Withdrawn Trials

If a study has been withdrawn, it has been halted prematurely. However, patients may withdraw themselves from studies as well. If a subject does withdraw, the investigator must discontinue all research activities involving the patient’s participation. Furthermore, the patient may also be withdrawn from a study by the researchers because they no longer qualify under the established protocol. In addition, the clinical trial site may be withdrawn if researchers feel the continuation of the trial there is not medically or ethically justified or if the resources needed to continue a clinical trial are no longer available there. However, the most complete withdrawal occurs when either an arm or the entire clinical trial is withdrawn. This withdrawal must occur if there is evidence that participants are no longer safe or study objectives can be answered after only partial completion. Withdrawal may also occur if trial participation recruitment is insufficient and carrying out the trial successfully looks doubtful. Researchers must carefully observe all stages of trial progress in order to announce a necessary withdrawal. Furthermore, sponsors and researchers responsible for clinical trials are also obligated to carry out several steps following the withdrawal of a clinical trial. These include immediate notification of all trial sites, as well as all local and federal authorities. Furthermore, a final report must be prepared by the researchers and sponsors, justifying the withdrawal of the trial. When applicable, this report may need to be published as well. References: