visited by the end of April.\u201d<\/p>\n\n\n\n<p>The\nline manager spoke to the CRA, who said that the visits had been scheduled a\nlong time ago. The project manager had been on holiday. When the project\nmanager came back, he did not speak with the CRA about the status of the visits\nbut instead escalated the issue.<\/p>\n\n\n\n<h4>Considerations in using appropriate communication\ninclude:<\/h4>\n\n\n\n<ul>\n<li>The purpose of the specific\n     communication<\/li>\n\n\n\n<li>How communicating will benefit the\n     situation <\/li>\n\n\n\n<li>Whether something different can be done<\/li>\n\n\n\n<li>Whether alternative communication is necessary,\n     and if so, the best method to use.<\/li>\n<\/ul>\n\n\n\n<p>In\nthe example, considering these four questions would have enabled the project\nmanager to realize that talking directly to the CRA was the appropriate\ncommunication method for this situation.<\/p>\n\n\n\n<h4><em>Example: <\/em><\/h4>\n\n\n\n<p>In this case, the CRA needed advice from the CTM:<\/p>\n\n\n\n<p>CRA:\n\u201cI need to complete a number of overdue study-specific learning items on my LMS (Learning Management System) but I don\u2019t have time. I am so busy.\u201d<br><\/p>\n\n\n\n<p>&nbsp;CTM: \u201cThen, do it wisely.\u201d<\/p>\n\n\n\n<p>The\nadvice was not clear. Communication must also be concise. It is necessary to be\nclear about the purpose\/goal of the message, to stick to the point, and to be\nbrief.<\/p>\n\n\n\n<p>Ideal\ncommunication is timely. In determining the best time for the message, the\ncommunicator must consider whether to communicate now or later. In some cases,\nit is better to wait and to communicate one message with another. It may also\nbe helpful to pre-prepare the receiver of the communication with a brief\nheads-up.<\/p>\n\n\n\n<h4><em>Examples: <\/em><\/h4>\n\n\n\n<p>A CRA was having communication issues with two clinical\nresearch sites. At the same time, this CRA had to deliver a presentation at a\ndepartmental meeting and wanted feedback from the line manager. The line\nmanager knew that the sites were struggling to work with this CRA because of his\ninsufficient communication skills. The line manager decided to wait a couple of\ndays to speak with the CRA about his presentation\/communication skills and the\nissue with the sites at the same time, as that was a good chance to demonstrate\nthe importance of expressing thoughts clearly and explicitly.<\/p>\n\n\n\n<p>It is also important to acknowledge receipt of an\nemail or other communication when we are not going to provide our answer\nimmediately. For example:<\/p>\n\n\n\n<p>\u201cI\u2019ve received your message. It will take me a week\nto collect the requested information. I\u2019ll get back to you by \u2026\u201d<\/p>\n\n\n\n<p>Ideal communication is diplomatic and constructive. It is okay to disagree with someone; however, communication should focus on a person\u2019s opinion or approach and not insult the person. For example, instead of saying, <\/p>\n\n\n\n<p>\u201cI\ndon\u2019t agree with you \u2026,\u201d say something like, \u201cMay I suggest that we discuss\nmore options \u2026\u201d <\/p>\n\n\n\n<h4><em>Example:<\/em><\/h4>\n\n\n\n<p>An in-house CRA sent the following email message to\na research nurse: <\/p>\n\n\n\n<p>\u201cI sent you my request 2 weeks ago, and it\u2019s\ncomplete silence from your side. I find it so frustrating because we need to\nclose all queries by the end of this week.\u201d<\/p>\n\n\n\n<p>The\nresearch nurse said that she would not respond to requests like this. After\ncoaching the in-house CRA on communication methods, there was a visible improvement\nnoticed, and the relationship with the site improved.<\/p>\n\n\n\n<p>It\nis always better to be constructive. Avoid being very direct or pushy, and\nsuggest options instead of criticizing or expressing frustration.<\/p>\n\n\n\n<p>Ideal communication must be culturally respectful since clinical research is conducted internationally. Culturally respectful communication helps to avoid misunderstanding, to establish rapport, to build better relationships, and to facilitate more efficient work. Even among English-speaking countries, words or phrases can have slightly different meanings. For example, in the United States, \u201cI hear what you say\u201d means that the communicator accepts the other person\u2019s point of view. In the United Kingdom, it may rather mean \u201cI am not keen on discussing it further as I am not in agreement with this.\u201d Also, accepting country or region-specific accents should be a part of cultural respect.  <\/p>\n\n\n\n<p>Ideal\ncommunication is also fair.<\/p>\n\n\n\n<h4><em>Example:<\/em><\/h4>\n\n\n\n<p>The following communication happened between a site\nmonitor and a line manager.