Pharmaceuticals Best Practices

Perform Routine Reviews of Data During Each Trial Phase to Improve Data Quality and Accuracy

Best Practice (Good)

Perform routine reviews of data, whether remotely or during a monitoring visit, during each trial phase. Identifying data quality issues early on allows discrepancies to be addressed and resolved before they can grow into significant problems. Furthermore, by retraining site personnel and establishing preventative measures, similar issues can be averted, thus increasing data quality and accuracy.

Typical Practice (Bad)

Perform data quality reviews after each clinical trial phase is complete. Major discrepancies should be explained, documented and resolved, if possible. If a data-related issue is unable to be resolved, attempt to restart the clinical trial phase to acquire new data.

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Benefits:

Routine data quality reviews performed while each clinical trial phase is running not only prevents small discrepancies from growing into unmanageable problems, but also ensures that the quality and accuracy of all resulting data is kept as high as possible. If clinical trial data is inaccurate, the trial results will not be able to truly describe the proper effects of the products being created, thus making the trials useless to sponsors.

Submit a Fully Completed NDA to Reduce the Time and Money Spent on Approving a Drug

Best Practice (Good)

Ensure that all necessary documentation is submitted to the U.S. Food & Drug Administration (FDA) upon the first completion of a New Drug Application (NDA), even if it takes a little longer. Enforce the use of a checklist to ensure that the reports for all studies, data and analysis (from preclinical data to Phase 3 trial data) is included.

Typical Practice (Bad)

Include as much information as possible in an NDA before submitting it as early as possible. The speed of submission is important since the FDA may decide to deny the approval of a drug due to a missing piece of information. Should that happen, reapply with the added piece of information as soon as possible.

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Benefits:

Ensuring that an NDA includes all of the necessary documentation on its first submission reduces both the amount of time and money spent attempting to get a drug approved. NDAs should include clinical results, proposed labeling, safety updates, drug abuse information, patent information, any data from studies that may have been conducted outside of the United States, institutional review board compliance information and the directions for proper use of the drugs.

Triage Pharmaceutical Product Safety Updates Based on Seriousness of Risk to Expedite Dissemination of Information

Best Practice (Good)

Expedite the submission of pharmaceutical product safety updates to the FDA concerning serious and previously unidentified risks (exposure to death, prolonged inpatient hospitalization, significant disability or incapacity, etc.). Less urgent safety issues (dosage is not as effective as stated, exposure to drowsiness and other non-serious symptoms not labeled, etc.), on the other hand, should be submitted to the FDA periodically. All reports should include detailed adverse effect descriptions which pharmaceutical manufacturers have been informed of (includes adverse effects effect reports from health care providers and patients), as well as all available study results, whether published (including those published in other countries) or not.

Typical Practice (Bad)

Provide the Food and Drug Administration (FDA) with periodic pharmaceutical product safety reports which contain detailed descriptions of both serious and less urgent adverse effects. These reports ensure that everyone is kept up-to-date on the effects of new drugs and allows for accurate label updates.

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Benefits:

Submitting pharmaceutical product safety updates to the FDA concerning serious risks as soon as possible expedites the dissemination of life saving information to the general population. Furthermore, depending on the frequency and seriousness of the adverse effects, the FDA might demand the pharmaceutical product's distribution be restricted or pulled off the market altogether. That said, the FDA typically allows the product to continue being sold if the public health benefit of the product outweighs its known risks. Often, as more becomes known about the potential risks or benefits of a pharmaceutical product, its label is revised to better reflect information on adverse reactions not previously listed, to add new warnings describing conditions under which the drug should not be used or to add new precautions advising doctors of measures to minimize drug use risk.