Physician-driven solutions adapted to address trial needs from start-up to enrollment completion
- Assessment of protocol by experienced DAVA MDs
- MD-to-MD feasibility interviews with potential sites
SITE ID, RECOMMENDATION, & START UP
- Identification of high caliber sites based on performance and research history
- MD communication with key investigator to assess site’s enrollment potential, research capabilities, patient population, and study staff’s interest in the study
- Recommendation of sites by prioritization and facilitation of site opening process
MEDICAL SITE MOTIVATION
MD-to-MD and CTS-to-research staff calls:
- Ensure continued study awareness and engagement
- Uncover accrual barriers and communicate real time challenges in screening and referral
- Provide customized accrual support
- Update sites on changes to eligibility criteria
- Recognize changing clinical trial landscape at sites
- Identify potential patients for the study
- Communicate importance of patient selection and benefits of follow-up
- Encourage investigators and study staff to consult with DAVA and/or sponsor regarding decisions on patient withdrawal
Accelerated Patient Recruitment & Increased Patient Retention
DAVA Oncology’s medical oncologists will review the study’s protocol and identify key eligibility criteria that will potentially be challenging to the investigators. Afterwards, our medical oncologists will interview key opinion leaders and key community oncologists to assess the validity of those challenges and discuss possible solutions. Additionally, the interview will cover other important questions, such as how the protocol will fit into the current and future treatment landscapes, which regions will have the target patient population, and ongoing or future competing trials.
SITE IDENTIFICATION, RECOMMENDATION, AND START UP
DAVA Oncology’s relationship with clinical trial investigators offers a unique position to identify and recommend high-performing sites for oncology and hematology clinical trials. DAVA uses objective measures of site performance to approach identification. The key to the evaluation process is a personal interview with investigators by one of DAVA’s experienced medical oncologists. During the interview, DAVA evaluates the potential investigator’s level of interest, understanding of the trial’s concept and design, research experience, and availability of eligible patients. Once DAVA fully assesses a study site and is satisfied that all criteria for selection are met, DAVA issues a formal recommendation to the study’s sponsor. Following site approval by the sponsor, DAVA continues our involvement by maintaining open communication with investigators and research staff to motivate an accelerated start-up of the site.
MEDICAL SITE MOTIVATION AND PATIENT RETENTION
Patients recruited to participate in cancer clinical trials are generally informed about the existence of the trial by a participating investigator. The cornerstone of DAVA’s ability to facilitate enrollment in clinical trials is our relationship with clinical trial investigators and research staff. DAVA provides ongoing support to clinical trials through site visits, weekly phone calls, monthly study teleconferences, and email follow-up. During these interactions, our medical oncologists discuss the trial’s status and diagnose barriers to recruitment. DAVA works directly with investigators and research staff to identify strategic actions to overcome these barriers. The relationships DAVA forms through the open communication with investigators and research staff is critical to keeping clinical trial enrollment “top-of-mind” with investigators.