The Pros and Cons of Clinical trials

Clinical trials are research studies that are the primary way that researchers find out if a new treatment e.g. new drug, diet or medical device is safe and effective for people. Often, a clinical trial is used to learn if a new treatment is more effective and/or has less harmful side effects than the previous treatment.

When partaking in a clinical trial, you may be able to try a new treatment for a disease before it is available to everyone, as well as be able to play a more active role in your own health care. In addition, you may have a chance to help others get a better treatment for their health problems in the future.

Despite its advantages, there are also a few downsides to clinical trials, for example the new treatment may cause serious side effects. The proposed treatment may not work as well as the standard treatment or even not at all. Also, you may not be part of the experimental group that receives the new treatment, instead, you may get the placebo. Moreover, the clinical treatment could be inconvenience, as medical appointments can be time consuming due to regular journeys to the study site.

To ensure safety to the patients, every clinical investigator is required to monitor and follow the strict guidance, which is put in place to ensure that every participant is safe. Each clinical trial also follows a careful, detailed study protocol, which describes what the researchers will do. The principal researcher is responsible for making sure this plan is carried out correctly. As well as this, there is also an informed consent process which protects the participants. Before joining the trial, the participants are informed of what may happen and what to expect, for example the possible side effects and risks from the new treatment. As part of the informed consent process, patients are able to ask questions about the process too.

Another danger to clinical trials is when the results of clinical trials aren’t made public. The consequences of this could be dangerous, or even fatal. The case of the anti-depressant Paxil is a classic example of this. The drug company, GlaxoSmithKline (GSK) got approval in 1999 for the production of this drug as a treatment of depression in adults, but not adolescents. As a result, Paxil became an off-label prescription, which meant doctors could prescribe the drug to teenagers, but GSK weren’t able to promote the drug to doctors. Criminal and civil complaints were filed against the company as they defied the instructions of the FDA (the Food and Drug Administration) and selectively releasing misleading information about the studies conducted on the drug Paxil (they had consulted a company to write a piece of forged evidence which proved the drug worked better for depression than the standard treatment and dismissed the side effects, which included suicidal thoughts and actions. In 2015, researchers published a second report on the promotion of Paxil’s use on adolescents, which concluded that the drug was ineffective and unsafe, and that there was ‘a lack of access to data from most clinical randomised controlled trials, making it difficult to detect biased reporting’. Following this, a study concluded that from one quarter to one half of clinical trials are either never published, or are published years after the trial has ended. The possible reasons for this delay include the researcher’s lack of interest, as well as the report of negative results.

However, all clinical trials have risks. In fact, any medical procedure or treatment has risks. The risks of clinical trials, especially phase I and phase II of clinical trials are higher as there is more uncertainty of the results. The question is, whether the benefits of the treatment outweigh the risks, and whether you would be willing to take certain risks to help others.