By Fiona Wallace, director, FW Clinical Research Ltd.
“The single biggest problem in communication is the illusion that it has taken place.” – George Bernard Shaw.
There are some easy ways to improve communication on your clinical trial. But before we get into that, let’s consider how poor communication can derail your clinical trial.
How we communicate with each other affects the success of a clinical trial. Following are some examples of poor communication, when the message between the transmitter and the receiver has not been fully understood by one or both parties.
- Protocol violations: The more complex and technical the protocol, the more likely deviations and violations will occur. Consistency in trial assessments is key to patient safety and data integrity. If you are not confident your site staff can carry out a procedure as defined in the protocol, communication and understanding are needed. For example, on one of my Phase 2b studies, an ethics committee did not approve a study because they thought the patient instruction leaflet was too complicated for the local population to understand.
- Unhappy key stakeholders not informed of critical study changes. One example is when a trial has to be stopped, but all parties are not informed.
- Low retention rate: Patients have received no or limited communication regarding their trial participation. Hence, they are more likely to drop out.
- Low recruitment rate: The right communication avenues are not utilized. An example is social media platforms, which are popular recruitment tools.
Drowning In Emails
The methods of communication are important. Let’s discuss e-mail. Is email a friend or foe? Both!
Email can help your study or hinder it, depending on how the study team uses it. The most common complaint I hear from colleagues is the sheer volume of emails they receive on a daily basis. Let me share this alarming statistic: 54 percent of American workers left vacation time unused in 2017. The top barrier to not using this vacation time was “fear of returning to a mountain of work” (43 percent).1 I think it is fair to assume the mountain of work includes opening, reading, and managing emails on that dreaded first day back to work.
The worst-case scenario could be that something urgent and important is hidden amongst the messages, e.g., a potential safety issue on your clinical trial. This is compounded if you have several highlighted urgent emails in your inbox. Which email is more urgent than the others?
Why Reliance On Email As The Main Communication Method Has Increased
- With advances in clinical trials and new populations, many global studies have remote teams working in different time zones. Email can seem a good way to distribute a consistent message to several parties. The problems start when this generates online discussions and questions, developing into a large email thread open to misinterpretation. A better option could be to take it offline and add it to the next weekly team meeting.
- "If it isn’t documented, it didn’t happen” is a mantra often heard in the clinical trial industry. And rightly so, since failure to establish and/or follow a written procedure has serious consequences.2 However, there is a significant difference between filing 20 emails in the study documentation file about which is the best room to hold the next study meeting in and a pivotal discussion on reference safety information. All clinical research personnel need to understand what documentation is significant. Inexperience can often lead to confusion, resulting in large volumes of text entered in reports or used in emails, placing the responsibility on the receiver to determine their importance.
For example, I used to review my Phase 4 clinical research associate (CRA) teams’ monitoring reports, and one CRA was extremely diligent. She documented everything she did at their monitoring visit, down to listing every monitoring and source data verification discrepancy. There was no need for this level of detail, as only significant issues needed to be documented. Reviewing her reports took me four times as long as that of another team member. This would affect the study timelines and budget.
- There is evidence the millennial generation prefers electronic communication over other methods such as telephone and face-to-face. This is the first generation for which the Internet and email is a fixture of their work life.3
- The availability of the email recipient: If you are always in meetings and cannot be reached on the telephone or otherwise, sending an email is one way to reach you. But there are no guarantees the message has been received and read, regardless of read receipts. A director of clinical operations at a global biotech explained: “For some of my team, there is an overwhelming urge to get stuff off their to-do list, as if carrying over an unfinished task to the next day seems like failure to them. So they will send me an email about it.”
- Mind-set of the email sender: some email users' working cultures are focused on over-productivity, prizing hours worked and the number of emails sent above true productivity.
- Passive nature of the receiver: If you are receiving too many emails, remember you are not a passive victim. There are proactive steps you can take to reduce the amount of emails you receive, listed in the next section.
How To Improve And Reduce Email Communication
- Don’t ask the other person if they understand. Chances are, if they do not, they will not reveal this, especially to their project manager or sponsor. It would be better to ask them to explain it back to you in their own words; this will allow you to truly gauge their level of understanding.
- Are you asked the same questions over and over? Be proactive, generate a FAQs document, or respond with the old favorite, “Have you read the protocol to see if it is explained in there?” Good managers enable and foster a proactive approach within their teams.
- Explain the reason behind a course of action to aid the understanding. For example, a statement such as “All the sites need to be contacted ASAP for a medication recall” may cause undue panic if the reason behind it is related to manageable medication expiry dates.
