Clinical researchers in the UK voted these topics as most in need of research, in order to improve clinical trials: “How to boost recruitment”; “How to keep participants in the trial once they have been recruited”; and “How to choose which outcomes to collect”. Clinical researchers surveyed in low to middle income countries (LMICs), in contrast, ranked “How to choose which outcomes to collect” and “Methods to train research staff” as the most important research methods to understand further. (BioMedCentral)
Some practical advice for clinicians to avoid regulatory scrutiny
The Anti-Kickback Statute (1972) which prohibits clinicians and researchers from offering or accepting any payment to induce federal healthcare business, is an important legal rule pertinent to clinical studies. When agreeing to participate in clinical trials, clinicians should be mindful of the risks and possible legal scrutiny under the Anti-Kickback Statute, and follow the guidance of the Pharmaceutical Research and Manufacturers of America to minimize their risk. (Clinical Leader)
Maintaining a Strong Sponsor/Site Relationship is Key to Your Study’s Success
Contributed article by Art Weber, Director of Clinical Affairs, Banyan Biomarkers Inc. One of the most important relationships that sponsors of clinical trials must manage is the one they share with their investigative clinical trial sites. As any CRA or clinical research coordinator will tell you, there is no more critical Read more
Will New Jersey’s crackdown on doctor kickbacks hurt clinical trials?
New Jersey is considering passing a new rule that would limit a physician’s compensation received from pharma companies at $10,000 a calendar year. However, according to ACRO (Association of Clinical Research Organizations), if not modified, this ceiling would also include clinical trial payments and would make it impossible to enroll a single patient in many trials, as the cost per patient of a cancer trial is around $10,000 to $20,000. A recent bill passed in California restricts such payments but leaves clinical trials out. (FierceBiotech)
CTTI Report: Recommendations for strengthening the investigator site community
Recommendations for sponsors, CROs, and health systems/private practices I. Recommendations for developing site-based research infrastructure & staff Recognize principal investigators, co-investigators, and research coordinators as key contributors to product development Provide opportunities for investigators and site staff to remain engaged in between trials II. Recommendations for optimizing trial execution and Read more
CTTI Report: “one-and-done” site investigators
Guest Blog. Maintaining a Strong Sponsor/Site Relationship is Key to Your Study’s Success
Contributed article by Art Weber, Director of Clinical Affairs, Banyan Biomarkers Inc. One of the most important relationships that sponsors of clinical trials must manage is the one they share with their investigative clinical trial sites. As any CRA or clinical research coordinator will tell you, there is no more Read more
Guest blog. BIOCOM Medical Device Breakfast: Designing and Implementing Effective Clinical Trials
Contributed article by Greg Dombal, COO, Halloran Consulting On October 12, BIOCOM’S Medical Device Committee hosted a breakfast program on designing and implementing effective clinical trials. Jeff Anderson, SVP of Clinical/Regulatory Affairs at REVA Medical and Art Weber, Director of Clinical Affairs, Banyan Biomarkers, presented their experience and lessons learned Read more
Guest blog. Interview with Dr. Victor M. Santana — Ethical Considerations in Pediatric Research
Dr. Santana frequently speaks on topics related to research ethics, including ethical considerations in pediatric research and educating medical professionals in the responsible conduct of research. We spoke with him about this. Dr. Santana is a pediatric oncologist and clinical investigator at St. Jude Children’s Research Hospital in Memphis, TN, Read more
“Unlocking the remote clinical trial”- R. Veeza reports from SDCRN May 3 program on implementing virtual clinical trials
UNLOCKING THE POTENTIAL OF REMOTE (“VIRTUAL”) CLINICAL TRIALS By Dr. Roberta Vezza Alexander San Diego, May 4, 2017 On May 3, the San Diego Clinical Research Network (SDCRN) organized a very interesting event focused on how mobile technologies could be used in clinical research. The event was at the beautiful Read more
- « Previous Page
- 1
- 2
- 3
- 4
- …
- 6
- Next Page »