4 Dos And Don’ts Of Clinical Trial Submissions
Clinical trial submission is submitting documents to the regulatory authority to get approval for a new drug or medical device. It’s a critical step in the development process and requires careful planning, precise documentation, and strict adherence to regulations. The data submission process ensures that the data collected is valid and reliable. With proper submission, the results can be approved and made public and achieve successful marketing authorization.
However, submitting a clinical trial for approval can be complex, with numerous regulations and guidelines to follow. To ensure that the trial is conducted ethically and safely, it’s crucial to understand the dos and don’ts of clinical trial submissions. This includes understanding the documentation, format, and information required. Here’s a detailed look into the dos and don’ts of submitting clinical studies.
Dos Of Clinical Studies Submission
Regulatory agencies such as the Federal Drug Administration (FDA) and the European Medicines Agency (EMA) have specific requirements for clinical studies. Here are a few dos that need to be followed during submission:
Ensure CDISC Compliance
The Clinical Data Interchange Standards Consortium (CDISC) provides a common data format and standards for submissions that must be adhered to. Pharmaceutical companies and clinical research organizations must comply with CDISC when submitting clinical trial data to the FDA and the Pharmaceuticals and Medical Devices Agency (PMDA). The CDISC Academic compliances and regulations also guide how data is collected, analyzed, and submitted for purposes such as funding.
One of the most common formats required by CDISC is the Standard for Exchange of Non-clinical Data (SEND). This format exchanges non-clinical data, such as laboratory results and other data collected during testing. Another model is the Standard Data Tabulation Model (SDTM), which provides a standardized way to collect study domains for clinical study submission. These domains define the structure and build of data sets.
Include Administration Information
Administration information is essential for the manufacturers and sponsors of the clinical trials. It includes sponsor information, Clinical Trial Agreement (CTA), investigator information, and investigator brochure. These are collected as part of administrative sections to get approval from regulatory agencies.
Include All Scientific Information
The scientific information should be accurate and up-to-date, including protocol details such as objectives and inclusion/exclusion criteria. The scientific information is divided into the following categories:
- Participant Flow: This table overviews the study’s progress. It includes information on how many participants completed the study, withdrew from the study, or were lost to follow-up.
- Demographic And Baseline Data: This information is collected in a table format, including age, sex, ethnicity, and other relevant participant characteristics. It also includes study-specific data such as baseline values for vital signs, lab tests, and other relevant measurements.
- Outcome Measures and Statistical Analyses: This includes the primary and secondary outcome measures and the analysis method. It’s also essential to include information on how missing data was handled in the analyses. If there are any prespecified outcomes or post hoc outcomes during the study, they should also be included.
- Adverse Events: Adverse events should be clearly described and included in the submission. This includes all relevant information on the severity, duration, relationship to the study drug or procedure, and other pertinent details. For each adverse event recorded during the study, information such as the number of participants affected and those at risk, the affected organ, and the comparison arm should be included.
The scientific information should be thorough and complete, as it’s a crucial submission element.
Create A Protocol Registration and Results System (PRS) Account
The Protocol Registration and Results System (PRS) online registers clinical trials with ClinicalTrials.gov. It’s a mandatory requirement for submitting clinical studies. A PRS account should be created before submission, as it allows sponsors and regulatory agencies to track the study’s progress in real-time.
Once you have the PRS account, you can log in and start the submission process. This includes filling out all the required and optional information. For example, you must include the study start date, enrollment, intervention information, and primary and secondary outcomes. Once you have entered all the information, you can submit the clinical trial for review.
Don’ts Of Clinical Trial Submission
It’s common to have questions and doubts, especially at the time of the submission. Here are some don’ts:
Don’t Submit Incomplete Data
It’s essential to include all the necessary information for the submission. This includes participant flow, adverse events, and other relevant data. Incomplete information could lead to a delay or rejection of the clinical trial.
To avoid such cases, you can check the regulatory body requirements guidelines on what information must be included in the submission. For example, using the PRS account helps identify each submission’s requirements.
Don’t Forget Supplemental Qualifiers
Supplemental qualifiers are additional information that can be provided to support the study findings. These include patient characteristics, inclusion/exclusion criteria, treatment protocols, sample sizes, and other pertinent details. The qualifiers contain non-standard variables which the existing SDTM domains can’t represent.
These qualifiers should be included in the submission as they provide additional insight into the study. They also help authorities to evaluate if the study is scientifically valid and whether or not it meets regulatory standards.
Don’t Forget the Documentation
Documentation is one of the critical components, as it helps to explain why and how a particular decision was made during the study. Including sufficient documentation can lead to rejection from regulatory agencies. Good documentation practices include submitting protocol documents, investigator brochures, case report forms, clinical reports, statistical analysis plans, summary tables, and other relevant documents.
It’s essential to follow the guidelines of regulatory bodies to ensure a successful submission. Following these dos and don’ts can help ensure your submission is complete and accurate.
Don’t Forget Quality Control (QC) Checks
Quality control checks help to ensure that the data is accurate and complete before submission. This includes checking for errors, duplicates, incomplete forms, and other relevant factors. Quality control checks can also help verify discrepancies between the protocol documents and the final study report. Any such discrepancies should be addressed before submission.
Submitting a clinical trial can be challenging for any research organization. It requires extensive planning and preparation to ensure the submission meets all regulatory requirements. By following the dos and don’ts outlined in this article, sponsors can maximize their chances of getting approval for their clinical trials. Remember that regulatory authorities constantly update guidelines, so staying up-to-date with the latest requirements is essential.