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CONDUCTING THE TRIAL AT YOUR SITE Trial protocol code: ISRCTN30952488

A series of randomised controlled N-of 1 trials in patients who have discontinued or are considering discontinuing statin use due to muscle-related symptoms to assess if atorvastatin treatment causes more muscle symptoms than placebo. CONDUCTING THE TRIAL AT YOUR SITE

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CONDUCTING THE TRIAL AT YOUR SITE Trial protocol code: ISRCTN30952488

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  1. A series of randomised controlled N-of 1 trials in patients who have discontinued or are considering discontinuing statin use due to muscle-related symptoms to assess if atorvastatin treatment causes more muscle symptoms than placebo CONDUCTING THE TRIAL AT YOUR SITE Trial protocol code: ISRCTN30952488 Version 1, 17 November 2016

  2. Making the trial a success • Questions to answer before the trial starts • Strong StatinWISE team • Training your StatinWISE team • Managing the trial at your practice • How to ensure ongoing recruitment • Celebrate success

  3. 1. Questions to address before the trial starts • How to create a strong trial team? • How to deal with colleagues who are not supportive of the trial – what are the issues? • Anxieties about putting patients into a research trial – have you given enough information to your staff, including potential risks and benefits? • How to keep recruitment going? • Incentive to recruit – why should your team take on additional trial related work?

  4. Getting your colleagues to support the trial • Create a strong StatinWISEteam;members should be fully informed and enthusiastic about the trial so they can talk about it to others. Plenty of training materials are available – please ensure your team has access to them. • Spread the word; talk about the trial with your colleagues – ideally before it starts – so that as many people as possible know your site is participating. • Promotion;the trial will be most successful if supported by all relevant team members. THE TRIAL BELONGS TO ALL COLLABORATORS. SUCCESS DEPENDS ON EVERY PERSON IN YOUR TEAM.

  5. 2. How to create a strong StatinWISE team? Provide information and training to all team members Identify people to be responsible for specific trial processes – they must be interested in the trial • The CTU is also part of your team • Good communication is essential • Ask for help and advice if needed • Share your successes and difficulties – we may have experience in dealing with them • A strong, dedicated team is essential to making the trial a success • Roles may include • OR Staff at Site may include: • Principal Investigator • Practice Manager • Practice Administrator • Research Nurse • Practice Nurse Nominate someone to be responsible in your absence

  6. Alleviating concerns about the trial • The trial has been approved by relevant ethics committees • It will be easier for your team members to carry out the procedures if they are fully trained • Training materials can be found in the Study File and on the trial website • The genetic study is optional – only the particular variant thought to be involved in pain will be looked for, no other analysis will be conducted. All instructions and materials required for this have been provided to site

  7. Alleviating concerns about the trial Good Clinical Practice (GCP):is an international ethical and scientific quality standard for designing, conducting, recording and reporting trials that involve the participation of human subjects. • StatinWISE trials follows GCP guidelines • Free online training via our LSHTM website: http://open.lshtm.ac.uk/enrol/index.php?id=6 A certificate will be issued upon successful completion • All staff involved should complete prior to the study starting at your practice

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  9. Alleviating concerns about the trial – Trial Specific Training • MANUAL OF OPERATING PROCEDURES (MOP) • Overview of the trial processes for principal investigators (PI), nurses, practice managers, monitors, other people with responsibilities in the trial • Important that all personnel involved are familiar with the sections relevant to their duties • PI needs to be familiar with the complete MOP • PRESENTATIONS • A selection of PowerPoint presentations explaining the trial procedures • SITE INITIATION VISITS • The CTU will organise face to face or remote training to explain the trial and its procedures prior to recruitment starting

  10. 3. Training your StatinWISE team We will provide all relevant training to staff at your site including: • Investigator Site file and training materials • Search list in your practice’s system • DOCMAIL posting system • Blood sample test tubes for optional genetic study • Treatment packs logistics as the CTU will post those tp participants • We can provide a small filling cabinet to store the ISF and materials. Let us know if your site needs one! Remember: the CTU Team are always available to answer any questions throughout the trial

  11. 4. Managing the trial at your practice Ensure your whole team knows: • who is responsible if key team members are not there (e.g. lead research nurse / PI); identify key people; let CTU know • how to assess eligibility • consent procedures • how data should be completed • where Investigator Site File is kept and who is responsible for maintaining it • what to do if trial materials run out • what to do if team members need advice about the trial • what to do if there is an adverse event

  12. 5. How to ensure ongoing recruitment THE CTU WILL HOLD REGULAR MEETINGS WITH THE TEAM AT YOUR SITE TO ENSURE THE StatinWISETRIAL IS ON THE AGENDA • Things we’ll discuss: • Current status of the trial: Ensure all team members are aware of the current status i.e. how many patients recruited nationwide / at your site • Recruitment strategies: Patient searches can be repeated monthly. Personal experiences of the trial  resolution of any problems • Motivation:Encouragement – keep team motivated • Training: Train new staff – refresh team members on trial procedures • Collaboration :This is a collaborative effort and will be most successful if everyone works together • Support: Network Research Nurse support may be available in your area Remember to arrange holiday cover if key members of the team are planning to be away from the site so that randomisation into the trial can continue in their absence.

  13. 6. Celebrating Success • Feedback:all team members should receive feedback about their contribution to the trial • Praise:all team members should be congratulated for their hard work • Incentives:CTU can provide incentives and certificates. Please share these between the team members • Please provide the CTU with names, email addresses and phone numbers of all team members – we would like to thank them personally • The CTU will feature teams in the trial newsletterand the website. Send us a photo of your team and let us know of any trial related news or other achievements that we might like to mention.

  14. StatinWISE aims to: • Answer an important question for • public health • Answer the question for individual • patients • Bring together research and • care • As little work as possible for • GPs Practices

  15. CONTACT US London School of Hygiene & Tropical Medicine Room 180, Keppel Street, London WC1E 7HT Tel +44(0)20 7299 4684 Fax +44(0)20 7299 4663 Email: statinwise@Lshtm.ac.uk

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