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    Home > Medical News > Medical World News > FDA Clinical TrialS Guidelines and Five Updaterevisions during the COVID-19 pandemic.

    FDA Clinical TrialS Guidelines and Five Updaterevisions during the COVID-19 pandemic.

    • Last Update: 2020-08-03
    • Source: Internet
    • Author: User
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    Less than two months after its release, the FDA has revised the guidelines five times, so that it is rare to "frequently" revise the guidelines that "take effect immediately from the date of publication." How to strictly abide by the relevant regulations, under the premise of full y/her regulatory flexibility, according to the actual situation, make timely adjustments? While ensuring the integrity and safety of clinical trials, how can we leverage the tools available in the toolbox to resolve challenges, minimize the damage caused by outbreaks, and ensure the advancement of clinical trials?
    respond to a century-old pandemic, in addition to hospitals need to reconfigure and adjust their power, curb ingenuity COVID-19 global spread related to a number of measures, including maintaining social distance, these measures inevitably affect the development of new drugs and other pharmaceutical products development process. Public health and drug regulators recognize that the risk of exposure to or infection of COVID-19 in clinical trial sites, travel restrictions, disruption of the drug supply chain, and exposure to or infection of subjects and medical personnel can lead to difficulties in meeting specific processes set out in clinical and human trial protocols. Despite the disruption, there can be no compromise under any circumstances with regard to the strict requirements for ensuring the integrity and safety of drug development.
    to maintain the integrity of clinical trials and minimize the costs of indefinite lysizing on clinical trials, the FDA has issued guidelines to support the exploration of important research and new therapies. In addition, the Office of Human Research and Conservation (OHRP) of the Department of Health and Human Services (HHS) has issued guidelines to help researchers properly apply human subject protection regulations.
    to reduce the disruption of clinical trials while maintaining a social distance requires compliance with the compliance criteria set out in the research programme. In response to these exceptional circumstances, the FDA has issued and revised guidelines several times to assist sponsors and researchers in ensuring the integrity of clinical trials and the safety of clinical trial participants during the COVID-19 pandemic.. On March 18, 2020, the FDA issued the Guidelines for Clinical Trials of Pharmaceutical Products during the COVID-19 Public Health Emergency Period (hereafter referred to as the FDA Guidelines). This guidance for industry, research, and ethical review boards (IRB) provides specific guidance to the bidders to minimize the risks to the integrity of clinical trials during the COVID-19 pandemic while ensuring the safety of subjects and complying with the Pharmaceutical Clinical Trials Quality Management Practice (GCP).
    recommend that the organizer consult with the researchers and the Ethics Review Committee (IRB) to determine whether they can continue to participate in the trial to maximize the safety of participants, in accordance with FDA guidelines. Since participants may not be able to travel to the research site to complete the consultations provided for in the clinical trial scenario, the sponsor may consider alternatives that ensure safe diagnosis, such as telephone contact, virtual access, etc. For COVID-19 screening procedures enforced by the healthcare system, there is no need to report in programme revisions, except for situations where relevant data are required to be collected as part of a new study objective.
    , in order to eliminate direct harm or protect the lives of research participants, if the pilot protocol must be changed, the initiator may make changes before IRB approval or before the application for a new drug clinical trial or device clinical trial (IND or IDE application) is revised, but must be reported afterwards. The applicant must state in the case report form the basis for the lack of information due to changes in the way the study is treated, or by the discontinuation of the patient's medication, and for reasons related to the COVID-19 pandemic. If changes need to be made to the efficacy evaluation, the FDA recommends that the applicant consult with the appropriate review department to discuss changes to the data collection scheme for the endpoint of the efficacy, for example, to a virtual evaluation, or to postpone the evaluation.
    finally, if the policies and processes are not in place, the FDA recommends that the organizer develop policies and procedures to protect participants in the trial during the pandemic. For all clinical trials affected by the COVID-19 pandemic, the FDA requires the sponsor to indicate in its clinical study report the contingency measures taken for studies interrupted by the relevant response, to list all participants affected by the outage, and to analyze and discuss the impact of responses to the COVID-19 pandemic on the safety and effectiveness of the study results. In accordance with 21 CFR 312.30(b) and 21 CFR 812.35 (a), amendments to the relevant act may be required as policies and processes change.