- Have a communication plan that the whole team can access. This would detail who is the primary contact for each function, who is responsible for the contact, which methods are used, and frequency of communication (e.g., status reports, face-to-face meetings, teleconferences, supporting documentation). Include all key stakeholders in this plan.
- Make it clear to your team how communication should work on the study/project and the expectations. For example, non-urgent study discussion should be scheduled for weekly team conferences, and remind the team to check the FAQs document and protocol regarding common study questions.
- Consider email for sharing information only, as opposed to opening up lengthy discussion threads leading to misinterpretation.
- For remote teams, use strategies such as team newsletters with study updates. Use photos when possible to foster team ethos.
- If your study budget allows, utilize co-visits.
- Explore Facetime and Skype as options.
Insiders’ Perspectives On Communication Issues
In my own informal survey with peers and colleagues, I received varied feedback about communication. One of my first project managers (PMs), who is now a pharma VP, had this to say:
“Every day we still make expensive mistakes because of poor communication, despite the available technology. My view is we expect people to do more, so people take shortcuts. Do I read every email I receive in detail? No. I read one word in four and fill in the gaps. I receive answers that miss the question because the person I wrote to is also reading one word in four.
Clinical research projects are always expected to start immediately, so PMs may not have time to plan properly. Team turnover is endemic, and the people joining the team are already overworked, so they don’t have the time to truly understand what is going on. As an industry we are breaking the work down into ever-smaller pieces. Startup and regulatory teams focus on one small section of multiple projects, so they often have limited knowledge of the project’s objective, and, of course, there is always, ‘It’s not my job.’
We work in an environment dominated by American English. The words and phrases used do not easily translate for a global audience. I was once on a global conference call when an American colleague said, ‘We need to get this train out of the station.' A colleague from Germany asked, 'Why are we catching the train? Where are we going?’
So, in short, my view is we need a little bit more time. We need to spend more time planning how we will manage project communication. We need to communicate in a way that works in a global environment, where people of different countries, ages, and background communicate in different ways.”
Another colleague, who is the global head of training at a CRO, offered this:
“I assisted with the setup of a virtual investigator meeting. Due to the nature of the details beforehand, attendance was low and there were some unexpected attendees, which made everyone nervous. Afterward I received an aggressive email from the PM about poor management and poor attendance and that the client was unhappy. So, I took a moment to type an email in response, rebuffing all the concerns. So, here I am, email written and ready to send, and I stopped. I had no concerns about the email contents; it was all accurate, but it didn’t add anything to the situation. It wasn’t going to help the PM at this moment. So I spoke to my line manager [LM] for advice, and subsequently set up a call early the next morning. As it turns out, the PM started by apologizing for the email and said she should have paused before sending it. Had I sent that email, we would have ended up in a war of words on emails and probably a broken internal relationship. As it happens, going back to basics, a good, old-fashioned chat, worked wonders.”
One of my previous LMs, who is now a senior director had this advice: “The sentence ‘I told you Mary did not steal the money,' when written, is not the same as when spoken, as emphasis on any one spoken word in the sentence will change its whole meaning, e.g., ‘I told you Mary did not steal the money,’ compared to ‘I told you Mary did not steal the money.’ Also, if you have to ask for or provide an explanation of the same thing twice in email, pick up the phone!”
Finally, consider the 1 percent rule: if you could improve your communication by one percent, what would that look like? Some examples may be walking to another office to speak to someone instead of using the telephone; calling your research nurse instead of emailing him; and communicating some good news, such as an important milestone that was met. Small changes make a difference.
- Integrated Addendum to ICH E6(R1): Guideline for Good Clinical Practice E6(R2)
- The Work-Life Imbalance Report. Workfront. April 2015. https://www.workfront.com/wp-content/uploads/sites/5/2015/04/workfront-work-life-imbalance-report.pdf
About The Author:
Fiona Wallace, director at FW Clinical Research Ltd, has worked in global CRO and pharma for 18 years. Her experience spans many countries including India, South Africa, U.S., Europe, and Central and Eastern Europe in Phase 1–4 studies in oncology, ophthalmology, erectile dysfunction, and rheumatoid arthritis. She specializes in developing high value retention learning solutions by utilizing her breadth of experience in project and CRA management, global clinical regulatory training, inspection readiness management, and provision of client solutions to improve staff retention and engagement. Her latest project is to open up the discussion of mental health in the clinical research workplace, with the goal of improving the quality of life for everyone working in the spectrum of clinical research. Wallace can be reached at firstname.lastname@example.org.