“Dual enrollment is a significant issue that effects all phases of clinical research and is more common than most clinical sites realize.” – Oleksandr Karpenko, CEO, Ganna Oryshych, Quality Manager, OkClinic, Ukraine.
The problem of dual enrollment in clinical trials, according to many industry experts, has been growing during the last 10 years. It has become especially actual in Eastern Europe and Japan. The Ukrainian investigators have faced this problem as well. Each trial subject, while participating in parallel in some trials, can cost millions of dollars to the sponsor(s) and make the loss of the data received. Patient’s participation in two different trials negatively affects the reliability of the results of two trials. In addition, it’s important to know the kind of phase of trial – the most critical dual enrollment for the second and the third phase of clinical trial.
What are the possible reasons of dual enrollment? Some patients are looking for ways to better care and supervision, opportunities to consult a particular specialist. Patient hopes for adequate medical care, and sometimes psychological support from some doctors. Many patients have combined pathology and try to participate in various clinical trials to get free treatment for several diseases. For its part, sponsor often creates the conditions for a dual enrollment. For example, sponsor doesn’t require proven inclusion criteria, doesn’t check the primary traces of patient (questionnaires, etc.).
In our view, the absence of any patient’s responsibility for his involvement in some trials (e.g. administrative fraud), the accessibility of participation in trials, as well as the absence of compulsory health insurance in our country (it is planned to start in 2017), plays a huge negative role. An important negative role in this matter we can see from the lack of a unified electronic database for outpatients in some nosologies, which is only currently being implemented across the network of medical institutions.
Dual enrollment could cause problems on several levels. Firstly, it jeopardizes the integrity of the trial. The subjects can mask the effects of the medicines in order to remain under the supervision of a physician, or can lie about taking medicines and medical history. If the patient participates in some protocols, the data provided to the investigator may cause damage to the entire dataset and become useless. Secondly, the patient may, not suspecting, expose himself to high risk of developing adverse reactions from uncontrolled combination of medicines as well as expose himself to risk connected with the procedures mixed from the trials (e.g. repeated blood sampling). Thirdly, certainly the sponsor’s (sponsors’) extra costs expected on such patients. And, of course, the wasted time of investigator(s), CRO(s) and sponsor(s).
According to many industry experts, there is absolutely no way to prevent dual enrollment. However, in our view, there area some recommendations that can help investigators and sponsors to avoid such a problem.
The main way is to use the detailed communication with the patient. The experienced investigator always during the visit of patient before making inclusion of him in the clinical trial will ask, “Have you participated in any clinical trial before?”. ”Are you participating in any clinical trial now?“ and “ What medicines are you taking now?”. The careful collection of the data on medical history, as well as obtaining copies of medical records, could be a good tool for identifying the risk of dual enrollment.
The observation of the behavior of patient during the primary survey will help doctor-investigator to suspect and identify the possibility of deception on the part of patient.
The biometrics, identity cards, commercial electronic databases used in some countries also serve the prevention of dual enrollment of patients, and they could be used in clinical trials in Ukraine.