-
Categories
-
Pharmaceutical Intermediates
-
Active Pharmaceutical Ingredients
-
Food Additives
- Industrial Coatings
- Agrochemicals
- Dyes and Pigments
- Surfactant
- Flavors and Fragrances
- Chemical Reagents
- Catalyst and Auxiliary
- Natural Products
- Inorganic Chemistry
-
Organic Chemistry
-
Biochemical Engineering
- Analytical Chemistry
-
Cosmetic Ingredient
- Water Treatment Chemical
-
Pharmaceutical Intermediates
Promotion
ECHEMI Mall
Wholesale
Weekly Price
Exhibition
News
-
Trade Service
Rick Pazdur, MD (Image: AACR)
Director of FDA Pazdur has frequently appeared on the "hot search in the drug circle" recently, and has been controversial due to the Cinda/Lilly ODAC meeting.
Dr.
Insights into PD-1 racetrack clustering and involution
The title of the article is "The Wild West of Checkpoint Inhibitor Development" (Image source: NEJM official website)
On February 4 this year, a few days before the Cinda/Lilly ODAC meeting, Dr.
Importing oncology trials from China: is it a bridge through the storm?
(Image source: Lancet official website)
Just now, Director Pazdur published an important article "Reexamination of Patient Autonomy and Prior Therapies in Oncology Clinical Trial Eligibility Criteria", which once again discussed the eligibility criteria for oncology clinical trials and whether patients should be under the guidance of doctors They have the right to make their own decisions about enrolling in clinical trials and are not bound by "eligibility criteria"
Discussed again the eligibility criteria for oncology clinical trials, and whether patients should have the discretion to enroll in clinical trials under the guidance of doctors, rather than being bound by "eligibility criteria"
In addition to Pazdur, M.
Pazdur MD Julia Beaver MD Jen nifer Gao MD
Had to take the FDA! There are many scholars with strong backgrounds
The abstract of the article is as follows
The abstract of the article is as followsOver the past decade, with more than 100 new molecular entities and innovative biologics approved, tremendous progress has been made in the global medical field
Many patients are limited by strict "clinical trial eligibility criteria" to participate in potentially life-saving clinical trials Enroll all patients with untreatable cancer in cancer clinical trials
The existence of clinical trial eligibility criteria ensures patient safety toa certain extent.
Ensuring patient safety Recruiting similar patients provides a framework that may delay their optimal timing for entering clinical trials, ultimately losing the chance of being cured by a novel drug or potentially effective drug they still hope to enter into such an early-stage clinical trial
There are two reasons
Experimental drugs may target tumors with specific genotype mutations or specific tumor markers, so as to achieve personalized treatment for patients and achieve better efficacy
An investigational drug may have a better-quality route of administration, resulting in better initial data, or have fewer side effects than existing treatments
Whatever the reason, patient autonomy and physician decision-making should be respected
Patient autonomy and physician decision-making should be respected
In addition, expanding trial populations can improve our understanding of drug applicability and safety, in
It can also improve our understanding of the suitability and safety of the drug.
Jennifer Gao, MD, is the Deputy Director of Education at the FDA's Oncology Center of Excellence and has been with the FDA for 5 1/2 years
Jennifer Gao, MD, is associate director of education at the FDA Oncology Center of Excellence
Julia Beaver, MD, is the Director of the FDA's Division of Medical Oncology
Julia Beaver, M.
D.
, is Director of FDA Medical Oncology
Epilogue
Epilogue When China's new drugs are going overseas and the FDA is challenged by clinical trials, insight into Director Pazdur and the FDA's attitude towards clinical trials may have a certain guiding role in sprinting into the US market in the future
.
Medicine Times will continue to pay close attention and continue to report, and friends are welcome to pay attention
.
