Clinical Trials: Common Questions Answered

October 2020 | COR20-C022a

Clinical trials are heavily regulated by health authorities around the world, including the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) who ensure patient privacy is protected and safety is monitored throughout a study.1

Before patients can be enrolled on a clinical trial, investigational medicines are thoroughly researched in laboratories and, in the UK, a medical ethics committee must approve the ethics of conducting the trial.2

In addition, pharmaceutical companies conducting clinical trials are legally bound to comply with strict legislation in order to protect patient safety. Pharmaceutical companies are inspected by Government bodies to ensure compliance to regulations and legislations.

Participants in clinical trials are rigorously and closely monitored throughout the duration of the study, often seeing their doctor more regularly than if they were treated normally by their doctor outside of a clinical trial.3 Although medicines have been thoroughly studied in a laboratory before patient volunteers are invited to participate in a clinical trial, as with all medicines, there is a possibility that side effects may be experienced.4 Clinical trials can only proceed if the safety profile of the investigational treatment is accepted by health authorities and ethics committees and if the potential benefit of the trial outweighs any potential risks.

The healthcare professionals (HCPs) within the research team ensure that patients are fully informed of possible side effects before they agree to take part in any clinical trial, these could range from expected mild side effects or they could be more unexpected.4 Either way, the treating HCP would keep a close eye on all trial patients and treat any emerging side effects promptly.3

Most clinical trials take place in either hospitals or health centres. To be part of a clinical trial, participants may be required to attend regular hospital or GP visits so that their progress on the study can be closely monitored.3

Advantages

Patients taking part in clinical trials often benefit from a greater degree of clinical oversight and monitoring of their disease by their healthcare team.3 Patients may have access to a new treatment that is only available as part of a clinical trial that may work better than the current standard treatment.4 Additionally, supporting clinical trials helps progress scientific understanding of medicine and improves healthcare options for future generations.1,4

Disadvantages

Patients taking part in clinical trials may experience unexpected side effects of a medical treatment that can be unpleasant and, very rarely, life threatening. The medical research team will explain all the known possible risks and side effects to participants so that an informed choice can be made about taking part.3 Participating in a clinical trial can also mean visiting a doctor or hospital more often, which may be inconvenient and costly and should be considered before agreeing to take part in a trial.3,4

The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched. For example, if the study is researching a treatment for a chronic condition, participants’ progress on the trial may be tracked over a relatively long period of time, such as months or even years. Studies of antibiotics, for example, may conclude more quickly as patients are typically treated on the trial for only a few days.5

It depends on the clinical trial and most trials do not offer payment for people to take part but travel expenses may be covered. It’s important to find out about the risks and any inconveniences involved in taking part in a trial before agreeing to participate.1

If you or someone you know is thinking about taking part in a clinical trial, visit https://www.bepartofresearch.nihr.ac.uk. This website offers further guidance about how trials work and can help connect people to researchers running different studies.

For people considering participation in a clinical trial, please consult directly with a doctor before committing to a study.

  1. NHS. Clinical Trials. Available at: https://www.nhs.uk/conditions/clinical-trials/. Last accessed October 2020.
  2. Cancer Research UK. Safety in clinical trials. Available at: https://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/safety-in-clinical-trials. Last Accessed October 2020.
  3. UK Clinical Research Collaboration. Understanding Clinical Trials. Available at: https://www.ukcrc.org/wp-content/uploads/2014/03/iCT_Booklet.pdf. Last accessed October 2020.
  4. Cancer Research UK. The pros and cons of taking part in a clinical trial. Available at: http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/advantages-and-drawbacks. Last accessed October 2020.
  5. Cancer Research UK. How long a new drug takes to go through clinical trials. Available at: http://www.cancerresearchuk.org/about-cancer/cancers-in-general/cancer-questions/how-long-does-it-take-for-a-new-drug-to-go-through-clinical-trials. Last accessed October 2020.

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