As a Research Hospital, the IOV pursues mainly clinical and translational research objectives. Below are the data on active clinical trials, patients enrolled and revenues from trial activity in the three-year period 2021-2023 or in any case updated to the latest consolidated data available.
NEW STUDIES BY YEAR OF ACTIVATION
The table below represents the number of incident/activated studies per year and, therefore, those for which, having completed the evaluation-authorization process, the center is activated and patients are enrolled.
It should be noted that during the two-year period 2022-2023, the reference legislation for clinical trials underwent a radical update. Therefore, the implementation of new rules, operating methods and IT platforms has changed the submission, evaluation and authorization process, involving all interested interlocutors (promoters and participating centres). This, inevitably, resulted in a partial reduction in new studies activated. This, inevitably, resulted in a partial reduction in new studies activated.
Total studies | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| 2021 | 168 | 89 | 51 | 11 | 17 |
| 2022 | 134 | 57 | 46 | 19 | 12 |
| 2023 | 123 | 63 | 42 | 7 | 11 |
PREVALENT ACTIVE STUDIES PER YEAR
The table below represents the number of prevalent studies per year and, therefore, those conducted during the indicated year, both with active enrollment and with patients in treatment or follow-up.
Total studies | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| 2021 | 561 | 325 | 145 | 45 | 46 |
| 2022 | 608 | 333 | 136 | 80 | 59 |
| 2023 | 621 | 347 | 135 | 82 | 57 |
PREVALENT PATIENTS IN TREATMENT PER YEAR
The following table shows, for the three-year period 2021-2023, the prevalent number of patients (who are undergoing treatment and/or follow-up in the reference year as part of a clinical trial) with the details of the patients enrolled in experimental studies with drug.
Total studies | Experimental | Observational | Translational | Others | Patients in experimental studies with drugs |
|
|---|---|---|---|---|---|---|
| 2021 | 3.780 | 1.672 | 970 | 834 | 304 | 3.780 |
| 2022 | 4.332 | 1.799 | 1.005 | 910 | 618 | 4.332 |
| 2023 | 3.837 | 1.837 | 718 | 879 | 403 | 3.837 |
PATIENTS RECRUITED OUT OF EXPECTED (%)
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% (92 out of 150) concluded enrollment by reaching or exceeding the target expected for the center, while only 18.7% (28 out of 150) closed with less than 20% of the expected patients.
Total studies | Experimental | Observational | Translational | Others |
|
|---|---|---|---|---|---|
| Su totale studi | 284 | 150 | 94 | 15 | 25 |
| ≥100% | 168 | 92 | 55 | 2 | 3 |
| ≤20% | 48 | 28 | 14 | 2 | 4 |
PHASE 1 TRIALS
Since the end of 2018, a Phase 1 Clinical Trials Center has been active at IOV, certified pursuant to AIFA Determination 809/2015. 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.
New studies | Prevalent studies |
|
|---|---|---|
| 2021 | 9 | 24 |
| 2022 | 7 | 25 |
| 2023 | 10 | 31 |
Patients enrolled | Prevalent patients |
|
|---|---|---|
| 2021 | 24 | 44 |
| 2022 | 121 | 161 |
| 2023 | 120 | 185 |
REVENUES FROM CLINICAL TRIAL ACTIVITIES BY TYPE OF FUND
During the two-year period 2022-2023 there was full application of EU Regulation 536/2014 on clinical trials, according to which the evaluation of interventional studies with drugs to be conducted at the IOV is carried out by a single territorial / national ethics committee, different from the IOV Ethics Committee (CESC). In addition, with D.M. 01.26.2023, the ethics committees in Italy were reorganized with the identification of 40 Territorial Ethics Committees (hereinafter CET). With DGR n. 330 of 03.29., 3 CETs have been established 2023 in the Veneto Region and among these the CET for the Northern area of the Veneto Region based at the IOV.
The reduction of the CESC quota, now CET, and consequently of the URC quota (as required by rgw IOV regulation), is due to a reduction in the number of studies evaluated by the CESC itself during the year 2023. For the aforementioned reasons, the ethical-scientific evaluation activity of the three-year period 2020-2022 is not comparable with that of the year 2023. However, the revenues from the studies have not changed.
CESC’s share | URC’s share | IOV’s revenues | Total |
|
|---|---|---|---|---|
| 2020 | 507.086 € | 80.200 € | 7.225.556 € | 7.812.842 € |
| 2021 | 598.446 € | 179.600 € | 6.894.364 € | 7.672.410 € |
| 2022 | 547.068 € | 189.000 € | 7.748.064 € | 8.484.132 € |
| 2023* | 89.247 € (CESC/CET) | 38.249 € | 8.082.944 € | 8.210.440 € |
* not consolidated data