1719P - Decentralized clinical trials: Is there a space in Italy?

Background

The need to identify appropriate formulae to decentralize the clinical trials (DCTs) and enabling their implementation outside hospitals became a dramatic priority during COVID-19 pandemic. However, many obscure points remain concerning DCTs, starting from the regulatory definition.

Methods

In June 22, Life Science Innovation shared an anonymous online survey with the Italian Group of Data Manager to investigate how DCTs’ elements were widespread in Italian clinical research centers. The final survey was structured with 14 questions and remained open for 15 days.

Results

The survey was completed by 35 study coordinators, mostly (54.3%, n=19) from public hospitals, with a median work experience of 8 years. Just over half (48.6%, n=17) declared they could count on Electronic Medical Records, while Electronic Case Report Forms were widely (74.2%, n=26) used. Only in 2 cases (5.7%) these tools are integrated. Over 60% of respondents (n=22) declared no experience in conducting DCTs but the vast majority (72.7%, n=16) expressed interest for the future. The lack of interest is mainly (50%) due to the need of specific skills. Analyzing the answers on the specific digital solutions (n=24, multiple answers option), the most used ones, regardless of the pandemic emergency, are devices (eg sensors) for remote parameter collection (60%), tools for collecting patients’ data like apps for monitoring the therapeutic adherence (60%) and for delivering Electronic Patient Reported Outcomes (60%). More than half of the respondents (60%) declare a future interest in the remote informed consent process. On a 1-10 scale (strongly disagree - strongly agree), DCTs are considered not fully useful to increase patient adherence (mean score 6.6) or to reduce research time (5.8) and costs (5.9). Even lower (5.5) the suggestion that DCTs could increase patient involvement. There is a convergent thinking that DCTs can increase the amount of Real-world data collected (7.5) and that they require very specific skills (8) as well as address key data privacy and security (8) issues.

Conclusions

Despite the pandemic experience, the interest in a greater diffusion of studies with a partial or total digital component remains limited and crucial aspects should be addressed regarding Italy’s ability to implement DCTs in short run.

Clinical trial identification

Editorial acknowledgement

Legal entity responsible for the study

Gruppo Italiano Data Manager (GIDM).

Funding

Has not received any funding.

Disclosure

M. Di Maio: Financial Interests, Personal, Advisory Board, Consultancy about clinical trial methodology and clinical trial results interpretation: Novartis; Financial Interests, Personal, Advisory Board, Consultancy about immunotherapy in SCLC: Roche; Financial Interests, Personal, Advisory Board, Consultancy about role and interpretation of patient-reported outcomes and quality of life in clinical trials: Takeda; Financial Interests, Personal, Advisory Board, Advisory board about the role of chemotherapy and hormonal treatment in hormone-sensitive prostate cancer: Janssen; Financial Interests, Personal, Advisory Board, Consultancy about the results obtained with lorlatinib and dacomitinib in advanced non-small cell lung cancer: Pfizer; Financial Interests, Personal, Advisory Board, Consultancy about role of osimertinib as adjuvant treatment of NSCLC: AstraZeneca; Financial Interests, Personal, Invited Speaker, Compensation for a talk and a document about role of patient-reported outcomes in clinical trials and in clinical practice, with a specific focus on lung cancer: Boehringer Ingelheim; Financial Interests, Personal, Advisory Board, Participation in advisory boards about olaparib in pancreatic cancer, about olaparib in prostate cancer, and about immunotherapy in lung cancer: Merck Sharp & Dohme; Financial Interests, Personal, Advisory Board, Consultant for the new indication of avelumab in urothelial cancer: Merck; Financial Interests, Institutional, Research Grant, Financial support and drug supply for the Meet-URO12 trial (niraparib as maintenance treatment of urothelial carcinoma after first-line treatment with platinum-based chemotherapy): Tesaro - GSK; Financial Interests, Institutional, Local PI, Local PI of trial with tislelizumab in hepatocellular carcinoma: Beigene; Financial Interests, Institutional, Local PI, Local PI of a trial with cabozantinib and atezolizumab in advanced HCC: Exelixis; Financial Interests, Institutional, Local PI, Local PI of a trial with atezolizumab and bevacizumab in advanced HCC: Roche; Financial Interests, Institutional, Local PI, Local PI of trials with pembrolizumab in hepatocellular carcinoma: Merck Sharp & Dohme; Financial Interests, Institutional, Local PI, Local PI of a trial with Sasanlimab in NMI bladder cancer: Pfizer. All other authors have declared no conflicts of interest. All authors have declared no conflicts of interest.