nidan7500 Monday, 06/03/19 04:44:16 PM Re: Jonjones325 post# 195307 Post # of 232649 Thanks jonjones325: https://mrctcenter.org/wp-content/uploads/2017/12/2017-12-07-Post-Trial-Responsibilities-Toolkit-Version-1.1.pdf Text: The amount of information known about the investigational medicine (which varies by trial phase) is one critical factor in the determination of who is responsible and for what: in early phases of drug development, whether patients benefit from the drug, what risks are attendant with drug administration, and toxicity of the drug may be unknown or inadequately studied. Both while the investigational medicine is in development and while awaiting approval, the sponsor should investigate whether suitable safe and effective alternatives to the investigational medicine exist, and whether discontinuing the investigational medicine and/or transitioning to a suitable alternative could potentially harm the patient. In general, where no such alternatives exist for a serious or life-threatening condition and when the patient has shown benefit from the product, provision of continued access is indicated. If the investigational medicine is not approved by the regulatory agency, the sponsor must respect the local regulatory authority and discontinue provision. On very rare occasions, the sponsor may elect to engage with the government to determine if an exception may be made for the individual patient. Where suitable alternatives exist, if the risks are significant or the product is shown to be ineffective, no further access to the investigational agent is recommended and responsibility for patient medical care will shift to the healthcare system. I cannot imagine how the decision process driven by this document could possibly be effective under today's paper driven process conditions. A precision medicine, case by case, digital technology complimentary system would ensure technical consistency. I would not want to do that job w/o strong systems support.