Clinical Trials

Clinical Trials News

ASCO T-DM1 Improves Outcomes in HER2-Positive Breast Cancer The experimental agent T-DM1 significantly improves progression-free survival in HER2-positive metastatic breast cancer, compared with standard therapy.
Medscape Medical News, June 3, 2012
ASCO PD-1 Agent 'Breaks Ceiling' in Cancer Immunotherapy A new approach to immune therapy produced durable responses in patients with advanced melanoma, renal cancer, and nonsmall-cell lung cancer.
Medscape Medical News, June 2, 2012

ASCO What's Hot at ASCO This Year?
Medscape Medical News, May 25, 2012
AUA What's Hot at AUA 2012?
Medscape Medical News, May 18, 2012
U.S. May Speed Approval of 'Breakthrough' Drugs
Reuters Health Information, May 11, 2012
Pharma Companies, Publishers Agree on Publishing Guidelines
Medscape Medical News, May 10, 2012

Regulating Metabolism: From Obesity to Cancer A better understanding of metabolism has led researchers to explore its role in diabetes, obesity, and cancer. What are the implications for clinical practice?
Developments to Watch, May 31, 2012
Proton Pump Inhibitors: The Latest News Dr. David Johnson reviews the up-to-the-minute news, research, and alerts related to proton pump inhibitors, distinguishing what is sound from what is just noise.
Medscape Gastroenterology, May 31, 2012

Compassionate Use: A way to provide experimental, not-yet-approved treatment to patients who are critically ill and are not responsive to other treatments. Physicians may need to get case-by-case approval from the FDA for "compassionate use" of a drug or therapy.
Inclusion/Exclusion Criteria: These determine whether an individual may take part in a clinical trial. Criteria are based on age, gender, the type and stage of a disease, previous treatment history, and other medical conditions.
Investigational New Drug Application (IND): After preclinical testing, a company files an IND with the FDA to begin to test the drug in humans. The IND becomes effective if the FDA does not disapprove it within 30 days. The IND describes prior experiments, the new study protocol, the composition and manufacture of the investigational drug, and any toxic effects found in the animal studies.
Orphan Drugs: Medications for diseases and conditions that occur rarely. Pharmaceutical companies have little financial incentive to develop drugs for these diseases. Orphan drug status, conferred by the FDA, gives a manufacturer specific financial incentives to develop such medications.
Phase 3: A drug that shows positive results in small groups of patients may be studied in a larger phase 3 trial to confirm its efficacy and note adverse events that occur with long-term use. Hundreds or thousands of patients may be involved.

How to Start Doing Office-Based Clinical Trials
Physicians looking for new revenue sources and patient services should consider conducting clinical trials, which bring in revenue and are valuable services.
Personalized Medicine, June 9, 2010
Clinical Trials Can Boost Your Bottom Line -- Are They Worth It?
Office-based physicians can earn significant revenue by conducting clinical trials. Here's a look at the pros and cons to decide whether trials are right for a practice.
Medscape Business of Medicine, June 2, 2010

Steering Committee

Carmen Arismendy, MD, CCRC
CEO and President, Arysmed LLC, Ridgewood, New Jersey
www.arysmed.com
Dr. Arismendy is a Certified Clinical Research Coordinator. She has previously worked as a research coordinator at Mt. Sinai Hospital in New York City and in clinical investigation with New York University Hospital.
Kenneth A. Getz, MBA
Senior Research Fellow, Tufts Center for the Study of Drug Development (CSDD), Tufts University, Boston, Massachusetts Founder and Chairman, Center for Information and Study on Clinical Research Participation (CISCRP) and CenterWatch, Boston, Massachusetts

ClinicalTrials.gov
A registry of federally and privately supported clinical trials conducted in the United States and around the world.
CenterWatch
A source of news, directories, proprietary market research, and analysis for clinical trials professionals and patients.
Tufts Center for the Study of Drug Development
An independent, academic, nonprofit research group involved in the development and regulation of new therapeutic agents.
Center for Information and Study on Clinical Research Participation
A nonprofit organization that educates the public, patients, and medical/research professionals about the role each party plays in the process.