No More Hiding: TARGET Forces Trial-Like Transparency on RWE

Randomised trials remain the gold standard of clinical research. But they are not always possible: patients are scarce, urgency is high, or ethics forbid withholding treatment. In such cases, observational studies are the only option. Target trial emulation (TTE), designing an observational study as if it were a randomised one, has emerged as the method of choice.

Its popularity has surged. Regulators, health-technology assessors and journals are increasingly open to causal inference from real-world data. Yet reporting has been sloppy. Methods are inconsistently described, assumptions go untested and reviewers are left guessing. Even a carefully executed study can be dismissed if its workings are opaque.

A Checklist for Causal Claims

Enter the TARGET Statement, published in JAMA (Cashin et al., 2025). Developed by an international panel of experts, including Miguel Hernán, co-founder of Adigens Health, it offers the first reporting guideline for studies that emulate target trials. Like CONSORT did for randomised trials and STROBE for observational research, TARGET provides a 21-item checklist covering everything from study protocol to interpretation.

The recommendations are simple but demanding.

• Say explicitly that the study is a target trial emulation.

• Specify the trial being emulated: eligibility, assignment, follow-up and estimand.  Then, show how the observational data align.

• Report assumptions, effect estimates and sensitivity checks transparently.

The aim is not to dictate methods, but to make causal claims auditable.

Raising the Bar

This is more than another guideline. It is a marker that TTE has grown up. For regulators and HTA agencies it will become the de facto standard. For sponsors, it raises the burden of proof: no longer is it enough to claim a study “emulates a trial.” The details must be there, laid out for all to see; i.e., eligibility rules, time zero, analytic choices, robustness tests.

The Road Ahead

The TARGET Statement is both a milestone and a warning. It signals that TTE has entered the mainstream, but also that rigor and transparency are now non-negotiable. For companies hoping their real-world evidence will sway regulators or payers, the message is blunt: treat your study like a trial, or risk it being treated like marketing.