2021 CDE Release: Circulars Nos. 1 and 2

On January 15, 2021 and January 18, 2021, respectively, the Drug Audit Center of the State Drug Administration issued Circular No. 1 of 2021 and No. 2 of 2021: 1. Notice of the Drug Review Center of the State Drug Administration on the Release of the Technical Guidelines for the Evaluation Procedure of Imaging Procedures for Clinical Trials of Anti-Tumor Drugs (No. 1 of 2021) No. 2, And the Drug Administration of the State Drug Administration Notice of the Review Center on the Release of the Technical Guidelines for Clinical Trials of Innovative Drugs for the Treatment of Post menopause Osteoporosis (No. 2 of 2021) to develop clinical trial imaging procedures, standardize industry operations, and clarify that technical standard anti-tumor drugs are one of the hot spots in the current global research and development of new drugs. PFS) and disease-free lifetime (disease free survival, DFS Iso-based alternative endpoints for medical imaging assessment results are increasingly used as the primary endpoints for key research to support the launch of new drugs.
imaging processing, information transmission, etc. in clinical imaging have been standardized to a certain extent, and are widely used in clinical practice.
clinical or imaging physicians analyze and diagnose medical imaging, it is usually based on subjective judgment and lesion measurement, and does not require systematic quantitative evaluation to meet the clinical needs of imaging diagnosis.
But in clinical trials, differences in the imaging examination and evaluation process can lead to increased measurement errors, increased variation in clinical trial endpoint evaluation, and ultimately affect clinical trial results, so standardization of clinical trial imaging evaluation procedures becomes very important in imaging-based clinical trials.
As more and more key studies use medical imaging-related research endpoints as the primary research endpoints, there are no technical requirements or industry standards to follow in terms of the overall design, implementation process, and data management of imaging evaluation.
, there is an urgent need to develop technical guidelines for clinical trial imaging evaluation procedure standards to standardize industry operations and clarify technical standards.
innovative drugs that guide the treatment of post-menopaphageal osteoporosis focus on Osteoporosis ( Osteoporosis ) in clinical trial design , a common chronic bone disease found in post-menopaphaltic women and older men.
with the aging of china's population, osteoporosis has become an important public health problem.
Osteoporosis fractures (also known as brittle fractures) are the most serious consequences of osteoporosis, which not only affects the quality of life of patients, but also is one of the main causes of disability and death in elderly patients, resulting in a heavy family and social burden.
osteoporosis and osteoporosis fractures are better in post-menopaphaltic women.
, postmenopausal osteoporosis (PMO) is usually the first drug to treat osteoporosis.
drugs with different mechanisms of action have been approved for the treatment of post-menopaus osteoporosis, but in the face of many patients, the treatment of osteoporosis still has unsystressed clinical needs.
Based on the published Considerations for Clinical Trials of Drugs for Post menopapa://while menopa://while still abroad,
develops these guidelines in the light of advances in clinical trials and relevant guidelines at home and abroad to further guide the development of innovative drugs for the treatment of post-menopaphosis.
guidelines focus on the focus of innovative drugs for post-menopatis osteoporosis in clinical trial design.
guiding principles represent only the current perspectives and perceptions of drug regulators, and as scientific research progresses, the relevant elements of these guidelines will be continuously refined and updated.
applying these guidelines, please also refer to the GCP, the International Coordinating Committee on Technical Coordination of Human Drug Registration (ICH), and other relevant guidelines that have been issued at home and abroad.