Research Outline Is research for me Share some of my experiences Project develop process and pitfalls Phase III trials Delivering new agents Supporting trials How to S etting up research team and program ID: 1046405
Download Presentation The PPT/PDF document "in Paediatric Palliative Medicine" is the property of its rightful owner. Permission is granted to download and print the materials on this web site for personal, non-commercial use only, and to display it on your personal computer provided you do not modify the materials and that you retain all copyright notices contained in the materials. By downloading content from our website, you accept the terms of this agreement.
1. in Paediatric Palliative MedicineResearch
2. OutlineIs research for me?Share some of my experiencesProject develop process and pitfallsPhase I/II trialsDelivering new agentsSupporting trialsHow to Setting up research team and programTipsYour personal engagement and development in research
3. Why do (or not) researchPersonal and team satisfactionPotential to impact directly on patient careCollaboration beyond NHS, charities and private funders and organisations Local, national and international impact Local, national and international meaningful contribution Time Time TimeEnergy better spent elsewhere?ProcessesRigorous review by external bodiesDeadlines and timeframesCommitmentFundinggetting itMaintaining itFeeding back Creating jobs -responsible for the sustainmentActively engage with researchAvoid at all cost
4. Types of researchEveryman research:‘Audit’Case report and case seriesRetrospective reviewSingle centre prospective observational studyClinical: Randomised controlled trialCross-over and cohort studiesMulti-centre project Quantitative and qualitativeLaboratory based or beloved ‘translational’ research:New agents and drug company work
5. A project
6. Surprise QuestionData analysis
7. Surprise question
8. SYMPTOM ASSESSMENT TOOLTake 5 steps backRecruitment key issue
9. Decision-making on PICUInterviews
10. Phase of Illness projectInternational collaboration
11. Early phase trialsPhase i/ii
12. PHASE I/II/IIThe earliest phase trials -drug is safe and the side effects A later phase trial tests- new treatment is better than existing treatmentThree main phases of clinical trials – phases 1 to 3. (some 0-4 trials)Phase 1 trials determine drug dose safety, what the side effects are, how the body copes with the drug and if the treatment shrinks the cancer Patients are recruited as small cohorts with escalating doses of drug per cohort- a dose escalation study. ‘First in study’ (first patient recruited)Phase 2 trialsLooks at response to go to a larger phase 3 trialPhase 3 compare a completely new treatment with the standard treatmentDifferent doses or ways of giving a standard treatmentPhase 4 trials are done after a drug has been shown to work and has been granted a licence. What the long term risks and benefits areHow well the drug works when it’s used more widely
13. PPC supporting researchRM largest phase I/II program in Europe10-30 trials open and actively recruitingRole of PPCIncreasing PPC and phase I/II trials hand in handUnique challenges:Unknown symptomsDrug interactions and exclusions/inclusions eg DXMImpact of symptom prescribing on investigations eg LFTS.Identifying symptoms that might preclude or lead to trial stoppageGoing on and coming off trialsMeasurable disease and responseDecision-makingGood symptom control can enable recruitment to a trial, remain on trial and in some cases have lead to life prolonging and life sustaining treatment.
14. HOW TO
15. How to set up a research team/program
16. How to get off the ground (Tips)Idea(s)Small projects:Poster/presentations at national/international conferencePublishFundingLarger projects Parents group (end user group)
17. FundingPart of your postTeam to supportSmall grantsTargeted eg headaches -brain tumour charityLarge grantsNIHR approvedInternational Multi-centreLarge numbersProven track recordBusinesses and corporatesMay need to be part of fundraisingPresentations to boards (non-medical)Families Name of childHard for others to donate toPharmaceutical industryEstablished program and teamCost effectivenessProven track record
18. OUR FUNDING
19. User groupEstablish user group for clinical careBereaved parent group (>1yr bereaved)2 yrs on group Parent chairTOFEmail and F2F Meet 2-3 per yearExcellent for Ethics committeesReview of projectsSupport recruitment
20. If I can….you canNo higher degree No prior research job or experienceJobbing consultant since 1st April 2008Research rich environment Established PPC research team 2015Qualitative and Quantitative research programSolo and collaborative projects New agentsEnd user group- 6 yearsServiceResearchFunding sourcesCM Trust The WellesleyIndividual donationsVarious awarded grantsDrug companiesNational involvementFormularyPANG guidelinesNIHR groupAchievements Publishing and presentingInternational prize and recognitionExpert in PPC outcomesEMACochrane reviewInternational collaborationsInvited expert at EAPCEstablished relationship pharmaceutical industryOnly centre to complete phase I trial
21. YOU?
22. You and researchWriting and submitting for :ConferencepublicationJoin projectGet involved in other ways:Join local and national groups contribute to researchChapters or guidanceBe a Peer reviewerWhat training do you need?Your visionConsider a higher degreeConsider further trainingYou and your personal development/ roleSpecific interests and topicsQuantitative and qualitativeWrite and take forward a project through R&D and ethicsGain experience. Learn from the processNOWFUTURE
23. hAPPY RESEARCHING