Clinical Trials are mammoth projects. They may be staffed by 200 people or more. Doctors, nurses, technicians, administrators, interns and others are involved. Anyone of them can make a mistake duing the trial which can cause huge problems or ven delay the completion of the project. They are, however, controlled by the parameters of the […]
Safety precautions take during clinical trials are certainly the most important aspect. There are two groups which have scientific oversight: the sponsor and the physical investigator (doctor). Additionally, the FDA reviews them along with independent review boards. There is also “Informed Consent”. A patient consents to all the trial rules before the trial begins. Thus, […]
There are many reasons why a clinical trial can be delayed. The main reason for delay is bad planning. Other reasons include: recruitment, data cleaning and proper documentation. “Lack of Efficacy” is an important aspect of clinical trials. Efficacy is the effectiveness of the drug in curing the disease. However there are many drugs which are […]
Twenty tree years after the NIH created the Revitalization Act to increase the number of women and minorities in clinical trials, they still seem under-represented in drug trials. Is that still the case? There were some well-known drug trials where minorities were mistreated. Women were not even allowed to participate in trials for a long […]
The new Trump Administration will be overseeing clinical drug policy. The big question is: How will this new administration affect clinical trials? Clinical trials are rarely influenced by the politics. Most clinical trial rules are fifty years old and well-established as are international standards. . The Trump Administration has talked about cost reduction of drugs. […]
Many segments of the American population do not participate in clinical trials. These same patients also rarely give feedback on the drugs they are taking. However, that can be improved as there are several ways patients can help with developing different prescription drugs: If you have a disease, get involved with your patient support groups. […]