Re: nidan7500 Post# 231019 Post Trial Access (“PTA”) Article regarding same for the EMA
[It would appear to me that the international ethical guidelines such as the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS) guidelines would provide ample authority for Anavex to continue providing blarcamesine access to the PDD participants immediately after their trial period ended under the Compassionate Use Program or Expanded Access Programme as long as it was disclosed to participants during the informed consent process, irrespective of whether Spain/EMA posted an official OLE start date on their website.]
“Medicines for the European market are increasingly being tested on clinical trial participants in low- and middle-income countries (LMICs), where most participants are poor and have limited access to health care. Against this backdrop, the entitlement to Post-Trial Access to Treatment (PTA) after the trial has ended becomes increas- ingly important to avoid the exploitation of vulnerable participants. The problem is that patients are being enrolled onto clinical trials in the full knowledge of the trial sponsors that they will not have access to the continuing treatment they may need once the trial has finished. This practice is unethical.
“Because I will get into this trial, I get better, and then afterwards I am going to die. You have promised me life and then you take it back; that’s not fair.” HIV/AIDS Clinical Trial Participant, Kenya 2006
The Good Clinical Practice Guidelines of the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH),1 which have been integrated into European legislation,2 comprehensively describe the responsibilities and expecta tions of those involved in the conduct of clinical trials. However, these guidelines do not describe any responsi bilities for continuing treatment after the trial. Leading international ethical guidelines such as the Declaration of Helsinki and the Council for International Organizations of Medical Sciences (CIOMS) guidelines include the right to PTA, but they use different wording and still raise many questions. This lack of firm guidance is fuelling a heated academic debate about fundamental ethical questions regarding the treatment of patients after clinical trials.
“In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for post-trial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.” (Article 34, Declaration of Helsinki 2013.”
“ PTA should be ensured for all participants in the trials (Nuffield, CIOMS/WHO), and undoubtedly for those who still need an intervention identified as beneficial (DoH).”
“The principle of nonmalfeasance (do no harm) is undisputed in medicine, and most arguments in favour of PTA refer to it. A drug that has proven to be beneficial to someone cannot be withdrawn. Moreover, when it comes to LMICs, the principles of justice and global ethical standards are evoked and contribute to an increasing consensus on the desirability of PTA.”
“ 2013 Declaration of Helsinki, article 34:12 “In advance of a clinical trial, sponsors, researchers and host country governments should make provisions for posttrial access for all participants who still need an intervention identified as beneficial in the trial. This information must also be disclosed to participants during the informed consent process.”
“ CIOMS/WHO Guidelines, guideline 10:14 “Before undertaking research in a population or community with limited resources, the sponsor and the investigator must make every effort to ensure that: (...) any intervention or product developed, orknowledge generated, will be made reasonably available for the benefit of that population or community.”
CIOMS/WHO Guidelines, commentary to guideline 10:15 “If an investigational drug has been shown to be beneficial, the sponsor should continue to provide it to the subjects after the conclusion of the study, and pending its approval by a drug regulatory authority.”
“ Commitments to PTA There is a definite lack of clear company commitments in reference to the right to PTA. There was one clear statement on Novo Nordisk’s website: “Clinical trial participants should have access to best proven and available treatment after a trial has stopped”.43 Although not comprehensive, PTA is mentioned in various company policy documents. All nine companies analysed for this research have included the Declaration of Helsinki (DoH) in policy documents on their websites. Either as a reference instrument for human rights (Sanofi44) or as an international ethical guideline the company “follows” (GSK45) or “adheres to” (Gilead,46 Eli Lilly,47 Novartis48) or “complies with” (AstraZeneca,49 Pfizer50), or operates “in accordance with” (Bayer51), or “in full conformance” (Roche52). Including the DoH unreservedly can be seen as a commitment by companies to acknowledge the entitlement to PTA.”
“ The preferred routes for PTA The emerging standard practice for providing an unlicensed investigational drug until marketing approval is: 1 By enrolling the participants into a study extension (an Open Label Extension Study (OLE) or LongTerm Extension Study (LTE). 2 Through one of the forms of Early Access Programmes (EAP), depending on the national regulatory framework in place. Related to point 2, in the US, the Food and Drug Admini stration (FDA) regulation67 allows access through “Expanded Access Programs”, while EU regulation68 allows such access through Compassionate Use Programmes (CUPs). There are Cohort CUPs (CUPs made available for groups of patients or hospitals on the basis of requests from physicians or companies69) and Named Patient CUPs (CUPs made available for individual patients on the basis of the physician’s request70).”
“ Characteristics of the most common PTA practices OLE Description: An extension of a clinical trial on the basis of a new study protocol in which the participant, healthcare professional and others know the drug and dose being given (not blinded). Aim: It is conducted to assess the longterm safety and tolerability of an Investigational New Drug but is also used for continued prescribing of unlicensed medicines after a randomised trial to patients with medical need of the investigational medicine. Compassionate Use Programs (CUP) or Expanded Access Programmes (EAP) Description: An early access programme is a way of making a promising medicine available to patients when it has not yet been authorised (licensed) for their condition.71 Aim: To make available unlicensed medicines on the basis of compassion but also used to provide a PTA. Compassionate Use Programmes and Expanded Access Programs can be considered substantially equivalent on the basis of the following characteristics: a) the compassionbased drug provision; b) the drug is not yet authorised; c) no alternative therapy is available; and d) there is no research objective or study protocol involved.”
“Although considering Open Label Studies as their current standard, GSK seem to be in the process of considering a transition to a different practice. A spokesman said that, if an OLE is based only on the ethical need to supply the drug to the trial participants who benefited from the drug, then the drug should be provided with more clinical freedom and without the limitations of clinical trial protocols and the requirements for clinical data collection. Therefore the company’s standard may shift from an OLE to an Expanded Access Program. GSK has produced a new protocol on this topic, which is expected to be rolled out soon.75”
Replies: Thanks Bear77, great information. nidan7500 on 1/18/2020 10:57:01 AM Indeed it would very odd if not unthinkable Investor2014 on 1/18/2020 11:00:02 AM Thank you polarbear77! It is clear now JWC3 on 1/18/2020 11:12:21 AM
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