The most important part of getting a new drug from the laboratory to the patient is through the use of clinical trials.
These involve testing the new drug – often in tandem with a placebo – in a closely monitored situation, so any side effects can be picked up straight away and possible problems recognised at once.
In order to ensure patients are not put in any danger and that the process adheres to strict rules and regulations, all clinical trials are fully supervised through all their stages, from planning to completion.
For all trials, a data monitoring committee, or DMC, is set up to examine the trials safety and procedures. The committee asks for reports from those in charge of the trial, usually annually but sometimes more frequently.
While the trial is taking place, the DMC is involved in keeping an eye on how many patients are involved, any side effects, how many patients leave the trial and the trial results. It can bring an end to a trial if any harm comes to the patients involved, or shorten it if the results are so good the benefits need to be shared with more patients.
The Research Ethics Committees
The Research Ethics Committees (RECs) are another level in approving and monitoring clinical trials. According to the NHS, an REC is responsible for safeguarding the safety, rights, dignity and wellbeing of people taking part in research, independently of the research sponsors.
The organisers of trials must inform the REC of any unexpected effects the drug is having. The REC has the power to stop trials early or ask for changes to be made.
Another stage in the testing process is the follow-up of patients. Researchers follow the progress of patients sometimes for years after they have taken part in a trial, to evaluate any long-term effects in addition to the short-term ones.
This part of the process helps researchers discover whether drugs are more effective long-term than other medicines currently in use.
All drugs being used in clinical trials must take part in an FDA 510k clearance submission, through third party review companies such as TPRG.
These processes enable the most effective drugs to be passed on for use by patients more quickly, while ensuring those that are deemed dangerous or ineffective are withdrawn as soon as possible.