Sponsors and their contractors have faced challenges when ensuring that parties involved in global clinical trials adhere to rules and regulations regarding biomedical research. For an effective collaboration to take place, all parties must meet the expectations and accountabilities detailed in the trial contract.
Some in the financial industry have argued that we may be in the midst of another economic recession. The biopharmaceutical industry has shown resiliency during such times and industry trends point to that being the case again.
The Movement Disorders Society has recently published Clinical Diagnostic Criteria for Parkinson’s disease. These new guidelines allow for the diagnosis of clinically established and clinical probable Parkinson’s disease, which will help reduce errors in clinical trials.
The European Reference Network aims to join the efforts of the best specialists in Europe to tackle complex or rare medical conditions. The goal is to create networks covering a specific disease with an emphasis on procedures or techniques related to treatment.
Months of rumblings across Europe that the scheme to promote orphan drugs is being abused by drug firms to maximize profit instead of innovation have been heard. Those rumblings have now turned into shouts.
The FDA’s breakthrough drug initiative is accelerating clinical development of new therapies. A recent analysis found that pre-market development time for breakthrough-designated drugs is 2.2 years shorter than for those without the designation.