BackgroundAn unmet medical need exists for many oncology patients who cannot be treated satisfactorily by available therapeutic options. Early access provision (EAP) is endorsed by competent authorities to improve patient access to innovative medicinal products (InMPs). This paper determined awareness and understanding among practicing physicians of integrated EAP protocols, and of the procedures involved in EAP applications for oncology trials prior to marketing authorization.MethodsAn on-line, fully anonymous survey reaching out to more than 3,258 physicians (including practicing oncologists) was initiated between November 2020 - January 2021. Participants were questioned about their knowledge and understanding of EAP and the decision processes involved, level of experience, interest for further educational activities and opportunities to improve the process, both in general and specifically during the COVID-19 pandemic. The frequency of EAP protocols for oncology InMPs was identified by a search of ClinicalTrials.gov and EU Clinical Trials registers.ResultsSurvey results (75% oncologists) indicated 75% of respondents were ‘very comfortable’ or ‘comfortable’ with using EAP for their patients, but only 54.5% correctly answered the specific knowledge-based question related to the EAP definition. For 56% of respondents, experience with EAP in daily practice was very limited. Two-thirds indicated an average or lower level of understanding about the application process and regulatory requirements involved (65.2% and 66.0%, respectively). Knowledge on data collection and serious adverse event reporting under EAP was lower at 57.8% and 50.5% of respondents, respectively. Awareness of physician responsibilities was high in 59.7% of respondents, but fewer understood roles and responsibilities of manufacturing companies (31.2%). Most indicated they would consider clinical efficacy and safety data from comparative phase III randomized controlled trials as of high importance to support their decision to apply for EAP (93.4% and 86.8%, respectively). During the COVID-19 pandemic, the majority of respondents highlighted the need to improve and adapt EAP with regard to the application process and documentation (83.8%), InMP supply and logistics (88.4), and safety reporting process (78.0%). Of identified oncology trials with a ClinicalTrials.gov protocol, only 149 (0.4%) included EAP, and 23 used the data to receive a marketing authorization during the period Jan 2015 to December 2020. Of oncology trials with a EudraCT protocol, only 21 (0.23%) included EAP, of which 6 were used to receive a conditional or full marketing authorisation over the same period.ConclusionUse of EAP in daily practice remains limited. Challenges posed by the EAP process, together with a lack of education on this topic, might contribute to its under-utilization and influence access of oncology patients to care. Continuous educational efforts from different stakeholders are required to better inform and support practicing oncologists during the EAP application process and regulatory framework follow up. Education should also be provided on EAP roles and responsibilities, monitoring, and potential adaptations when faced with specific challenges, such as the current COVID-19 pandemic.

Background: Phase I trials aim at offering new therapeutic opportunities to pretreated patients (pts) while assessing efficacy/safety. Trial enrolment is a two-step process: first, an investigator evaluates the pts' eligibility, then the pt is screened and undergoes new tests. This warrants that pts meet the protocol's criteria, notably 90day survival. We report reasons of screening (scr) failure in pts who were deemed eligible by investigators and their outcome.

e18507 Background: An unmet medical need exists for many oncology patients who cannot be treated satisfactorily by available therapeutics. Despite notable efforts made by FDA and EMA to expedite development, review and approval of Innovative Medicinal Products (InMPs), there may still be a lengthy delay before oncology patients can gain access to new therapies. Expanded access (EA) in the USA and compassionate use (CU) in the European Union are pathways endorsed to improve patient access to InMPs. Recently reported data from CDER and CBER revealed that applications for EA pathways dealing with patient cohorts remain low, despite high approval rates. The challenges that practicing oncologists may face when dealing with EA or other early access provision (EAP), together with limited education, may influence the access of oncology patients to care. Methods: An on-line, fully anonymous survey reaching out to more than 3,258 practicing physicians was initiated between November 2020- January 2021. Participants were asked questions about their knowledge and understanding of EA/EAP, level of experience, decision process, interest for further educational activities and opportunities to improve process, both in general and specifically during COVID 19 pandemic. Attributes were rated on a 5-point scale. Results: Analysis of first respondents showed that 70% of practicing physicians rated their own understanding and knowledge about EA/EAP as above average (good or very good). However, only 60% of responders answered specific knowledge-based question correctly. At the same time, only 44% of practicing oncologists reported notable experience with EA/EAP in daily practice. The majority of respondents (90%) felt that availability of clinical efficacy data from comparative phase III RCTs would be considered of high importance; other evidence and study types (e.g. clinical safety, PK/PD, preclinical data) were rated substantially lower. The need for further education around better understanding of the processes and regulatory requirements, roles and responsibilities, and data collection was emphasized by 61%, 36% and 30% of respondents, respectively. During current COVID 19 pandemic, majority of respondents highlighted the need to improve and substantially adapt EA with regard to application process and documentation, InMP supply and logistics, and safety reporting process. Conclusions: Results from this survey suggest that challenges posed by the EA process, together with a lack of education, might contribute to the under-utilization of EA/EAP for oncology patients. Continuous educational efforts are required to better inform and support practicing oncologists during the EA application process and regulatory framework. Competent authorities should consider optimization and implementation of digital tools to facilitate EA applications and follow up during the COVID 19 pandemic.