In today’s clinical trial process, we are finally allowed to focus on what truly matters. Dialogue with regulators can also move the process forward—as long as the industry doesn’t make it unnecessarily complex.

Kliinisen tutkimuksen prosessissa saa nyt luvan kanssa keskittyä olennaiseen. Keskustelu viranomaisen kanssa vie eteenpäin myös prosessia, kunhan teollisuus ei itse tee siitä tarpeettoman monimutkaista. Järkevä ajattelu on sallittua.

Istuskelimme vuosia sitten työryhmässä, joka pohti sitä, miten kerätään näkemyksiä. Kielenä oli englanti ja keskustelun kohteena ”insight” – mitä se on ja mitä se ei ole. Suomen sana ”näkemys” on oikeastaan varsin toimiva käännös...

Years ago, I found myself in a working group trying to pin down what we really mean by “insight”—and what it definitely isn’t. An insight is more than a quick opinion or a standalone fact; it’s something that takes shape over time; through experience and an understanding you’ve built step by step. In drug development, that kind of insight is what helps you make decisions and keep a project moving. Opinions and data matter, of course, but on their own, they don’t do the job. When I talk with a clinician who knows a disease area inside out, I come away with a flood of smart ideas and practical perspectives from everyday clinical work. And the real value comes from talking to several specialists, because each brings a different angle that deepens the overall picture. Best would be to get them (also with patients and other experts) in the same room. In a couple of hours, you can generate an impressive amount of sharp, well-processed medical thinking. Still, for the purposes of drug develop