Improving Communication in Clinical Research

Improving Communication in Clinical Research
By: Anatoly Gorkun, MD, PhD, Chartered MCIPD
            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 clinical research examples where communication problems affected deliverables or compliance. The principles of effective communication styles are discussed.

Introduction

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.

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:

(CTM’s Name) “is 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.”

The other clinical trial manager told the author:

“I know this CRA is new to the company and is still learning; however, with the upcoming data cleaning, I need your help.

I would suggest she has a co-monitoring visit with someone who is experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, and being able to address issues with the site staff.

I would appreciate your feedback and actions.”

Both studies were relatively similar, and in this specific example, the problem appeared to be the communication between the CRA and CTM.

The Importance of Communication in Clinical Research

There are various definitions of communication, including:

“The imparting or exchanging of information by speaking, writing, or using some other medium.” (oxforddictionaries.com)

“Two-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.” (businessdictionary.com).

The second definition is broader and reflects the nature of communication more accurately.

Poor communication in clinical research has many negative effects (Table 1) including stress, possible conflicts between clinical research professionals, and a breakdown in relationships. Other negative effects of poor communication are unmet expectations (ineffectiveness), wasted time because work is inefficient and must be re-done, non-compliance, possible harm to subjects, and possible invalidation of data.

As an example: an in-house CRA approached the line manager and said, “I’ve done what the project team wanted, but when I finished the task they said it was not what they expected.” The line manager asked if the CRA had checked with the project team before starting the task to clarify what they wanted. She said, “No, because the task seemed very clear.”

Communication that is free of assumptions is one of the characteristics of ideal communication (Table 2). It is important to listen, ask questions to ensure understanding of the task, agree to what needs to be done, and confirm the agreement. Communication is a two-way process that requires mutual understanding.

Successful Communication Methods

The most suitable method of communication depends upon the situation and to some extent, the receiver’s preferences. For urgent situations, a telephone call is best, followed by an email to summarize the call. The communicator should not bombard the person with emails, because he/she does not know whether the person is receiving and reading the emails. In some situations, more than one communication method is appropriate, such as emailing instructions and then following up with a telephone call.

Sometimes it happens that the site monitor and the in-house CRA as well as the project assistant may ask the research nurse at the site the same question. This may not be the most efficient approach. Communication should be streamlined in order to prevent it from being chaotic.

Example:

The following email communication is between a clinical trial manager (CTM) and a CRA on an urgent issue that required immediate attention. A delay in resolving the issue might affect deliverables and the company’s image.

  • CTM → CRA, February 21: Check if all Adverse Events were entered into eCRF. Urgent, due in 2 days. Table attached.
  • CTM → CRA, February 24: “A kind reminder, please.”
  • CTM → CRA, February 24: “Please send me your answers today.”
  • CTM → CRA, February 28: “I need your answers, please.”
  • CTM → CRA, March 01: “Client requested us to provide the answer. Please complete this task.”
  • CTM → CRA, March 06: “I need your answers URGENTLY please.”
  • CTM → CRA, March 06: “Please do it tomorrow and let me know.”
  • CRA → CTM, March 06: “I would do, but I don’t know what to check.”
  • CTM → CRA, March 06: “The table is attached.”
  • CTM → CRA, March 08: “Any news from the sites?”
  • CRA → CTM, March 08: “Hopefully tomorrow.”

The clinical trial manager sent the first email to the CRA on February 21st and did not receive a reply from the CRA until March 6th, nearly two weeks later. When the CRA responded that she did not know what to check, the CTM simply forwarded the same attachment. The CTM should have picked up the telephone and talked to the CRA.

Ideal communication is transparent. Transparency is:

“the perceived quality of intentionally shared information from a sender”

(Schnackenberg AK, Tomlinson EC. (March 2014). “Organizational transparency: a new perspective on managing trust in organization-stakeholder relationships,” Journal of Management. 10.1177/0149206314525202).

Transparency makes it easy for others to understand what actions have been completed and which actions need to be taken. It implies openness and accountability.

