Clinical Trials Research Unit (CTRU) "Clinical trials talk" - Culture Night - Sept 2021 - Mater ...

Clinical Trials Research Unit (CTRU)
                 “Clinical trials talk”
          Culture Night – Sept 2021

                Follow us on twitter:@matertrials

History of Clinical Trials Research Unit (C.T.R.U.)

   Founded in 2000, in the Mater Campus by Prof John McCaffrey

   Current Clinical Director: Prof Cathy Kelly

   213 studies opened to date (as of August 2021)

   2106 patients recruited to studies (as of August 2021)

C.T.R.U. STAFFING
Role
Clinical Nurse Manager 3 Clinical Trials – Bindu Krishnanivas
C.T.R.U. Business Manager – Lisa Scahill
C.T.R.U. Administrator - Karen Geraghty
C.T.R.U. Data Coordinator - John Heeney
Data Managers (x 5)
- Brian Whelan
- John Dunne
- Orna Harraghy
- Frances Kenny
Study Coordinators/Clinical Nurse Managers 2 ( x 2) C.N.M.1s ( x 4)
- Ciara Clancy
- Siobhan Carey
- Ralph Villamayor
- Valerie Mullen
- Michelle Matthews
- Suzanne O’Neill

Pharmacy, M.M.U.H.– Cliodhna McDonald
Pharmacy, Mater Private Hospital – Isabel Brady

Clinical Trial Sponsors working with
               the Mater

                                 Collaborative
                                 Groups

Study statistics at the Mater
   Total number of studies opened to date: 213

   Open for accrual (trials currently active with patients): 15 studies

   Closed for accrual (trials currently closed for patients): 58 studies

     - Active on treatment (Closed): 8

     - Follow up studies: 30

     - Closed with no participants : 18

   Closed out (Fully completed trials): 139

(Accrual – A medical term meaning the number of patients who are in
any given trial)

Total Accrual 2011 to 2021 at the Mater -
         Number of patients who took part in
                   studies each year
300

             250
250
                    232

200                               190

150
                           135

                                                              104
100                                                                  88
      80                                                                    83
                                         73
                                                61

50
                                                       33

 0
      2011   2012   2013   2014   2015   2016   2017   2018   2019   2020   2021

ACCRUAL 2019 at the Mater
**TOP IN THE COUNTRY**
Oncology = 99 (Participants in Trials)
Year of Enrolment                                        2019
Month of Enrolment                                       (All)

List of Clinical Trials at the Mater                     Total Number of Patients at
                                                         Start
CLEE011O12301C (TRIO033) NATALEE                         2
CTRIAL 16-60 - CLL 13_Trial Leukaemia                    2
CTRIAL -IE 17-15 BIG 16-05/Impassion 030                 3
CTRIAL-IE 11-29 ICON 8 B                                 6
CTRIAL-IE 16-19 Add ASPIRIN                              8
CTRIAL-IE 18-01_t-BRCA                                   36
CTRIAL-IE_TBC ENGOT-cx8 GCT1015-05                       1
NON CTRIAL-IE 775-00/E7080-G000-309                      3
NON CTRIAL-IE CO-338-052 Clovis Oncology, Inc TRITON 2   1
NON CTRIAL-IE CO-338-063 Clovis Oncology, Inc TRITON 3   1
NON CTRIAL-IE LYMRIT 37-01                               1
Non CTRIAL-IE TNBC Research Project with UCD             1
PUMA-NER-9501                                            37
Grand Total                                              102

What is a Clinical Trial?
   The patient is at the forefront of every trial!
   A clinical trial is a research study in humans with the aim of answering specific
    questions about a new medical treatment.
   They are used to determine whether new drugs are both safe and effective.
   The aim of clinical trials is to find answers for curing the disease if possible,
    prolonging life, ensuring quality of life and to understand a persons’ cancer
    more.
   Clinical trials are conducted in accordance with very strict EU regulations
    known as I.C.H. G.C.P. guidelines- Declaration of Helsinki 1964.
   They are monitored and audited regularly.

