After trail inclusion
As soon as a patient has been successfully included into one of the GHSG’s trials, the respective therapy, which is specified in the trial protocol, can begin. The course of your treatment, including tumor response to treatment, side-effects and the results of follow-up examinations, will be documented by your doctor in your regular medical file and, in addition to that, all the details will be recorded on special documentation forms. These documentation forms will be sent to the Trial Coordination Center in Cologne, where they will be checked and stored together with your other data. In order to ensure that the data submitted to the GHSG are consistent with the data documented in a patient’s file, the GHSG employs so-called “clinical trial monitors”. These are people who randomly check whether all essential points have been documented correctly.
The GHSG also offers a telephonic consultation service on weekdays, which is available to both medical colleagues and patients, so that problems occurring during Hodgkin lymphoma treatment or aftercare can be discussed and recommendations to solve these problems can be given.
This service is available to all patients and physicians, regardless of whether a patient participates in a GHSG trial or not. However, it is easier for us to give a recommendation if a patient is treated within one of our trials.
The collected data will be scrutinized at regular intervals by means of safety analyses. With these analyses we make sure that major differences in the therapy outcome between different treatment groups can be identified and corresponding measures can be taken if necessary, e.g. a treatment group could be closed.
If this happened, the respective information and recommendations for further treatment would be immediately passed on to all the treating physicians, who would soon after inform their patients.
If the safety analyses do not give reason for concern, more patients will be included in the trial, until a predefined number of participants has been reached. This number of patients to be recruited is calculated by the statistics experts of the GHSG and is also specified in the trial protocol. When the final number of trial participants has been reached, the trial will be closed, which means that no more new patients will be included. However, the closing of the trial doesn’t impact the treatment and follow-up care of patients who have been included in the trial until this point.
The final analysis of a trial is not carried out directly after the trial has been closed but after a certain period of time, which is specified in the trial protocol and may vary depending on what the study is aimed to find out. This extra time is essential in order to prevent premature conclusions and to determine the optimal therapy.
If the final analysis proves a new therapy to be better, e.g. more effective or associated with less side-effects, these findings will be implemented into the treatment of Hodgkin lymphoma patients in the future.