There is a gap in clinical trial communication. In fact, it is a chasm separating those conducting research and those with study expertise.
Considering how hard it is to execute clinical trials today, logic would say that sponsors and CROs should do everything in their power to make it as easy as possible for research staff to ask questions or clarify their interpretation of protocol instruction.
But until now it’s been hard work for investigators and site staff to get in touch with study experts. Depending on the urgency, they may call, email or use some other non-compliant communication app to reach their main point of contact, often a study monitor. This then kicks off either a game of telephone or an email loop, neither of which are designed for expedited answers.
If you’ve ever played the “game of telephone” as a team building exercise, it is interesting how the fidelity of the message degrades as it passes from person to person. What it shows is the farther away from the source, the less accurately information is conveyed.
Generally, it isn’t something malicious – it’s just the nature of how communication flows. For example, if you have limited knowledge on the subject, you may not be equipped to completely and accurately relay the information. Or you might be distracted during the conversation so that you may not capture the entire story. In turn, what you convey downstream is not quite complete.
Email is better served as a channel to inform than it is to resolve time sensitive queries. Depending on the number of forwards and how long it takes for the information to make its way along a chain of people, it could be too late or even outdated by the time it reaches the intended recipient.
Additionally, email can be open to misinterpretation. For example, we may be unintentionally biased in reading what we think the email says, instead of what it actually says. This could lead to a mismatch of the answer sent back that is not actually to the original question. And If further clarification is needed, the whole email thread kicks off again.
When we look at clinical trials, particularly when physicians and research staff need time sensitive answers, the way communication is handled today is akin to the game of telephone or the email loop. Simply put: neither are fit for purpose.
That is why we are introducing Teckro Connect.
Teckro Connect puts the power directly in the hands of research site staff to ask questions of study experts. It sits within our digital engagement suite, so the user can switch from a keyword search to requesting medical advice – all within Teckro. And it is compliant with industry regulations, including 21 CFR Part 11.
Let’s take the example of a doctor who is with a participant and needs an immediate answer related to dose modification. I’ll contrast the “old way” and the new way with Teckro Connect.
Initiating the Conversation
In the old way, the doctor would email or phone the clinical research associate (CRA) who in turn would forward the query on to the medical monitor. Given the best-case scenario, this answer will take several minutes or hours – maybe longer.
With Teckro Connect, the doctor takes out a mobile phone and starts a conversation with a dedicated group of experts who are assigned by the study team. This means the physician has qualified people on the other end of the conversation who are capable of providing immediate guidance. Directing a question to a team will speed time to resolution. The first team member who sees the question can jump in and answer.
Getting the Best Input Possible
In the old way, if the email loop is just between the CRA and the medical monitor, knowledge from other specialists won’t surface because they aren’t part of the email chain. And after all of that waiting, what happens if the physician has a follow up question? The email loop starts all over again.
With Teckro Connect, responses are visible to the entire group so that other experts can add to the conversation. This thread also allows the doctor to ask any further clarifying questions to fully confirm the best decision. In the end when the query is fully answered, the exchange is marked resolved and the conversation can be exported for inclusion as trial reporting documentation.
Simplifying Study Contacts
In the old way, what happens if the original person the CRA tries to reach is out of the office or unavailable? With Teckro Connect, this is irrelevant because the dedicated group is managed so that no one contact is a single point of failure. And if one person is switched out for another specialist due to holiday, reassignment, etc., the communication thread continues on. This means site staff don’t need to maintain an up-to-date list of contacts. One less thing for them to worry about.
Gaining Visibility for Study Teams
In the old way, emails could be shared or exported to be included in reports. But this is a rearview mirror of the exchange, meaning no real action can be taken because of the questions. Rather, the document is simply reflecting that there was a question and how it was answered.
With Teckro Connect, there is so much more intelligence to be gained not just knowing that there was a question but understanding the substance of the question. Additionally, study teams will gain value from spotting trends if the same questions are popping up over and over. It could mean there is a need to clarify something in the study documentation – or it could be an early indication of a safety issue. Either way, knowing when you can still take action is immensely powerful for our sponsors.
We’ve now added real-time guidance with Teckro Connect to our digital engagement platform. Let’s look at how Teckro Connect complements the other capabilities of Teckro:
In our quest to make clinical trials simpler, more accessible and transparent, Teckro Connect is an important addition to our product family. Good communication is the cure to many problems; disconnected communication is the source of much frustration.
You can find out more about Teckro Connect in a few different ways: