Watson pharmaceuticals steroids

The clinical trial design in the modern times of “advanced electronic documentation” reflects thorough incompetence and extreme laziness/ CYA attitude from all quarters. FDA is often used as a reason for all the stupidities and redundancy of paperwork. In the digital era, we are forced to maintain unwieldy, mostly useless junk in round files for ages( as source documents for electronic data ( wonder why they cannot scan the source, store in a secure cloud and destroy paper document). These round files take up enormous amounts of storage space and are so prone to destruction from the elements, not to mention termites in off-site storage. The clinical trial ECRF tools are wasteful of user’s time, rigid, utterly inflexible, poorly designed to document the nuances of patient care seen in usual clinical practice. They are designed to beat a nosy lawyer in the court of law rather than convince evidence seeking physicians with actionable information. This lack of focus on what really matters to practicing doctors in the trial design and execution may be one big reason why there are so many medical reversals after FDA approved drugs that pass clinical trials that fail in disease management in real life. There are a lot of vested interests in these trials protocol design. Consultants may be the culprits
If a supercomputer can be used to analyze any kind of data, “extract data from information”, track trends and vagaries as they emerge in trials and halt trials that are clearly faulty in design or data gathering, that might prove any of these ventures with supercomputers analyzing data, the source of information must be hard-data like patient-reported symptoms, documented events, abnormal labs data, data extraction from free text information in reports expressed in nuanced form in natural language ( not structured data entry in ECRFs), deviation from expected trends in labs- not just documents with signature and date. With the appropriate use of AI and machine learning, it should be possible to monitor compliance with the protocol without monitoring( or worse micromanaging) processes. Regulators should be doing more useful things than confirming handwritten dates and times next to signatures on paper documents whose data have been physically transferred to ECRF( sic!) .

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May 19, 2017, 12:51 ET

The CDS carve out makes it abundantly clear that Watson cannot be used as a sole clinical decision maker. The health care professional must be part of the decision making process. So basically what you have is a very expensive second opinion. If the end users are willing to pay for it that’s okay, I suppose. But remember the cardinal rule of second opinions: just because the second opinion differs from the first opinion doesn’t make the second opinion the correct one. Since Watson will always give the same opinion, a third opinion may be sought from a doctor as a defensive move. In the end the other doctor will be faced with agreeing with the recommendations of a machine or a professional colleague. That will be swell for relationships.

Watson pharmaceuticals steroids

watson pharmaceuticals steroids

The CDS carve out makes it abundantly clear that Watson cannot be used as a sole clinical decision maker. The health care professional must be part of the decision making process. So basically what you have is a very expensive second opinion. If the end users are willing to pay for it that’s okay, I suppose. But remember the cardinal rule of second opinions: just because the second opinion differs from the first opinion doesn’t make the second opinion the correct one. Since Watson will always give the same opinion, a third opinion may be sought from a doctor as a defensive move. In the end the other doctor will be faced with agreeing with the recommendations of a machine or a professional colleague. That will be swell for relationships.

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