” not clinical medicine…”-1BOM
Tuesday 9 April 2013
“My own beefs about the RTC culture that developed are multiple. The Clinical Research Industry that developed uses recruited subjects which hardly mirror the treatment seeking patients psychiatrists deal with in their offices. The RTC aims at statistical results rather than clinically significant results. The methodology of analyzing the data allows for a seemingly infinite variety of techniques to distort the reports. And the requirement for two positive studies allow for throwing out unwanted results from efficacy evaluations by simply not reporting negative trials. The net effect is that this seeming scientific reform can and has been distorted beyond anyone’s imagination. Those are the pieces that Ben Goldacre and the Data Transparency movement are setting out to make right. Data Transparency addresses a lot of those ills.”
“How Can We Draw the Line between Clinical Care and Medical Research”
PLoS Med. 2007 November-PLoS Med editiors.
“Misinterpretation of the boundary between research and care may have serious consequences. On the part of research participants, such misunderstanding might result in individuals enrolling in research studies believing that their physician will offer therapy that is, in the doctor’s clinical judgment, the best approach for the patient personally, rather than a therapy governed by the research protocol. In another scenario, researchers who offer a treatment that is in some way different from standard or accepted practice might consider that treatment to be “off-label” prescribing, or a refinement of a surgical procedure, rather than a formal clinical trial, and fail to adequately protect the patient through ethical review and informed consent processes .
Given the potential for misinterpretation of the primary purpose of research, which is to collect data for the purpose of contributing to scientific knowledge, what are the requirements that must be fulfilled for involvement in a trial to be considered ethical? Many ethicists consider that, in addition to the crucial safeguards outlined in the Declaration of Helsinki , two additional criteria must be fulfilled (debated in ). Firstly, the clinical community as a whole should be uncertain as regards which of the treatments being compared is better (a scenario termed “clinical equipoise”); and secondly, completion of the trial should be likely to alter the balance of that equipoise. Importantly, Henderson et al. highlight the researchers’ uncertainty with respect to risks and benefits as a key dimension of research that trial participants must understand in order to provide valid consent.”
The problem is that CROs are under the expectation by the many stakeholders to produce positive results or results that can be spun. Because this has been entrenched for three or four generations no one really questions
the process until some disaster occurs like the surreal data. The real problem is the many overlapping and conflicting gears that run the smaller cogs-the CROs.Note how “research” and “therapy” sort of causually merge into a singular package and are sold as such.The problem is why larger gears need CRO’s to begin with, the presentation of CRO’s.
“Institutional Review Board Liability for Adverse Outcomes”
AMA Virtual Mentor. April 2009, Volume 11, Number 4: 306-310.
“I point out to you, Marcus Claire Luyseyal, a lesson from past over-machined societies which you appear not to have learned. The devices themselves condition the
users to employ each other the way they employ machines.”
― Frank Herbert, God Emperor of Dune