Abstract 553P
Background
Early access provision (EAP) is endorsed by competent authorities to improve patient access to innovative medicinal products (InMPs). Despite efforts made by competent authorities to expedite development, review and approval of InMPs, there may still be lengthy delay before oncology patients can gain access to InMPs. Challenges practicing oncologists face when dealing with EAP, together with limited education and support, may influence access of oncology patients to care.
Methods
EAP protocols for oncology InMPs were identified by a search of the ClinicalTrials.gov and EU Clinical Trials registers. On-line, fully anonymous survey reaching out to more than 3,000 physicians was conducted. Practicing oncologists were questioned about their understanding of EAP, level of experience, knowledge on roles and responsibilities, rationale for decision process, interest for further educational activities and opportunities to improve EAP.
Results
During the period Jan 2015 to March 2021, of oncology trials only 149 (0.4%) and 21 (0.23%) included EAP protocols at ClinicalTrials.gov EudraCT registry respectively. Survey results found 75% of respondents were ‘very comfortable’ or ‘comfortable’ with using EAP, but only 54.5% correctly answered the specific knowledge-based question. EAP experience was limited in 56% of respondents. Two-thirds indicated an average or lower level of understanding about application process and regulatory requirements (65.2% and 66.0%, respectively). Knowledge on data collection and reporting under EAP was lower at 57.8% and 50.5% of respondents, respectively. During COVID-19 pandemic, the majority of respondents highlighted need to improve and adapt EAP with regard to application process (83.8%), InMP supply and logistics (88.4), and safety reporting process (78.0%).
Conclusions
Challenges posed by the EAP process for InMP, together with a lack of education on this topic, might contribute to its under-utilization and influence early access of oncology patients to care. Continuous educational efforts from different stakeholders, specifically duting IMP clinical development stage, are required to better inform and support practicing oncologists dealing with EAP.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
The authors.
Funding
Has not received any funding.
Disclosure
A. Krendyukov: Financial Interests, Personal, Full or part-time Employment: Apogenix AG. S. Singhvi: Financial Interests, Personal, Full or part-time Employment: System Analytic. Y. Green-Morrison: Financial Interests, Personal, Full or part-time Employment: System Analytic. M. Zabransky: Financial Interests, Personal, Full or part-time Employment: Hexal AG.