    first revised on March 27
    March 27, 2020, the FDA updated the guidelines to provide the first time in the relevant guidelines appendix, in the form of a question-and-answer session, more specific information on the challenges faced by clinical trials, such as how to ensure patient safety, how to obtain informed consent from isolated patients. The annex to the guide, updated on 27 March, contains 10 questions and answers. This was followed by more timely iteration updates in the revisions to the guidelines issued on 16 April, 11 May and 14 May, bringing the total number of questions and answers to 22.
    revised for the second time on April 16
    a new question-and-answer session on April 16th focused on how to help the bidders in the event of limited electronic and remote functionality. For example, if a researcher is not able to obtain an electronic version of informed consent, it will be possible to conduct informed interviews by fax, e-mail documentation, or over the phone. It is considered appropriate, with due consideration in advance, through remote execution and interview-based outcome evaluation, as well as remote monitoring of the relevant test sites. According to the updated guidelines, if the applicant encounters technical difficulties and has consulted the FDA for electronic submission, the applicant may request an exemption from eCTD within a limited time limit. According to the updated appendix, commercially available drugs are permitted where the subject is unable to obtain the drug from the test site, but the product has been approved by the FDA for use in other indications. In such cases, the applicant shall reimburse the subject for the purchase of commercially available medicines.
    's third amendment on 11 May
    a new question-and-answer session on May 11, on alternative laboratories or imaging centers, as well as the use of video conferencing and post-marketing requirements (post-marketing requirements, PMR). The suitability of the relevant alternative institution for the use of data provided by an alternative laboratory or imaging center depends on whether the specific process escher in the clinical trial scenario is relevant to qualification criteria, safety evaluation, or endpoint evaluation. In other words, if a laboratory test or imaging test is performed to evaluate safety, alternative agencies can be used as long as they follow the usual procedures, such as blood routines, chest X-rays, etc. However, if the results of laboratory tests or imaging evaluations are used as a basis for a formal hypothesis test, the applicant shall consult the review department as to the applicability of the alternative agency. Similarly, baseline testing should be discussed with the review authorities on the use of alternative laboratories or imaging centres to characterize the population subjects. All alternative laboratories conducting testing should be certified by the Clinical Laboratory Improvement Amendments (CLIA) and comply with other requirements under the Act.
    in addition, when using video conferencing for remote tours, the FDA recommends that the organizers consider training researchers or researchers to ensure that procedures to protect the privacy of subjects are in place and require that the identities of the researchers and participants in the trial be identified before participating in video conferencing. The appendix to the new revised guide states that interaction through videoconferencing is not considered electronic records and therefore not subject to 21 CFR Part 11 for electronic records and electronic signatures.
    updated appendix also notes that FDA guidelines apply to all clinical trials, including those required for post-marketing requirements (PMR). If the sponsor anticipates that a related issue caused by COVID-19 will cause a delay in the expiration date required for a clinical trial of a drug or biological product, the FDA should encourage the sponsor to immediately notify the FDA of a feasible revised node for use in the interim, clinical trial completion, and final report submission. Similarly, applicants should be encouraged to contact the FDA and propose revised nodes if there is an expected delay in the completion of post-market device research nodes. In communicating with each other about possible delays, the bidder should provide instructions on how COVID-19 affects the ability to reach the node initially set.
    the fourth amendment on May 14
    in an update released on May 14th, the FDA provided recommendations for the serious adverse events (SAEs) report. The FDA stresses that if SAEs are an accident, but there is a reasonable possibility that SAEs will be associated with drug research, they should report SAEs. If an unexpected SAEs occur during a clinical trial of an approved drug under study under the IND application, and the sponsor determines that SAEs are related to the drug under test, the relevant SAEs must be reported in the IND Safety Report. If SAEs occur during clinical practice or during clinical trials and indicate the potential for new serious risks associated with it, an IND safety report should be submitted. To assess whether there is a causal relationship between coVID-19 complications and the drug under test, the FDA recommended that the applicant compare the incidence of SAE among participants in the trial group infected with COVID-19, compared with the incidence of SAE observed in the control group or in the external population.
