As a Research Hospital, the IOV pursues mainly clinical and translational research objectives.
Below are the data, provided by the UOSD Clinical Research Unit (URC), on active clinical trials, patients enrolled and revenues from trial activity.
PREVALENT ACTIVE STUDIES PER YEAR
Total studies | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| year 2021 | 561 | 325 | 145 | 45 | 46 |
| year 2022 | 608 | 333 | 136 | 80 | 59 |
| year 2023 | 622 | 348 | 137 | 82 | 55 |
PERFORMANCE IN TERMS OF PATIENT ENROLLMENT
In addition to activation times, a widely used indicator for evaluating the performance of clinical centers in clinical trials is the number of patients actually enrolled compared to expected.
The table below shows the number of studies that concluded enrollment in the period 2021-2023. Of these, the number of studies with a percentage of patients enrolled greater than 100% and the studies with a percentage lower than 20% of expected are reported. Among the experimental studies, over 61% (100 out of 163) concluded enrollment by reaching or exceeding the target expected for the center, while only 17.8% (29 out of 163) closed with less than 20% of the expected patients.
Patients recruited out of expected (%) | Total studies | Experimental | Observational | Translational | Others |
|---|---|---|---|---|---|
| On total studies | 299 | 163 | 96 | 15 | 25 |
| ≥100% | 176 | 100 | 55 | 7 | 14 |
| ≤20% | 50 | 29 | 15 | 2 | 4 |
PHASE I AND I/II INTERVENTIONAL TRIALS WITH DRUG
Since the end of 2018, a Phase 1 Clinical Trials Center has been active at IOV, certified pursuant to AIFA Determination 809/2015. The Center is divided into two areas: clinical and management. The clinical area is made up of OO.UU. of the medical and surgical area through the respective principal investigators (PI) and co-investigators, the team of research nurses, the UOC Pharmacy and the sample processing laboratory of the UOC Immunology and molecular oncology diagnostics. Support activities for the management of urgencies and emergencies are guaranteed by the Anesthesia and Reanimation Unit. The URC acts as the management area of the Phase 1 Center.
In the oncology field, phase 1 studies are extremely important because they involve the use of new drugs that can represent a unique and valuable alternative for patients without other therapeutic options. These are generally very complex and delicate studies that require considerable organization and an ultra-qualified team.
Below is the number of phase 1, incident and prevalent clinical trials in the three-year period 2021-2023 with the number of patients enrolled per year. An increase can be appreciated both in the number of studies and in the number of patients involved.
New studies | Prevalent studies |
|
|---|---|---|
| year 2021 | 9 | 24 |
| year 2022 | 7 | 25 |
| year 2023 | 10 | 31 |
Patients enrolled | Prevalent patients |
|
|---|---|---|
| year 2021 | 24 | 44 |
| year 2022 | 121 | 161 |
| year 2023 | 120 | 185 |
STUDIES PROMOTED BY THE IOV
The Institute also acts as a non-profit promoter of regional, national and international clinical studies in the oncology field.
Below are the number of new studies promoted by the Institute in the three-year period 2021-2023 and those prevalent in the same period.
Incident | Total studies | Experimental | Observational | Translational | Others |
|---|---|---|---|---|---|
| year 2021 | 32 | 1 | 14 | 7 | 10 |
| year 2022 | 25 | 2 | 15 | 4 | 4 |
| year 2023 | 29 | 1 | 20 | 5 | 3 |
Prevalent | Total studies | Experimental | Observational | Translational | Others |
|---|---|---|---|---|---|
| year 2021 | 101 | 11 | 46 | 29 | 15 |
| year 2022 | 104 | 9 | 41 | 36 | 18 |
| year 2023 | 114 | 7 | 50 | 39 | 18 |
It should be noted that the URC also manages some experimental studies promoted by the Department of Oncological, Surgical and Gastroenterological Sciences of the University of Padua which includes university researchers in agreement with IOV and who act as Principal Investigators for these studies.
PATIENTS INVOLVED IN THE TRIALS ACTIVATED AT THE IOV
The following tables show, for the period 2021-2023, the number of patients involved in clinical trials, divided into:
- incident patients, i.e. those who signed the informed consent to participate in the study in the reference year;
- prevalent patients, i.e. those who are undergoing treatment and/or follow-up in the reference year.
The total number of patients involved in clinical trials has decreased slightly in the three-year period considered, in particular with regard to patients screened for experimental studies. As regards experimental drug trials, the number of patients enrolled increased slightly after the slight decline found in 2022 and after the notable increase found in 2021 compared to 2020. The increase in the number of patients enrolled in drug trials was notable profit type. The increase is also reflected in the number of prevalent patients which increased in 2023.
NEW PATIENTS INVOLVED PER YEAR (SCREENED-INCIDENTS)
Total patients | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| year 2021 | 2.516 | 1.616 | 372 | 148 | 380 |
| year 2022 | 2.675 | 1.092 | 759 | 371 | 453 |
| year 2023 | 1.979 | 852 | 593 | 410 | 124 |
Experimental trials with drug | Screened patients | Patients enrolled |
|---|---|---|
| year 2021 | 1.516 | 465 |
| year 2022 | 1.070 | 450 |
| year 2023 | 819 | 472 |
Total | of whom non-profit | of whom profit |
||||
screened | enrolled | screened | enrolled | screened | enrolled |
|
| year 2021 | 2.516 | 1.463 | 1.222 | 1.180 | 1.294 | 283 |
| year 2022 | 2.675 | 2.019 | 1.893 | 1.763 | 782 | 256 |
| year 2023 | 1.979 | 1.557 | 1.394 | 1.208 | 585 | 349 |
PREVALENT PATIENTS IN TREATMENT PER YEAR (PRE-SCREENINGS AND SCREENING FAILURES EXCLUDED)
Total studies | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| year 2021 | 3.780 | 1.672 | 970 | 834 | 304 |
| year 2022 | 4.332 | 1.799 | 1.005 | 910 | 618 |
| year 2023 | 3.896 | 1.842 | 770 | 888 | 396 |
Total patients | non- profit | profit |
|
|---|---|---|---|
| year 2021 | 3.780 | 2.773 | 1.007 |
| year 2022 | 4.332 | 3.304 | 1.028 |
| year 2023 | 3.896 | 2.796 | 1.100 |
Total experimental patients with drug | of whom non-profit | of whom profit |
|
|---|---|---|---|
| year 2021 | 1.623 | 683 | 940 |
| year 2022 | 1.746 | 776 | 973 |
| year 2023 | 1.785 | 725 | 1.060 |
REVENUES FROM CLINICAL TRIAL ACTIVITIES BY TYPE OF FUND
The proceeds from clinical trial activities are linked to various items including:
- the fee that profit promoters pay for the opinion of the ethics committee (CESC-IOV);
- the amount foreseen for the administrative monitoring of studies by the URC;
- reimbursements for the performance of services and visits in the context of clinical trials and the fee per enrolled patient.
In the overall evaluation of the proceeds, the savings in pharmaceutical expenditure linked to the inclusion of patients in studies that provide free oncology drugs should also be considered.
Below is the data provided to you by the Fund Management Office of the UOC Human Resources.
CESC’s share | URC’s share | IOV’s revenues | Total |
|
|---|---|---|---|---|
| year 2021 | 598.446,00 € | 179.600,00 € | 6.894.364,00 € | 7.672.410,00 € |
| year 2022 | 547.068,00 € | 189.000,00 € | 7.748.064,00 € | 8.484.132,00 € |
| year 2023 | 159.493,60 € | 30.002,40 € | 7.836.794,50 € | 8.026.290,50 € |