Placebo-controlled, randomised clinical trials are arguably the most reliable method of determining whether a particular treatment is effective for a particular condition. However, the approach does have both positive and negative aspects for both scientists conducting them and the patients participating in them, and finding out about these are useful for a variety of reasons. Generally, trials are conducted in three phases: firstly, the dosages and possible methods of administrating the medicine are explored, then it’s tested to determine its effectiveness for a condition and finally it is compared with current medications. For physicians and scientists, clinical trials are extremely valuable sources of evidence, but for participants, later-stage trials have marked advantages.
Advantages for participants
Clinical trials can be a life-line for patients who have exhausted the accepted treatment options because they offer new and promising approaches to treatment. The trial will most likely involve a medicine which is currently unavailable to the public, and it may be a more effective treatment with fewer side effects. While you participate in the study, your condition will be continually monitored and you’ll probably receive a greater level of care as a result.
Disadvantages for participants
The experimental nature of clinical trials can be a disadvantage to participants in the study. The medicine you receive may not be effective, you could suffer from an adverse reaction to it or it could have more severe side effects. In randomised and placebo-controlled trials, half of the participants receive the real medicine and half receive a sugar pill, and neither the participants nor the researchers know which participants are receiving which treatment. Later stage trials often involve comparisons to existing medicines, which removes the risk of receiving inactive medicine. You’ll also be subjected to more tests and form-filling than you would with ordinary medical treatments.
Advantages for researchers
There are numerous advantages of clinical trials from the researchers’ perspectives, because they enable a medicine to be directly tested as a treatment for a particular condition. Using a placebo-controlled and randomised approach reduces the risk of the placebo effect, as well as both observer and selection bias. This provides more reliable results, which can then inform future treatments. Clinical trials also further the medical field and can provide much-needed revenue for organisations.
Disadvantages for researchers
Clinical trials are largely advantageous for researchers, but there are some limitations to the approach. If the researchers conducting the trial don’t fully apply the scientific method, and conduct the experiment sloppily, the results could be misleading. For example, a flaw in the methodology relating to the “success” criteria could lead medications to look more or less effective than they actually are. The results of clinical trials are also more general, meaning that they can’t always be directly applied to individual patients. For example, if research shows that a particular drug is effective in 90 percent of patients, one in ten with the condition will get no better or possibly suffer serious adverse reactions.
- Mendosa: Double-blind studies
- JAMA: Limitations of applying summary results of clinical trials to individual patients
- Wiley: Clinical trials: values and limitations
- Physician's Practice: Pros and cons of clinical trials
- Medscape: Clinical trials can boost your bottom line - are they worth it?
- Univeristy of Iowa Hospitals and Clinics: Pros and cons of clinical research
- Cancer Australia: Advantages and disadvantages of being in a clinical trial
- NHS: Clinical trials and medical research