Example:

In another case, a project manager sent the following message to a line manager:

“As you know [name of CRA2] replaced [name of CRA1] at the end of March.

Unfortunately, by that date, the site performance decreased with late queries and SDV (Source  Data Verification) backlog due to pending monitoring visits.

Until today both sites still have not been visited and the plan is not available. I appreciate if you guarantee to have both sites visited by the end of April.”

The line manager spoke to the CRA, who said that the visits had been scheduled a long time ago. The project manager had been on holiday. When the project manager came back, he did not speak with the CRA about the status of the visits but instead escalated the issue.

Considerations in using appropriate communication include:

  • The purpose of the specific communication
  • How communicating will benefit the situation
  • Whether something different can be done
  • Whether alternative communication is necessary, and if so, the best method to use.

In the example, considering these four questions would have enabled the project manager to realize that talking directly to the CRA was the appropriate communication method for this situation.

Example:

In this case, the CRA needed advice from the CTM:

CRA: “I need to complete a number of overdue study-specific learning items on my LMS (Learning Management System) but I don’t have time. I am so busy.”

 CTM: “Then, do it wisely.”

The advice was not clear. Communication must also be concise. It is necessary to be clear about the purpose/goal of the message, to stick to the point, and to be brief.

Ideal communication is timely. In determining the best time for the message, the communicator must consider whether to communicate now or later. In some cases, it is better to wait and to communicate one message with another. It may also be helpful to pre-prepare the receiver of the communication with a brief heads-up.

Examples:

A CRA was having communication issues with two clinical research sites. At the same time, this CRA had to deliver a presentation at a departmental meeting and wanted feedback from the line manager. The line manager knew that the sites were struggling to work with this CRA because of his insufficient communication skills. The line manager decided to wait a couple of days to speak with the CRA about his presentation/communication skills and the issue with the sites at the same time, as that was a good chance to demonstrate the importance of expressing thoughts clearly and explicitly.

It is also important to acknowledge receipt of an email or other communication when we are not going to provide our answer immediately. For example:

“I’ve received your message. It will take me a week to collect the requested information. I’ll get back to you by …”

Ideal communication is diplomatic and constructive. It is okay to disagree with someone; however, communication should focus on a person’s opinion or approach and not insult the person. For example, instead of saying,

“I don’t agree with you …,” say something like, “May I suggest that we discuss more options …”

Example:

An in-house CRA sent the following email message to a research nurse:

“I sent you my request 2 weeks ago, and it’s complete silence from your side. I find it so frustrating because we need to close all queries by the end of this week.”

The research nurse said that she would not respond to requests like this. After coaching the in-house CRA on communication methods, there was a visible improvement noticed, and the relationship with the site improved.

It is always better to be constructive. Avoid being very direct or pushy, and suggest options instead of criticizing or expressing frustration.

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, “I hear what you say” means that the communicator accepts the other person’s point of view. In the United Kingdom, it may rather mean “I am not keen on discussing it further as I am not in agreement with this.” Also, accepting country or region-specific accents should be a part of cultural respect.

Ideal communication is also fair.

Example:

The following communication happened between a site monitor and a line manager.

Site monitor to line manager:

“I’m very busy and working very hard, however, I do not get enough support from the in-house CRA.”

The monitor’s line manager to in-house CRA’s line manager:

“I think that the in-house CRA might provide better support to the site monitor. Could you please check on the issue with the CRA’s performance and fix it?”

It turned out that the in-house CRA was doing a good job; however, the problem was that the site monitor needed to provide an explanation regarding the backlog of work that was created and decided to blame the in-house CRA for lack of support. Communication should be fair and should not blame other people unfairly.

Ideal communication is open, honest, and logical.

Examples:

The following examples highlight communication between a line manager and a direct report during two performance reviews and a 1:1 meeting.

Mid-year performance review meeting, Line Manager to a direct report:

“You are leading a very important project really well. It’s going to be a great year for you!”

