Psychological aftermath of abortion

based on clinical trials or “real world” trials (or both), but under the current policy, patients receiving a prescription for a new drug will be unaware of the full scope of the evidence. If it consists solely of data from randomized clinical trials, then patients ought to be informed that there may be limitations in detecting unmeasured or rare adverse outcomes that might appear later in a real world setting, in observational studies or in additional clinical trials. The proposal by Eike-Henner Kluge that newly released drugs be given conditional licences until the outcomes of phase IV studies are known would ensure that health care professionals inform patients that the prescribed drug is still under review by Health Canada. Patients who decide to take the new drug (after being informed of the benefit–risk balance, the alternative options and their effectiveness, costs and uncertainties) should then be monitored for adverse effects and any such adverse outcomes reported to appropriately designated authorities. From an ethical point of view, there are similarities between patients who participate in randomized controlled studies and those who participate in real world trials, since in both types of studies, drug efficacy and safety are still under review. Therefore, it seems to me that the ethical guidelines currently applied for the first group should also be applied to consumers of medications prescribed under conditional licences.