Protecting patient safety during a clinical trial

 

Introduction

Before a medicine can be authorised for use, it must go through a number of trials (clinical trials) to monitor its effect on groups of people.  The clinical trials are conducted to ensure that the products meet the required quality standards, and produce the effect/s as presented to patients. 

Investigating the effects of medicines

Clinical trials are carried out to collect data on the safety and efficacy of potential new medicines. These trials can be conducted using healthy volunteers or patients, depending on the type of product and its stage of development. Information on the non-clinical safety would have been obtained before the clinical trial programme commences.

Clinical trials begin with small studies in a controlled population of healthy volunteers or patients and, as data is gathered, they are expanded to large scale studies in patients. Anyone participating in a clinical trial must receive both written and oral information about the trial, and participants must give their consent before the trial starts.

Large scale studies will often investigate the new product and the currently used treatments to see how these two compare. As more information is obtained, larger numbers of patients are exposed to the new product and safety data can then be collected giving more information on the safety of the product in the intended patient population. 

Approval of a Clinical Trial

In Malta, clinical trials must be notified to the Licensing Authority (through the Medicines Authority) by the person, individual or group that takes overall responsibility for the trial (the sponsor). A medical doctor or a dentist (the investigator) must always participate in the conduct of the trial. The Medicines Authority evaluates both the quality of the investigation and the patient safety of clinical trials. Clinical trials must also be notified to the health ethics committee, which performs an overall assessment of the trial's ethical aspects. Before a clinical trial can be started, approvals must be obtained from both the health ethics committee and the Licensing Authority. 

Access to Information on authorised Clinical Trials

For access to information on the authorised pharmaceutical clinical trials that are ongoing in Malta, an EU Clinical Trial public register is available here.

The online register gives public access to information on interventional clinical trials for medicines authorised in the 27 EU Member States and Iceland, Liechtenstein and Norway. The database increases transparency of medical research and helps patients and health care professionals to find information about clinical trials taking place in Malta and Europe.

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