Monthly one-to-one meetings throughout the year:

The project delivery was on time and good quality. Every month, the line manager confirmed that she was happy with all of the work and there was nothing to improve.

End-of-year performance review meeting, Line Manager to a direct report:

“You’ve been struggling to deliver the project and managing it below expectations.”

The end-of-year performance review feedback was not logical because the previous messages were all positive. Ideal communication should avoid misunderstanding, conflicts, and disappointment.

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.

The “rhetorical kipper” from Gareth Bunn can be used to plan communication. Using this model, communication is designed from the “tail of the kipper” and delivered from the “head.” After presenting the topic, three ideas or points are presented, and then finally, the request is made or the main message is delivered. The author’s direct reports found it useful to apply the rhetorical kipper method. Proper communication should be positive, assertive, and inspirational.

Case Study on Different Feedback

The case study presented at the beginning of this article illustrated different feedback from two clinical trial managers on the same CRA. One clinical trials managers stated that:

[CRA’s Name] “is perfectly performing as expected from an experienced CRA.

She 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.”

The other clinical trial manager told the author:

“I know this CRA is new to the company and is still learning; however, with the upcoming data cleaning, I need your help.

I would suggest that she has a co-monitoring visit with someone experienced. She needs to understand that this reconciliation is not just making a match between source data vs. case report form but also questioning what is being reported and identifying gaps, being able to address issues with the site staff. 

I would appreciate reviewing your feedback and actions.”

The reason for the different feedback was not different complexity of the studies but that the clinical trial manager was micro-managing the CRA. She had a different management style than the CRA was used to. The first clinical trial manager delegated the tasks and trusted the CRA to complete them. The second clinical trial manager required daily reports from the CRA, assuming that if there was no daily report, it meant that the job was not done. She also had negative experiences working with a previous CRA and assumed that the new CRA would act in the same way.

Thus, the second clinical trial manager’s style was based more on assumptions. After a root cause analysis of the situation, the CRA learned how to recognize different working styles and started working with the second CTM more efficiently.

Conclusion

Many skills are required for appropriate and effective communication (Table 3), including listening and observing, planning, and dealing with difficult situations dearly and empathetically. Methods of ensuring that communication is appropriate and effective include awareness of communication issues (Table 4). If we face a communication issue, we should not assume that it will disappear by itself. A root cause analysis should be done to determine the cause of the issue, and then a plan should be developed to manage the problem. The plan should include feedback to ensure that the other person understands and accepts the plan. Line managers can arrange for soft skills coaching and training for people who need to improve their communication skills. If nothing else works, such issues can be escalated.

In clinical research, it is important to monitor possible ineffective communication approaches and to proactively develop effective solutions to prevent negative consequences.

TABLE 1

The Effects of Poor Communication in Clinical Research

  • Stress
  • Possible conflicts and breakdowns in relationships
  • Unmet expectations (ineffectiveness)
  • Waste of time (inefficiency)
  • Non-compliance
  • Possible harm to subjects
  • Possible invalidation of data

TABLE 2

Ideal Communication

  • Assumption-free
  • Proper methods utilized
  • Transparent
  • Appropriate
  • Clear and concise
  • Timely
  • Diplomatic and constructive
  • Culturally respectful
  • Fair
  • Open, honest, and logical
  • Well-structured and compelling
  • Proper communication style

TABLE 3

Communication Skills

  • Listening and observing
  • Planning
  • Nonverbal communication (body language, facial countenance)
  • Negotiations
  • Influence
  • Dealing with difficult situations
  • Clarity
  • Friendliness
  • Empathy
  • Flexibility (open-mind)
  • Respect
  • Giving and receiving feedback

TABLE 4

Communication Strategies to Prevent or Fix Issues

  • Be aware of communication issues
  • Observe and discover issues
  • Do not assume that the issues disappear by themselves
  • Perform root-cause analysis 
  • Outline the plan for managing the issue, including:
    • Feedback, and how to ensure that it is understood and accepted
    • Soft skills coaching
    • Soft skills training
    • Escalating (if nothing else works)

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