Recently , I began to take a closer look on how to achieve quality in pre-clinical and clinical research studies. These areas, hitherto, have been neglected enough. Achieving an error free in all stages of drug development requires that every aspect of the process should be handled with utmost care. This ranges from GMP, GLP,GCP and GCLP.Discovering random, systematic and gross errors during inspections and audit requires the input of highly trained professionals in this fields. A closer look at many sites and procedures performed in clinical trial did show that deviations, which could have debilitating effects on the quality of data generated are becoming common occurrences.
In your candid opinion, kindly share how best stakeholders in the industry can reduce errors during the entire process of pre-clinical and clinical studies.
Watch out for more on this topic!.
Thank you

Reply

  • faodey Friday A Odey May 15, 2012

    I think the first step is need for training and re-training so that we can get it right. When the researchers themselves and their teams get it right, then we would have began our journey to GCP standard drug trials in Nigeria.

  • rravinetto Raffaella Ravinetto May 21, 2012

    Hallo, in my opinion, many major or systematic deviations can be successfully anticipated and prevented in the pre-study phase, if sufficient efforts are put in preparing the site for the research.

    For instance, the performance of the laboratory can be well monitored (and such monitoring can be appropriately documented) only if the arrangements for internal and external quality control, instruments calibration and maintenance, samples' identification, storage and shipping procedures etc. are done in advance. Also as an example, the performance and quality of the informed consent process may be better ensured by training in advance all the potentially concerned staff (training on the informed consent itself and on related subjects, e.g. trial insurance and indemnity), by involving representatives of the community in the preparation of the informed consent tools, and by identifying in advance a place where the interview may be conducted with the appropriate privacy and confidentiality conditions. A number of other key activities, such as the fast track reporting of SAEs and the timely and accurate data entry, cannot be successfully carried out if the rules, roles, responsibilities and procedures are not defined and understood in advance, if appropriate tools are not prepared and tested in advance, and if appropriate working conditions are not ensured before the activity starts. In fact, not only the theoretical knowledge of the guidelines is key to achieving compliance with GCP and GCLP requirements, but also the good organization of the work. Audits' and inspections' findings are often linked to the failure of standardizing the work flows and procedures as well to the failure of documenting each and every step of the clinical and laboratory work.

    Unfortunately, in externally-funded research we may have limited financial resources for pre-study visits aimed at preparing and upgrading the site. However, this pre-study set-up is essential, especially in case of sites with no or limited experience in clinical research, and non-commercial consortia could work at reciprocal supporting scheme, to learn from each others’ experience and to support each other in anticipating GCP- and GCLP-deviations, rather than dealing with them “a posteriori”. Best wishes,

    Raffaella

  • rravinetto Raffaella Ravinetto May 21, 2012

    Hallo, in my opinion, many major or systematic deviations can be successfully anticipated and prevented in the pre-study phase, if sufficient efforts are put in preparing the site for the research.

    For instance, the performance of the laboratory can be well monitored (and such monitoring can be appropriately documented) only if the arrangements for internal and external quality control, instruments calibration and maintenance, samples' identification, storage and shipping procedures etc. are done in advance. Also as an example, the performance and quality of the informed consent process may be better ensured by training in advance all the potentially concerned staff (training on the informed consent itself and on related subjects, e.g. trial insurance and indemnity), by involving representatives of the community in the preparation of the informed consent tools, and by identifying in advance a place where the interview may be conducted with the appropriate privacy and confidentiality conditions. A number of other key activities, such as the fast track reporting of SAEs and the timely and accurate data entry, cannot be successfully carried out if the rules, roles, responsibilities and procedures are not defined and understood in advance, if appropriate tools are not prepared and tested in advance, and if appropriate working conditions are not ensured before the activity starts. In fact, not only the theoretical knowledge of the guidelines is key to achieving compliance with GCP and GCLP requirements, but also the good organization of the work. Audits' and inspections' findings are often linked to the failure of standardizing the work flows and procedures as well to the failure of documenting each and every step of the clinical and laboratory work.

    Unfortunately, in externally-funded research we may have limited financial resources for pre-study visits aimed at preparing and upgrading the site. However, this pre-study set-up is essential, especially in case of sites with no or limited experience in clinical research, and non-commercial consortia could work at reciprocal supporting scheme, to learn from each others’ experience and to support each other in anticipating GCP- and GCLP-deviations, rather than dealing with them “a posteriori”. Best wishes,

    Raffaella

  • VivatThomas_Njie Vivat Thomas-Njie May 21, 2012

    My experiences are with clinical studies, and to start with a well written protocol must be in place with the relevant SOPs. The staff must be properly trained on the study protocol and study related procedures, e.g. consenting, sampling and the management of the IP. Before the start of the study there should be proper planning and this should include training plan, analytical plan, data management plan and monitoring plan. The site must have an internal review system which would help the site ensure that they are collecting credible data. The sponsor must ensure the study is monitored and audited appropriately and all findings acted upon in a timely manner to ensure corrective actions are carried out and preventive actions are in put in place.
    There must be adequate competent staff who are GCP trained to conduct the trial.
    It could be useful to test run the processes, e.g. the consent procedure. The CRF could also be piloted.
    Finally ensure good communications within the site staff, sponsor and all other collaborators.
    I would say good planning, adequate training, correct processes and effective communication would go a long way to producing credible data in clinical trials.

  • Htorres Htorres May 28, 2012

    Hello Augustine

    This is an interesting question. I agree with what has been said above.

    I am a doctor in South America and we have been reading some interesting blogs and discussions from a group on here about monitoring, and we hope to try to set up internal monitoring system within our research group soon, so that hopefully as a group we can keep on top of errors as they arise to minimise the amount of errors found at inspection and audit. We are in discussion about how to go about doing so, and I would be very interested to hear whether anyone has tried this to improve their internal QA, and if so what worked and what did not!

    Thank you all
    Helmutt

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