16 Sep Clinical Trial Naming – Changing the Debate
Naming pharmaceutical products is fraught with challenges and stumbling blocks. Global regulatory authorities require drug marketers to ensure drug names minimize prescription error potential, are easy to pronounce, don’t over-promise and aren’t confused with other marketed drug names, among other requirements. In addition, drug names need to work in multiple languages and across multiple global cultures, necessitating extensive screening. Finally, names must clear challenging, expensive and time-consuming legal hurdles to ensure availability and protection.
Needless to say, crafting a relevant, credible and differentiating drug name requires a careful balance of regulatory, linguistic and legal requirements, oftentimes leaving an imbalance with respect to brand meaning, brand communication potential and brand effectiveness. Anyone who’s been through a global drug naming project knows the incredible difficulty in securing an approvable, effective and usable name. In some ways it’s more about what you can’t do than what you can!
Clinical trial naming, on the other hand, offers companies the opportunity to push the creative envelope much further than with pharmaceutical names. Applying the same standards and assessment to trial naming as to pharmaceutical naming is inappropriate and can be counterproductive to your trial. Too often internal teams fall into the drug naming process and mentality for their trial names, rejecting powerful trial name candidates unnecessarily and prohibiting clinical teams from maximizing the potential of strong and effective communication, education and recruitment opportunities.
The primary difference between pharmaceutical naming and trial naming is that there are no centralized governing authorities requiring submission and approval of trial names. Trial naming requires self-regulation and approval by internal regulatory, medical and legal teams.
This should be a good thing!
Freedom from prohibitive guidelines should allow clinical teams to develop ambitious and powerful trial naming, becoming the foundation—along with good visual branding and compelling messaging—for strong and effective patient engagement. Unfortunately, overly conservative internal vetting often leads to squandered potential and suboptimal trial names.
In our experience, this conservatism occurs in one or more of the following three forms:
1. Fear of Overpromising – The first type of response by internal teams is the fear of sending too promising a message. Regulatory team members have commented, “we feel this name is too overpromising or provides too much hope.” Well there is a fine line to this, as trials in general are being conducted with the objective of hope or an approved treatment. Therefore, determine what you can or should communicate without going too far and providing false hope or optimism. What is the goal of the trial? The desired outcomes or endpoints? Be prepared to discuss and even push back and ask why.
Take note, for example, of Regeneron’s current P3 trial in patients hospitalized with COVID-19. Their trial is called the RECOVERY. Will the trial lead to patient recovery? We don’t know yet, but that’s the purpose of the trial. Stick to your guns if you think it is a valid message objective.
2. Fear of Trademark Infringement – the next type of response comes from a legal perspective that the name is too close to a registered trademark. This may be a valid point but if the trademark is in an unrelated therapy area or product type and since the trial name (typically) is not registered, this is also an area open to debate. There is also a lot of precedent in using trial names that are also existing product names.
For example, an ongoing interventional study to Assess Safety and Probable Benefit of the JenaValve Transfemoral Pericardial TAVR System in the Treatment of High Surgical Risk Patients With Symptomatic, Severe Aortic Regurgitation (AR) is called ALIGN-AR. And coexists with iHealth’s Align smart diabetes test kit.
3. Fear of Pushing the Norm – a third response to trial name review comes from the clinical side where many team members find it almost requisite to create a name that is an acronym of the trial title. This is an all too common request from clients who have developed such names in the past and are fearful of stepping outside of their comfort zones and developing names that speak more to higher-order emotive values or goals (for the patient or of the trial).
Acronyms too often are retrofitted in a clumsy manner and lack intuitive placement in their attempts to utilize letters within a title. For example, The Accuracy Trial was awkwardly crafted from the title Assessment By Coronary Computed Tomographic Angiography Of Individuals Undergoing Invasive Coronary Angiography. Simplicity and intuitiveness did not prevail.
When the letters of the trial actually correspond with some or all of the first letters of the trial title, the result is much more palatable (Access: Acute Candesartan Cilexetil Evaluation In Stroke Survivors). But these scenarios are few and far between, with complex and long trial titles.
As discussed above, trial naming is different from drug naming. You have far more freedom in trial naming. You have the opportunity to develop and utilize creative yet responsible naming that serves to attract, educate and inspire patients, caregivers, HCPs and the public alike. In a competitive trial recruitment environment, every advantage should be considered. Set a strategy, identify potential obstacles, finalize your objectives and develop the best name for your trial.
Now, go forth and boldly name your next trial!
For more information on the trial naming process from Six Degrees, click here.