<\/p>\n\n\n\n<p>Site monitor to line manager: <\/p>\n\n\n\n<p>\u201cI\u2019m very busy and working very hard, however, I do not get enough support from the in-house CRA.\u201d <\/p>\n\n\n\n<p>The\nmonitor\u2019s line manager to in-house CRA\u2019s line manager: <\/p>\n\n\n\n<p>\u201cI think that the in-house CRA might provide better support to the site monitor. Could you please check on the issue with the CRA\u2019s performance and fix it?\u201d <\/p>\n\n\n\n<p>It\nturned out that the in-house CRA was doing a good job; however, the problem was\nthat the site monitor needed to provide an explanation regarding the backlog of\nwork that was created and decided to blame the in-house CRA for lack of support.\nCommunication should be fair and should not blame other people unfairly.<\/p>\n\n\n\n<p>Ideal\ncommunication is open, honest, and logical. <\/p>\n\n\n\n<h4><em>Examples:<\/em><\/h4>\n\n\n\n<p>The following examples highlight communication\nbetween a line manager and a direct report during two performance reviews and a\n1:1 meeting.<\/p>\n\n\n\n<p><em>Mid-year performance review\nmeeting, Line Manager to a direct report:<\/em><\/p>\n\n\n\n<p>\u201cYou\nare leading a very important project really well. It\u2019s going to be a great year\nfor you!\u201d<\/p>\n\n\n\n<p><em>Monthly one-to-one meetings\nthroughout the year:<\/em><\/p>\n\n\n\n<p>The\nproject delivery was on time and good quality. Every month, the line manager confirmed\nthat she was happy with all of the work and there was nothing to improve.<\/p>\n\n\n\n<p><em>End-of-year performance\nreview meeting, Line Manager to a direct report:<\/em><\/p>\n\n\n\n<p>\u201cYou\u2019ve been struggling to deliver the project and managing\nit below expectations.\u201d<\/p>\n\n\n\n<p>The\nend-of-year performance review feedback was not logical because the previous messages\nwere all positive. Ideal communication should avoid misunderstanding,\nconflicts, and disappointment.<\/p>\n\n\n\n<p>Ideal communication is well-structured and compelling. Communicators should try not to tell a long story that makes it difficult for the receiver to determine what the communicator needs. This is important in everyday life with everyone, including communication with senior leaders and clinical investigators, both of whom are usually very busy. <\/p>\n\n\n\n<p>The\n\u201crhetorical kipper\u201d from Gareth Bunn can be used to plan communication. Using\nthis model, communication is designed from the \u201ctail of the kipper\u201d and\ndelivered from the \u201chead.\u201d After presenting the topic, three ideas or points\nare presented, and then finally, the request is made or the main message is\ndelivered. The author\u2019s direct reports found it useful to apply the rhetorical\nkipper method. Proper communication should be positive, assertive, and inspirational.<\/p>\n\n\n\n<p>Case Study on Different Feedback<\/p>\n\n\n\n<p>The\ncase study presented at the beginning of this article illustrated different\nfeedback from two clinical trial managers on the same CRA. One clinical trials managers\nstated that:<\/p>\n\n\n\n<p>[CRA\u2019s Name] \u201cis perfectly\nperforming as expected from an experienced CRA. <\/p>\n\n\n\n<p>She\nhas been allocated to manage a few difficult sites. Due to her learning agility\nand deep experience, the situation is improving now. She is a very good team\nplayer.\u201d <\/p>\n\n\n\n<p>The other clinical\ntrial manager told the author:<\/p>\n\n\n\n<p>\u201cI\nknow this CRA is new to the company and is still learning; however, with the\nupcoming data cleaning, I need your help.<\/p>\n\n\n\n<p>I\nwould suggest that she has a co-monitoring visit with someone experienced. She\nneeds to understand that this reconciliation is not just making a match between\nsource data vs. case report form but also questioning what is being reported\nand identifying gaps, being able to address issues with the site staff.&nbsp; <\/p>\n\n\n\n<p>I would appreciate reviewing your feedback and\nactions.\u201d <\/p>\n\n\n\n<p>The reason for the different\nfeedback was not different complexity of the studies but that the clinical\ntrial manager was micro-managing the CRA. She had a different management style\nthan the CRA was used to. The first clinical trial manager delegated the tasks\nand trusted the CRA to complete them. The second clinical trial manager\nrequired daily reports from the CRA, assuming that if there was no daily report,\nit meant that the job was not done. She also had negative experiences working\nwith a previous CRA and assumed that the new CRA would act in the same way.<\/p>\n\n\n\n<p>Thus, the second clinical\ntrial manager\u2019s style was based more on assumptions. After a root cause\nanalysis of the situation, the CRA learned how to recognize different working\nstyles and started working with the second CTM more efficiently.<\/p>\n\n\n\n<h2>Conclusion<\/h2>\n\n\n\n<p>Many\nskills are required for appropriate and effective communication (Table 3),\nincluding listening and observing, planning, and dealing with difficult\nsituations dearly and empathetically. Methods of ensuring that communication is\nappropriate and effective include awareness of communication issues (Table 4). If\nwe face a communication issue, we should not assume that it will disappear by\nitself. A root cause analysis should be done to determine the cause of the\nissue, and then a plan should be developed to manage the problem. The plan\nshould include feedback to ensure that the other person understands and accepts\nthe plan. Line managers can arrange for soft skills coaching and training for\npeople who need to improve their communication skills. If nothing else works,\nsuch issues can be escalated.<\/p>\n\n\n\n<p>In clinical research, it is important to monitor possible ineffective communication approaches and to proactively develop effective solutions to prevent negative consequences.<\/p>\n\n\n\n<h3>TABLE 1<\/h3>\n\n\n\n<h2>The Effects of Poor Communication in Clinical Research<\/h2>\n\n\n\n<ul>\n<li>Stress<\/li>\n\n\n\n<li>Possible conflicts and breakdowns in relationships<\/li>\n\n\n\n<li>Unmet expectations (ineffectiveness)<\/li>\n\n\n\n<li>Waste of time (inefficiency)<\/li>\n\n\n\n<li>Non-compliance<\/li>\n\n\n\n<li>Possible harm to subjects<\/li>\n\n\n\n<li>Possible invalidation of data<\/li>\n<\/ul>\n\n\n\n<h3>TABLE 2<\/h3>\n\n\n\n<h2>Ideal Communication<\/h2>\n\n\n\n<ul>\n<li>Assumption-free <\/li>\n\n\n\n<li>Proper methods utilized <\/li>\n\n\n\n<li>Transparent <\/li>\n\n\n\n<li>Appropriate <\/li>\n\n\n\n<li>Clear and concise <\/li>\n\n\n\n<li>Timely<\/li>\n\n\n\n<li>Diplomatic and constructive<\/li>\n\n\n\n<li>Culturally respectful <\/li>\n\n\n\n<li>Fair <\/li>\n\n\n\n<li>Open, honest, and logical<\/li>\n\n\n\n<li>Well-structured and compelling<\/li>\n\n\n\n<li>Proper communication style<\/li>\n<\/ul>\n\n\n\n<h3>TABLE 3<\/h3>\n\n\n\n<h2>Communication Skills<\/h2>\n\n\n\n<ul>\n<li>Listening and observing<\/li>\n\n\n\n<li>Planning<\/li>\n\n\n\n<li>Nonverbal communication (body language,\n     facial countenance) <\/li>\n\n\n\n<li>Negotiations<\/li>\n\n\n\n<li>Influence<\/li>\n\n\n\n<li>Dealing with difficult situations<\/li>\n\n\n\n<li>Clarity<\/li>\n\n\n\n<li>Friendliness<\/li>\n\n\n\n<li>Empathy<\/li>\n\n\n\n<li>Flexibility (open-mind)<\/li>\n\n\n\n<li>Respect<\/li>\n\n\n\n<li>Giving and receiving feedback<\/li>\n<\/ul>\n\n\n\n<h3>TABLE 4<\/h3>\n\n\n\n<h2>Communication Strategies to Prevent or Fix Issues<\/h2>\n\n\n\n<ul>\n<li>Be aware of communication issues<\/li>\n\n\n\n<li>Observe and discover issues<\/li>\n\n\n\n<li>Do not assume that the issues disappear\n     by themselves<\/li>\n\n\n\n<li>Perform root-cause analysis&nbsp; <\/li>\n\n\n\n<li>Outline the plan for managing the\n     issue, including:\n<ul>\n<li>Feedback, and how to ensure that it is\n      understood and accepted<\/li>\n\n\n\n<li>Soft skills coaching<\/li>\n\n\n\n<li>Soft skills training<\/li>\n\n\n\n<li>Escalating (if nothing else works)<\/li>\n<\/ul>\n<\/li>\n<\/ul>\n","protected":false},"excerpt":{"rendered":"<p>By: Anatoly Gorkun, MD, PhD, Chartered MCIPD &nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp;&nbsp; Senior Manager, Global Clinical Development, PPD UK Abstract: Effective communication skills in clinical research are vitally important. Due to many conflicting priorities however, clinical research professionals may not have time to manage soft skills. This increases the danger that something may go wrong. This article highlights real-life &hellip; <\/p>\n<p><a href=\"https:\/\/www.socra.org\/blog\/improving-communication-in-clinical-research\/\" class=\"more-link\">Continue reading <span class=\"screen-reader-text\">Improving Communication in Clinical Research<\/span> &rarr;<\/a><\/p>\n","protected":false},"author":2,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"om_disable_all_campaigns":false,"_monsterinsights_skip_tracking":false,"_monsterinsights_sitenote_active":false,"_monsterinsights_sitenote_note":"","_monsterinsights_sitenote_category":0},"categories":[35,40,44],"tags":[83,8,82,84],"yoast_head":"<!-- This site is optimized with the Yoast SEO plugin v15.6.2 - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>Improving Communication in Clinical Research - SOCRA Blog<\/title>\n<meta name=\"description\" content=\"Effective communication skills in clinical research are vitally important. 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