DAVA Oncology, LP- Chief Medical Officer and Executive Vice President of Clinical Trial Services will present at the Summit for Clinical Ops Executives (SCOPE) in Miami, Florida
DAVA Oncology, LP will participate in the upcoming SCOPE meeting in Miami Florida on February 7-9, 2012.
SCOPE provides an opportunity to share ideas and collaborate among professionals in the clinical operations field. SCOPE is an overarching event that brings together five conferences, each featuring specific, best-practice case studies and relevant interactive discussions. Major topics include: forecasting, site selection, recruitment, data collection, and project management. Based on data from previous years, SCOPE 2012 will be attended by over 350 participants from 15 unique countries and representing more than 220 organizations.
DAVA Oncology’s, Dr. John Eckardt and Dr. Martin Lee will address SCOPE on Lessons from Cancer Clinical Trials and on the topic Patients for Cancer Trials: Focus on the Physicians!
Complete Article: DAVA Participates in SCOPE Meeting
Presentations: Site Selection Patient Recruitment
IMPACT OF DIRECT PHYSICIAN-TO-PHYSICIAN CONTACT ON ACCELERATING ONCOLOGY CLINICAL TRIAL ACCRUAL IN MULTIPLE TUMOR TYPES
J. R. Eckardt, A. W. DeMaggio, O. Peracha, M. Levonyak, N. Ku; DAVA Oncology, LP, Dallas, TX - June 2011
The development of more effective oncology agents is critically dependent on the completion of clinical trials. Currently, >4000 oncology trials listed on www.clinicaltrials.gov are accruing pts in the United States, but no more than 5% of all adult cancer patients actually participate in a clinical trial during the course of their therapy. This number has changed little since the 1980s, forcing pharmaceutical companies to focus their enrollment initiatives overseas.1 Barriers to participation in clinical studies remain two-fold: patient skepticism and lack of investigator engagement. Patient hesitancy has been associated with discomfort with or not understanding randomization, fear of being a "guinea pig," insurance difficulties, or concerns about cost and convenience.2 These perceptions are exacerbated by a lack of patient understanding on what clinical studies specifically entail: the concepts of blinding, placebo controls, randomization, and clinical realities. It is therefore vital that clinical investigators, those bringing the study to patients, have a strong understanding of their studies, what they entail, and how best to convey their benefit to the patient in an easy to understand manner. Although nurses frequently oversee the formal consent process, patients look to physicians to guide their decision-making, and whether the physician implicitly or explicitly endorses the trial has a strong influence on cancer patients' choices. In fact, of all patients approached with a trial, 75% consented but no more than 20% of patients who were eligible were offered a trial – illustrating that in the vast majority of instances, it is the investigator who is the gatekeeper to successful clinical trial accrual.3
Document: DAVA White Paper - Accrual Enhancement
Clinical Trial Site Engagement and Commitment Through Direct Physician Interaction with Investigators
John Eckardt, MD, Mukta Maan, MBIOT, Laura Rowley, MHSM, Mark Levonyak and Nora Ku, MD - June 2011
The development of more effective oncology therapy is critically dependent on the timely completion of clinical trials. Unfortunately, up to 40% of trials exceed projected timelines, potentially delaying the availability of improved treatment options to pts. Finding the right sites is one of the most crucial steps in the timely completion of a clinical study. The site must be capable of conducting the study with access to the eligible patient population, a thorough understanding and belief in the study rationale, as well as commitment to the study by keeping it ‘top-of-mind’. Engagement of sites with high accrual potential is a key priority for sponsors; however, many of these priority sites may decline to participate or underperform in accrual. Commonly used methods to engage sites include mass communications, such as email and fax, targeting site coordinators and research staff. As clinical investigators (PI) have a significant impact on the site’s decision to participate in a trial, we evaluated a model that focuses on engagement and commitment of these sites through a physician-to-physician approach.
Document: DAVA White Paper - Site Engagement
Impact of Direct Physician to Physician contact on Accelerating Oncology Clinical Trial Accrual
J. R. Eckardt, N. Ku, A.W DeMaggio, M. Reese, M. Levonyak, V. Jain - ASCO 2009
The development of more effective oncology agents is critically dependent on the completion of clinical trials. Currently, >4000 oncology trials listed in www.clinicaltrials.gov are accruing pts in the United States. For faster and less expensive trial completion, industry and government sponsors move their clinical trials to less developed countries…
Document: DAVA Poster ASCO
Impact of Physician to Physician Interactions Utilizing Case-Based Learning Workshops to Accelerate Accrual
J. Eckardt, N. Levonyak, O. Peracha, A. Nemeth, N. Ku, A. DeMaggio, M. Reese, V. Jain - ASH 2009
The vast majority of clinical research documents are rarely read meticulously by the primary investigators. With typical protocols between 90 to 120 pages in length, many investigators utilize abridged, summarized versions of protocols far more often than the protocols themselves. The usage of protocol summaries often results in different interpretations of treatment interventions, procedures and appropriate patients to be enrolled on the clinical trial…
Document: DAVA Poster ASH