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Clinical Research

documentsAs an NHS patient at Cape Cornwall Surgery, you may be approached to participate in a clinical trial.

In this practice we use electronic records, enabling us to perform searches for specific conditions and you may be identified as a potential study candidate by this method. The information always remains on site and is completely confidential

The aim of a clinical trial is to provide evidence to know which treatments work best, without trials this is not possible and remember many treatments that you are receiving will have been tested in clinical trials. This is the only way we can improve the health of the nation.

Clinical Research is a key principal of the NHS and therefore supports and encourages us all to participate, by providing information and answering the questions that you may have to help you decide whether or not to take part in a trial. The following sites may be useful and please click on them to find out more.

Information from the NHS about clinical trials

http://www.library.nhs.uk/trials

Medical Research Council

http://www.mrc.ac.uk/

UK Clinical Research Collaboration

http://www.ukcrc.org/

UK Clinical Research Networks

http://www.ukcrn.org.uk/

National Institute of Health Research

http://www.nihr.ac.uk/

INVOLVE

http://www.invo.org.uk/

Your participation in a clinical trial is going to be greatly appreciated and make a difference, however, should you choose not to after being approached, we apologise in advance and thank you for giving it some consideration.

What are the different phases of clinical trials?

Clinical trials go through 4 different stages from Phase 1 early trials to Phase 111 and 1V which are the phases we mainly participate in.

Phase 1

The first stage and usually involves small groups of healthy people or patients – aimed at finding out how safe a drug is and usually carried out in Phase 1 Clinical Trial Units

Phase 2

Examines how well a new treatment works in a larger group of people, measuring the safety and side effects and if it has a positive effect in patients

Phase 3

Compares new treatments to existing standard treatment – involves hundreds sometimes thousands of patients from all over the UK and globally.

Phase 4

Carried out after a  new drug has been shown to work and has been given a licence, looking more at how well it works when it is used more widely and the long term risks and benefits

You may ask what the benefits of participating in a clinical trial are.

  • You may have a condition or disease that cannot be treated with an existing drug or treatment, participation might provide a successful treatment before it is available.
  • Drugs offered during a trial are often provided at no cost to the participant
  • You may gain a better understanding of your disease or condition as the trial focuses directly on the medical problem being studied
  • During a clinical trial you have regular visits with the Principal Investigator who often needs to review other aspects of your medical health and conditions; this can sometimes highlight the need for further investigations.
  • Sometimes the requirements for clinical trials cover tests that you would not normally be eligible for and you may feel a good MOT is worth having.
  • You may do it for humanitarian reasons and the future or your children.
  • You may also ask what the drawbacks are.
  • In some clinical trials you may not know whether you are receiving the trial drug or a placebo
  • There may be side effects – However, all drugs come with side effects
  • You may be required to spend a few hours at the clinic and attend appointments on a regular basis
  • You may be required to have blood tests/ spirometry or ECG’s at every  clinic visit
  • You may be concerned about privacy and confidentiality of your clinical information

The confidentiality of records that could identify subjects is protected in accordance with the Data Protection Act 1998.

Most Clinical trials require the collection and storage of personal data, so just to reassure you, all identifiable study data such as signed consent forms are stored in a secure place.

Your confidentiality is also ensured by the use of initials and numbers only on research material

Any other documentation that is required to leave the practice is anonymised to remove any subject identifiers

Electronic data is pass word protected and all staff must comply with the PCT data protection policies and undertake training.

 
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