A clinical trial is a research study, where a new drug or treatment is tested on people to assess its benefits and risks.
A trial will try to find out:
People choose to take part in clinical trials because this research helps doctors understand more about a disease or condition, which may benefit them or others like them in the future.
In the UK, research and clinical trials are part of the NHS’s work. The people who do research are often the same doctors and other health professionals who provide treatment. This research will often take place in hospitals or clinics. Research also takes place in universities and research institutes, in social care services, or in the private sector (such as by a pharmaceutical company).
There are legal requirements on how a trial should be run. An organisation called the Medicines and Healthcare products Regulatory Agency (MHRA) needs to review and approve every trial, which must also be approved by local ethics committees.
There are different types of trials, depending on the research methods used, and different stages, or ‘phases’, depending how far research has got into a new treatment or drug.
All trials have what is called a protocol. This sets out the trial's aims and objectives. Trials also have rules about who can and cannot join. These are called inclusion and exclusion criteria. Often, for example, women who are pregnant or who want to become pregnant cannot join a clinical trial.
You can find more information on clinical trials, and on making the decision whether or not to join one, on the NHS Choices website and in Understanding Clinical Trials. The UK Clinical Research Collaboration can also provide you with more information about taking part in a clinical trial.
Clinical trials for people with HIV currently taking place are looking at six key areas of HIV treatment and prevention:
Major advances in HIV therapy have been made as the result of clinical trials. For example, we know more about choosing anti-HIV drugs and how and when treatment should be taken from the findings of trials:
Clinical trials have also shown how to best manage other conditions that are common in patients with HIV, such as hepatitis.
Research is also looking at ways of preventing sexual HIV transmission, through the use of anti-HIV drugs as pre-exposure prophylaxis (PrEP) and in microbicides. The HPTN 052 study showed that being on effective HIV treatment makes it 96% less likely someone will pass HIV on to their sexual partner.
Staff at your clinic may know about trials that are being carried out. You could ask your doctor or nurse about any research happening that might be appropriate for you to join.
There are also several registers, or lists, of trials going on at any time. You could ask at your clinic about how to find these.
UK CAB, an HIV advocacy organisation, also has information on how to find clinical trials and has listings of current trials. If you hear of or read about a trial that interests you, the first step is to talk to the trial's contact person. They should give you some information about the trial.
The staff at the trial centre will usually ask you some questions to check that you meet the basic entry requirements for the trial, and you may have a physical examination and a blood test. After the results of all the tests are available, the trial staff will let you know whether or not you are eligible to take part.
It does not necessarily matter if you are currently receiving treatment at a different clinic or hospital to where the trial is being carried out. But you should be sure to tell your regular doctor if you do join a trial at a different centre. You may also want to discuss whether or not to join a trial with your doctor or another member of your clinic team.
New research cannot lead to reliable findings unless people agree to take part and, by joining a trial, you can contribute to important medical research. But it’s important to think carefully about joining a trial.
You can find out more about recent research into HIV prevention, treatment and care on www.aidsmap.com.
You can find more information on clinical trials, and on making the decision whether or not to join one, at the NHS Choices website and in Understanding Clinical Trials, from the UK Clinical Research Collaboration.
There is no right or wrong time to join a trial. People join trials at different times and for different reasons. It is something that is best decided in close consultation with your healthcare team and it is worth taking plenty of time to think carefully about your treatment options, and to ask questions, before deciding whether joining a trial is the best option for you.
You will also need to consider your own motivation for taking part in a trial, and what you will need to take into account.
You can find more information on clinical trials, and on making the decision whether or not to join one, at UK CAB ; on the NHS Choices website ; and in resources provided by the UK Clinical Research Collaboration.
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by T. Kelaart
Date due for the next review: 30/9/2014
Content Author: S. Corkery, NAM
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Delta Coordinating Committee Delta: a randomised double-blind placebo-controlled trial comparing combinations of zidovudine plus didanosine or zalcitabine with zidovudine alone in HIV-infected individuals. Lancet 348: 283-291, 1996 Hammer S et al. A trial comparing nucleoside monotherapy with combination therapy in HIV-infected adults with CD4 cell counts from 200 - 500 per cubic millimeter. AIDS Clinical Trials Group Study 175 Study Team. N Engl J Med 335: 1081-1090, 1996 Strategies for Management of Antiretroviral Therapy (SMART) Study Group. CD4+ count-guided interruption of antiretroviral treatment. N Engl J Med. 355: 2283-2296, 2006 ACTG 320 trial halted as three-drug arm proves superior. AIDS Patient Care STDS. 1997 Jun;11(3):194. Connor EM et al. Reduction of maternal-infant transmission of human immunodeficiency virus type 1 with zidovudine treatment. N Engl J Med 331: 1173-1180, 1994 Cohen M et al. Antiretroviral treatment to prevent the sexual transmission of HIV-1: results from the HPTN 052 multinational randomized controlled ART. Sixth International AIDS Society Conference on HIV Pathogenesis, Treatment and Prevention, Rome, abstract MOAX0102, 2011. View abstract on conference website here: http://pag.ias2011.org/abstracts.aspx?aid=4735
NHS Choices website at http://www.nhs.uk/Conditions/Clinical-trials/Pages/Takingpart.aspx
UK Clinical Research Collaboration http://www.ukcrc.org/patientsandpublic/awareness/info/
MHRA website – guidance on clinical trials for medicinal products: http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/index.htm
NIHR: Understanding clinical trials: http://www.crncc.nihr.ac.uk/NR/rdonlyres/05551C09-441F-4C16-B180-8B39F3E62612/0/UnderstandingClinicalTrialsBookletcrystalmark.pdf
UK CAB http://www.ukcab.net/resources/clinical-trials/trial-right-for-me/
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