Most communications regarding pharmaceuticals report data as if treating a patient with the mean/median characteristics of a study population represents the day-to-day reality for healthcare providers.
But every patient presents with a unique set of characteristics. Data from phase 1 studies can play a key role in explaining the efficacy and safety of pharmaceuticals and why outcomes may vary between patients. Individual patient characteristics, such as hepatic and renal impairment, age and body mass index, can all influence the degree of exposure to a drug and its therapeutic index (ie, the dose at which a drug is effective versus potentially toxic). Currently, much of this information is not readily available for healthcare providers to consider.
Understanding the pharmacology
The mention of pharmacokinetics, pharmacodynamics and population modelling are generally met with yawns. Pharmacologic data may be considered boring, of interest to few, and of limited practical significance in the clinic. However, at First In Human, we believe understanding the pharmacology underpins effective communication of the benefits and risks associated with medications.
Our team includes specialist medical writers trained in pharmacology and toxicology who can help contextualise phase 1 data within a communications plan, incorporating necessary detail while engaging a broad audience. No good story starts with the hero hiding in an impenetrable fortress refusing to come out!
How do phase 1 studies fit within a story about treatment?
Every good origin story outlines the trials and tribulations that our hero faces on his path to success. No hero story starts with a skilled protagonist slaying a beast.
Phase 1 studies can demonstrate how and why dosing is chosen. For example:
- The absence of dose-limiting toxicities can support claims of safety and tolerability
- Pharmacokinetic studies can help identify potential patient characteristics that could affect efficacy and safety
- Pharmacodynamic studies can underpin claims relating to the mechanistic basis of a drug’s efficacy.
Authenticity is key
A skilled storyteller brings a tale to life, by knowing what to emphasise, and how, drawing the audience’s attention to the key points and adapting the story as needed. Therefore, it is important to engage medical communications suppliers who can effectively and efficiently translate the jargon used in technical pharmacology reports into a format where the clinical implications of early-stage studies can be readily understood and applied by healthcare providers.
Stories do not need to be told sequentially to be effective
While communicating data often follows a logical, linear flow, stories can be punctuated by flashbacks that fill gaps in background knowledge because you must know where you have come from to understand where you are going. Accordingly, a reservoir of underutilised and undervalued early-stage data remains unpublished because its true value has not been realised.
As a drug development story evolves, details of pharmacokinetic and pharmacodynamic effects can provide justification and insight into potential new and expanded indications, while also strengthening the foundation that supports an established indication.
Where can we tell our story?
The perception of preclinical and phase 1 data only being suitable for publication in a narrow selection of specialist translational medicine and clinical pharmacology journals is becoming outdated.
Clinical journals with a broader readership are increasingly interested in publishing results from phase 1 studies to meet the demand for deeper insight into the characteristics of new drugs. Likewise, journal editors understand their obligation to support study sponsors as they strive to meet clinical trial reporting guidelines.
Ethical considerations surrounding phase 1 studies
There is also an ethical obligation to publish data from all studies conducted in humans. The current approach of disproportionately publishing data in phase 2 and 3 studies risks creating two tiers of study participants, prioritising those that participate in a study with a therapeutic aim over those who voluntarily risk their health in first-in-human studies.
However, all study participants should have an equal expectation that their contribution will enter the publicly available scientific body of knowledge.
Utilising your origin story
Publishing phase 1 data unlocks your drug’s origin story, adding a crucial layer of detail that informs how treatment theory became treatment reality.
Integrating pharmacokinetic and pharmacodynamic information into messaging can help healthcare providers move beyond representative clinical trial patients to understanding how individual characteristics affect the real-world efficacy and safety of a drug while building trust and transparency in the pharmaceutical industry. All you need now is your knowledgeable sidekick to help you on your journey.
Blair Hesp is Principal Consultant, First In Human and Managing Director of Kainic Medical Communications Ltd
