Clinical trials fail. That is a fact of life as a recent study (2015, Clinical Development Success Rates for Investigational Drugs) found that 90 percent of drugs that reach clinical stage development never make it to FDA approval and commercialization. Only half of all drugs are rejected during the process and fail due to a lack […]
Not all software is regulated by FDA. Some software may be regulated depending on what it does. You can take a lot of what we know about clinical trials and design them for the task. FDA does not regulate the software. They take a hands-off approach. They let companies design systems to work for them. […]
Clinical Trial Feasibility Studies means finding the right investigators and patients then determining costs. It is done to evealuate how the test could fail then decide to proceed or not to proceed. The project manager and trial sponsor take the lead. They look at the records of investigators and see if they are able to […]
Clinical Trial Project Managers are are not necessarily using the newest technologies in the marketplace. Microsoft Project is popular but it is twenty-years old. Inertia is the main reason for not switching to the new technologies. Most technologies require a learning curve and project managers are averse to doing it because it takes time to […]
Clinical Trials take too long to start. The clinical trial managers may not start a trial from 6-9 months to even 12 months. This is more time than it should. Research has shown that many prescription drug companies accept inefficiency. The threshold is much too high for inefficiency. Many clinical trial tools are antiquated, such […]
Clinical Trial costs can be controlled and reduced by following protocol. Drug trials have been done the same way for the last fifty years or so. There have been very few changes in protocols. Clinical Drug Trials need a team of technicians, doctors, nurses and administrators who do the project step-by-step and stay within 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, […]
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. […]
Complex project management for clinical trials is a very critical part of the clinical drug trials planning. Most clinical trials typically run 45% over budget. There are several reasons for this occuring: 1. Lack of discipline in being able to manage a complex project. 2. Lack of understanding of your resources. 3. Financial data: Unable […]
Each country has its own rules and protocols for its clinical drug trials. Operationally, however, drug trials, including foreign ones, follow a universal standard. “Good Clinical Practices” is the manual used around the world for clinical trials. (Administrative and legal forms vary from country to country.) If the clinical trial is done well, then you […]