Phases of Clinical Trials

Phase                     Phase                     Phase                    Phase
  1     Tests safety of
                            2     Tests drug in a     3     Tests the          4
                                  larger group of           effect and
        drug doses                                                                   FDA approval
                                  people                    safety of drug

        Records side              Measure                   Measures                 Post marketing
        effects of drug           effects                   benefit

                                                            New drug is
        Has a small
                                  Tests safety              compared to
        number of
                                  and drug doses            standard or
        patients
                                                            placebo drugs

        Comes from
                                                            Longer follow
        preclinical
                                                            up on patients
        trials

        Can focus on
        rarer cancers

Informed Consent
   This is voluntary and completely up to the patient.
   It will not affect a patients standard treatment in any way if a patient
    decides not to partake in a trial
   Patients need time to decide if they want to participate so that they
    can make an informed decision.
   If a patient decides to participate, compliance or following the
    guidelines of the trial is really important. Non-compliance can effect
    trial outcomes.
   We don’t know beforehand if the trial will benefit a patient but there
    will be strong evidence to support the possibility of a benefit.

How do we know clinical trials are safe ?
 •   There are laws and regulations which say how trials must be carried out.

 •   Every clinical trial must be approved by the Health Products Regulatory
     Authority (HPRA) and a recognised ethics committee.

 •   Researchers must provide all information about the trial, how it will be
     carried out and all the scientific and medical information. HPRA will make
     sure it meets Irish, EU and international standards.

 •   Patient safety and wellbeing are looked after by the ethics committee.

 •   There are regular inspections.

What's it like to be on a trial ?
   Screening to take part can be intense

   Patients may not meet the criteria for the trial after screening is
    complete and will not be able to participate

   The treatment phase requires more monitoring than usual which
    patients can find reassuring

   Patients may have to have extra bloods drawn which are for research
    purposes

   Patients will be followed-up for a number of years

Trial-Specific Terms
   Randomisation
Random selection of a study arm by an online database. We have no control of what
arm you will get, it is down to chance. This is to avoid bias and ensuring a balance
between arms.
 Blinding
This means whoever is assessing the patient and the effects of treatment will not
know which type the patient is getting: the tested drug or placebo.
There are different types :
Single blind – The patients in the study do not know whether they’re receiving the
real treatment or the placebo but the observers do.
Double blind – Neither the observer or the patient know which treatment they’re
receiving; this type of study produces the best results as it is the least biased.
 Open label
Everyone knows what the patient is getting.
 Placebo
A treatment that does not contain any active substance (essentially a fake version of
the test drug).

Screening

           Randomisation

                            Control Arm
Investigation Arm    Placebo or Standard of Care

         Treatment Phase

         Follow-up Phase

Positive outcomes

Breast Cancer
                                             Herceptin
    The drug Herceptin was developed in the 1980s and this drug targets the HER2 mutation.
 The development of Herceptin has been found to greatly improve patients' outcomes with HER2+
                                        breast cancer
                             This was discovered through clinical trials

                                           Oncotype Dx
Oncotype Dx looks at different genes in your cancer and predicts how likely it is that your cancer is
                                 going to respond to treatment.
 It’s used in two ways; One, to help doctors figure out a persons’ risk of early-stage breast cancer
  coming back in a different part of the body. Two, to help figure out if a person will benefit from
                                           chemotherapy.

Melanoma (Skin Cancer)
                                     CheckMate 067
     A combination of immunotherapies, Nivolumab combined with Ipilumumab have
transformed the treatment of metastatic melanoma (skin cancer that has spread to other
                                 parts of the body).
Treatment of melanoma with these agents has notably improved the survival outcomes.
    The trial was conducted globally, including in the Mater Misericordiae University
 Hospital/Mater Private Hospital, and showed a significant improvement in response to
 treatment, a progression-free survival and overall greater survival using the combined
                       treatment of Nivolumab plus Ipilimumab.

                                     52% with Nivolumab
                                      plus Ipilumumab

                             44%                          26% with
                          with Ipi                          Nivo
                           alone                           alone

Current Trials at The Mater

Thanks for reading
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