Clinical Trials: Common Questions Answered

1. What are the considerations for patients looking to take part in a clinical trial?

People who choose to take part in clinical trials are protected in many different ways.16

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.4

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 ethicality of a trial.16

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.

2. Is it possible to experience side effects during a clinical trial?

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 with the standard of care.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.17 Clinical trials can only proceed if the safety profile of the investigational treatment is accepted by health authorities and ethics committees.

The healthcare professionals (HCPs) within the research team ensure that patients are fully apprised of possible side effects before they agree to take part in any clinical trial.17 These could range from pre-empted, mild side effects that the research team may expect, or they could be more unexpected. Either-way, the treating HCP would keep a close eye on all trial patients and treat any emerging side effects promptly.3

3. Where do clinical trials take place?

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

4. What are the advantages of being a participant in a clinical trial?

Patients taking part in clinical trials often benefit from a greater degree of clinical oversight and monitoring of their disease by their healthcare team – so more frequent visits and more thorough assessments of their disease status.3

For some patients who are perhaps unable to access alternative treatment options, or where existing medicines have failed to provide benefit, clinical trials can enable earlier access to new, innovative medicines.3

Additionally, supporting clinical trials helps progress scientific understanding of medicine and improves healthcare options for future generations.2

5. How long can a clinical trial last?

The length of a clinical trial varies depending on several factors, such as the type of illness and the type of medicine being researched.18 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. Studies of antibiotics on the other-hand conclude quickly as patients are typically treated on study for a few days only.

6. Do companies such as Novartis pay patients for their involvement in a clinical trial?

It is not common for patients to be paid to participate in a clinical trial, although travel expenses are usually covered.4 In some cases, where the time commitment for a patient is very significant there may be a small fee to compensate for time lost at work for example.

7. If the treatment appears to be helping a patient during a clinical study, can they continue taking the medicine after the trial has finished?

The treatment of patients coming off a clinical trial is at the discretion of their healthcare professional.

Once a clinical trial has finished, patients who have participated in the study may be able to continue taking the medicine for a period of time if it has provided a benefit. In these cases the patient would also continue to attend follow-up appointments with the healthcare professionals managing the study.

8. How can people join a clinical trial?

If you or someone you know is thinking about taking part in a clinical trial, visit https://www.ukctg.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, it is also advisable to consult directly with a doctor before committing to a study.

References
  1. NHS National Institute for Health Research. Understanding clinical trials. Available at: http://c.ymcdn.com/sites/www.ukcrc-ctu.org.uk/resource/resmgr/2)_understanding_clinical_tr.pdf. Last accessed May 2019
  2. Sarah Cannon Research Institute. Clinical Trials FAQs. Available at: http://sarahcannonresearch.co.uk/for-patients/clinical-trials-faqs/. Last accessed May 2019.
  3. Macmillan. Benefits and risks of taking part in a trial. Available at: http://www.macmillan.org.uk/information-and-support/treating/clinical-trials/can-and-should-i-take-part/benefits-and-risks.html#3657. Last accessed May 2019.
  4. NHS Choices. Clinical trials. Available at: http://www.nhs.uk/conditions/Clinical-trials/Pages/Introduction.aspx. Last accessed May 2019.
  5. ECMC. What are clinical trials? http://www.ecmcnetwork.org.uk/what-are-clinical-trials. Last accessed May 2019.
  6. Cancer Research UK. Phases of clinical trials Available at: http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-.... Last accessed May 2019. 
  7. Novartis UK Data on File 033. 2019
  8. Novartis UK Data on File 002. 2019
  9. Novartis UK Data on File 014. 2019
  10. Novartis UK Data on File 038. 2019 
  11. Novartis: Partnering for better patient outcomes. 2015
  12. ABPI. Developing new medicines. Available at: https://www.abpi.org.uk/what-we-do/research-medical-and-innovation/our-w.... Last accessed May 2019.
  13.  Novartis UK. World Sight Day 2016. Available at: https://www.novartis.co.uk/stories/education-awareness/world-sight-day-2016. Last accessed May 2019.
  14. Overview. Chronic Myeloid Leukaemia. Available at: https://www.nhs.uk/conditions/chronic-myeloid-leukaemia/. Last accessed May 2019.
  15. Consentyx Combined: Summary of Product Characteristics. 2018
  16. Cancer Research UK. Safety in clinical trials. Available at: http://www.cancerresearchuk.org/about-cancer/find-a-clinical-trial/what-you-should-be-told-about-a-clinical-trial/safety-in-clinical-trials. Last accessed May 2019.
  17. Cancer Research UK. Advantages and drawbacks 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 May 2019.
  18.  Cancer Research UK. How long does it take for a new drug 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#hWZC0hhpw1mjbXxj.99. Last accessed May 2019.

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