Communication or lack thereof, miscommunication and poor communication.

It is considered a soft skill but in clinical trials it is a critical skill.

I have identified 5 stages in the clinical development cycle where communication is of critical importance.

1. Protocol development

Don’t wait until your protocol is finalized before seeking input from key stakeholders such as an investigator ‘on the ground’ (not just the KOL in an academic institution), a research coordinator and a patient representative. You may not like their feedback and some of the procedures may be non-negotiable but listen to them. Isn’t better to modify the protocol now before it is finalized rather than having to do an amendment in 6 months’ time?

2. The start-up process

This is when the CRO acting for the Sponsor can make a good impression. Provide clear, detailed instructions on what exactly needs to be completed where. Consider getting on the phone with the site before they return/upload their documents and review them together. Whether you are at the site or at the CRO, respond promptly to calls/e-mails. Do get on the phone periodically to build that relationship. Even if a technological solution is being used, you each only have one opportunity to make a good first impression. If there is going to be a delay, let people know. Keep them engaged!

3. The informed consent process

The Common Rule changes have finally come into effect, but the changes only apply to federally funded research. However, it may influence FDA regulations down the road. Informed consents must have a concise summary of “key information” and the information presented in sufficient detail that a “reasonable person” can make an informed decision. I was an IRB member in the early 2000s and a lay summary was routinely attached to the informed consents for the benefit of the lay members of the IRB! We thought it was ironic that Sponsors would not agree to the same being provided to research subjects. Because of the current length and complexity of industry consents (average length now 22 pages according to John Hopkins), I fear that the people obtaining consent don’t have enough time to spend with the patient to make sure they fully understand what study participation entails and the patient or family member is overwhelmed by the volume of information. It is easier to just say ‘No’ than ask questions of someone who is ‘busy’.

4. The Screening period

Site personnel will have questions about eligibility, about study processes etc. It is critical that a study team member respond in a timely manner with clear instructions and/or clarifications. I cannot tell you the number of times I have heard from site staff that ‘no one is getting back to me’. They have been provided with instructions of whom to call but those people may be travelling or cannot make a decision and days can pass while an issue or a question is being escalated internally, if in fact that is occurring. Guess what? The coordinator will focus on the study where the Project Manager always calls him/her back by EOB. This critical period can make or break a relationship. If questions are being answered by multiple parties, are the answers consistent? Is there an FAQ document? Is it being kept up to date? It is the research coordinators on the ground who are actively screening potential subjects, reviewing the consent with them and collecting the data. They are critical to the success of the study when it comes to clean data and subject safety. Be responsive, buy them lunch or a coffee occasionally. Show your appreciation for what they do.

5. Communication with subjects

They have volunteered their time and we would like to retain them in the study for the duration of the trial. For some, a study visit may be the only time that someone listens to all their complaints and spends time with them. We want their trial participation experience to be a positive experience, so they sign up for the next trial and tell their friends about it. Keep them informed about the study progress and let them know the outcome of the trial. Remember their birthdays. Be happy to see them. Make them feel special. They are!

Communications is more than the exchange of information back and forth on various platforms. The end goal for all of us in the clinical trial process is the successful conclusion of the study and ultimately the approval of a drug or device that benefits us all. To achieve that goal, we need to collaborate with each other, patients, researchers and service providers, and have meaningful exchanges. You may not remember exactly what someone said but you will remember how they made you feel and that, in turn, will dictate behaviour. Think about what you need to communicate, who your audience is and how best to deliver the message. Words matter as does context!