Satisfactory results of clinical trials are required by both national and European regulatory agencies before the products or procedures can be granted market authorisation and all the conditions of use agreed. The trials are carried out according to strict procedures (protocols) which have been approved by an independent research ethics committee to protect the interests of people taking part.
Before a new medication can enter the market and be available to patients, its safety and efficacy must be tested throughout the phases outlined below. Volunteer patients can take part in the trials of new medications, provided they meet the specific conditions of the individual trial, which may include the current state of their myeloma, recent treatments and their outcome, age, other health conditions etc. Many people with myeloma are keen to participate in trials, because as well as giving access to new treatments before they are widely available, taking part will guarantee a high level of monitoring from the clinical staff running the trial.
Clinical trials are usually carried out in hospitals, and often take many months or years to collect all the results. They could be funded by a public sector research body, a private foundation (e.g. the International Myeloma Foundation) or research- funding organisation (e.g. the Multiple Myeloma Research Foundation or the European Myeloma Network), or by a pharmaceutical company. In the later phases, trials are often carried out simultaneously at a number of different study locations – which gives patients an increased chance to take part.
Clinical trials in the EU are regulated by the requirements of the EU clinical trials regulation, which is designed to ensure that no harm comes to the participants in trials and that the outcomes are scientifically validated. The regulation replaced earlier EU requirements which had to be implemented by national legislation; often leading to different interpretations in the different countries. The intention of the clinical trials regulation was to encourage more clinical trials to be conducted in Europe by reducing the differences between the regulatory requirements of different countries.