    the fifth revision on 3 June
    a revised version of the guidelines issued on 3 June this year, supplementing the instructions for obtaining informed consent for electronic signatures and conducting remote evaluations during clinical trials. The FDA recognizes that program deviations can be unavoidable due to changes that occur after a pandemic. As a result, the guide adds a new question-and-answer program to compliance with the electronically signed clinical trial recording electronic system 21 CFR Part 11. The newly revised question-and-answer session specifically cites the FDA's COVID MyStudies application as an example of an acceptable electronic method for obtaining informed consent. The app is now available for download on Android and Apple platforms.
    the FDA does not certify that existing software systems meet federal regulations for electronic signatures, but vendors can provide information to the bidders to assess compliance. In the absence of an electronic signature system that meets the requirements of 21 CFR Part 11, other methods must be used to obtain the required signature, either with an ink pen signature, a stylus signature, or a hand-drawn electronic signature that can print out and save on a related document.
    updated the guidelines and added information on the Remote Clinical Outcome Evaluation (COA) question-and-answer session. The FDA included four separate COA types in the update that can be operated remotely in clinical trials conducted in the context of the COVID-19 emergency. The four TYPES OF COA include performance-based outcomes, interviews-based clinicians reporting outcomes, patient report outcomes, and observer report outcomes. The guide recognizes that some bidders may be making personal evaluations of the participants in the trial, and that remote evaluation methods may be used for other trials for security reasons or local government guidelines and restrictions.
    guidelines say that in deciding whether to change its clinical trial scenario to include a remote clinical outcome evaluation (COAs), the bidder should evaluate a set of considerations that cover general and specificity. General considerations, including the likelihood of increased variation in the data, the possession of applicable technologies, ensuring applicable documentation, audit trails, and the overall feasibility of a given assessment method.
    for performance- and interview-based clinical study outcomes, the bidder should consider whether the remote evaluation method is appropriate for the evaluation of clinical study outcomes. Researchers should receive appropriate training in remote evaluation management. At the same time, the environment of clinical trial participants should be evaluated to ensure privacy protection, safety and suitability.
    , according to the newly revised guidelines, when some evaluations cannot be completed with remote contact, researchers should use documentation, and the sponsor should be in the clinical trial data set, reporting the evaluation portion that cannot be done remotely. The biddershoulde to consider whether the information collected remotely is sufficient to reliably evaluate clinical outcomes and support the relevant studies to draw reliable and robust conclusions.
    for the outcome of patient reports and observer reports, the specific considerations listed in the new revised guidelines include the possibility of missing data when switching from face-to-face evaluations to remote evaluations. It should also be noted whether the transition from paper or electronic outcome evaluation to oral management evaluation leads to bias. In particular, the Guide states that data collected through oral management evaluation methods is not a substitute for the necessary security monitoring.
    guidelines indicate that, in order to minimize the bias that can result from the use of oral management in the evaluation process, the applicant should ensure that interviewers are trained and that pre-prepared interview scripts are used in interviews. Bidders may also consider using automated virtual interviewers or trained neutral third-party interviewers to manage evaluations remotely.
    guidelines issued by the Office of Human Research Protection (OHRP) of the Department of Health and Human Services (HHS) for the broader health care research industry. On April 8, 2020, OHRP issued the COVID-19 OHRP Guidelines (hereafter referred to as the OHRP Guidelines) to assist researchers in the rational application of human subject protection regulations during the COVID-19 pandemic (45 CFR Part 46). OhRP's guidelines are different from those issued by the FDA in terms of the target audience and focus. The guidelines issued by OHRP emphasize public health and safety priorities for all medical researchers and by emphasizing the protection of human subjects. Under the OHRP Guidelines, measures taken for clinical or public health reasons are not considered research protocols and do not require the approval of the Ethics Review Committee (IRB) prior to implementation. For example, mandatory COVID-19 screening procedures for patients in the relevant hospitals do not require IRB review. Similarly, the relevant institutions and public security.
    This article is an English version of an article which is originally in the Chinese language on echemi.com and is provided for information purposes only. This website makes no representation or warranty of any kind, either expressed or implied, as to the accuracy, completeness ownership or reliability of the article or any translations thereof. If you have any concerns or complaints relating to the article, please send an email, providing a detailed description of the concern or complaint, to service@echemi.com. A staff member will contact you within 5 working days. Once verified, infringing content will be removed immediately.

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