Modified intention to treat reporting in randomised controlled trials: systematic review

“Modified” intent-to-treat population is one of the most common manipulations in (predominantly industry-sponsored) clinical trials. I think a sincere way of getting around loss to follow-up/protocol deviations in randomized controlled trials would be to use dichotomous outcomes (dichotomize, if needed) to estimate relevant measures of treatment effect (e.g., RRR) and likely benefit (e.g., NNT) after attributing all loss to follow-up/nonadherent cases as failures. However, a majority of investigators/statisticians from sponsoring companies would be unwilling to do that, as it would reduce the claimed efficacy of their products. Instead, they choose to exclude patients from the analyses in the name of the intent-to-treat principle, losing the benefits accrued through randomization in the process.