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Clinical trials are part of the development process for most medicines, but some contest them. This article explores what they are, why they’re conducted, and the main pros and cons of their use.
What are clinical trials?
A clinical trial tests a new treatment for human use. This could be a drug, device, or mental or physical therapy.
Healthcare professionals administer the treatment to a small group of people. This group, usually made up of healthy volunteers but sometimes including patients too, is then closely monitored by researchers checking for side effects.
The trial begins with small doses. If safe, these are slowly increased until the optimum amount is reached. The new medicine is only given to some of the group: others will take an existing drug or a placebo so that researchers can compare and contrast the effects.
Most clinical trials are conducted blind, with the participants unaware whether they’re taking the new medicine, an existing one, or a placebo.
Why are clinical trials used?
Pros
Clinical trials provide a platform for testing new ideas and treatments safely and securely. This helps to quickly drive the development of drugs, devices, and treatments, ultimately benefitting future patients.
The data gathered in clinical trials helps innovators ensure that their new treatment is safe for use. Being able to showcase evidence to support the science behind the inventions means that these treatments are more likely to be legally approved as licensed medicine.
Cons
The nature of clinical trials means that they pose physical and mental risks for participants.
While researchers keep risks to a minimum, there is always the danger of someone suffering an adverse reaction from the treatment. There’s the potential for exploitation too, especially in trials where there is monetary compensation that could entice vulnerable members of society.
Many who run clinical trials seek legal advice for ethical conduct in healthcare to ensure that they’re doing all they can to safeguard volunteers.
Creating a clinical trial is expensive and time-consuming.
In addition to developing the treatments and possibly paying participants, researchers must find and fund premises suitable for a controlled study, invest in monitoring equipment and analyse enormous amounts of data. They must also run several rounds of trials to be sure of their results.
While researchers aim to select a suitable cross-section of the population for their clinical trials, sometimes there are strict criteria to be met which excludes a significant set of people. Other factors restrict testing too, such as the environment and time.
This can limit the generalisability of trial results, making it hard to prove the universal safety and effectiveness of a newly developed treatment.
