Clinical Trial Disclosure Efficiency in Five Steps

Science has authority, not because of white coats, or titles, but because of precision and transparency: you explain your theory, set out your evidence, and reference the studies that support your case.

-Ben Goldacre

The complexity of working with evolving global health authority requirements on clinical trial disclosure can be significant. The World Health Organization’s statement published on April 14, 2015, defines timeframes for reporting clinical trial results. The Food and Drug Administration Amendments Act (FDAAA) 2007 requires sponsors to register ongoing clinical trials and to report the results of completed clinical trials within certain timeframes on ClinicalTrials.gov. EU regulation Policy 70 mandates public disclosure of clinical trials in an EU public database. Aside from these major regulations, many countries worldwide have their own regulations on clinical trial disclosure. In some countries, there is more than one registry or database for this purpose. We can see that the field of clinical trial disclosure is fluid and being shaped as we speak.

At present, sponsors of multinational clinical trials must coordinate clinical trial disclosure according to international and national guidelines. Challenges of disclosure include collecting data from various sources, data validation, registry input, process tracking, prevention of redundancies in multiregistry postings, and maintaining timelines per each registry.

As the field is still evolving, the international and national regulations will overlap, and redundancies are expected for some period of time. It is vital to achieve an integral process designed purposely to minimize the risk of inconsistent data and noncompliance. Whether you opt for an automated software system or choose to input manually, the following five-step process will help minimize error and optimize efficiency.

1. Plan – A gap analysis should be performed to determine which registries are applicable. Careful detailing of requirements such as initial registration, status update frequency (e.g., enrollment status), and results disclosure is necessary. Remember—failing to plan is planning to fail.
2. Collect – Import as many data points from source material as possible. Also, be aware of registry requirements when transcribing for the general public and translating to local languages. To this end, registry-specific datasets need to be generated from the data sources and consolidated per registry specifications.
3. Validate – Before submitting the collected and consolidated data, a quality check should take place to validate the data against registry-specific validation rules and company-specific edit checks. Registries such as ClinicalTrials.gov or EudraCT have a number of edit checks. Make use of these to ensure clean data is submitted.
4. Upload – At this point, the data is ready to be submitted to the registries. Check if the registry supports automatic entry or if manual entry of the data is required. If the registry supports XML files, automatic entry is fairly simple. However, if the registry requires manual data entry, a report showing the data in the same order required by the registry will make for easy copy and paste.
5. Track – Keep track of the status of each registration and know what upcoming steps require action. Address overdue registrations, registry feedback, and outstanding comments.  

Following these five key steps can make disclosure easier. In addition, we recommend developing a toolkit updated routinely with regulatory updates to aid the entire process. This toolkit should include:

1. Standard operating procedures (SOPs) and good practice guidelines for clinical trial registration and results postings to registries.
2. Process flowcharts to map your company’s disclosure process.
3. A roles and responsibilities matrix to assign each task to specific individuals.
4. Process checklists for each step in the SOPs (e.g., trial registration, information updates, results disclosure).
5. Self-training and Q&A materials: SOPs, checklists, and useful links to key regulatory and government publications related to transparency and disclosure commitments.

The five-step process in combination with this toolkit will help to ensure compliance with global clinical trial registries, maintain consistent data across all applicable registries, and ultimately achieve the goal of clinical trial disclosure and transparency.

Contact us at medicalwriting@transperfect.com for more information on establishing your clinical trial disclosure processes and best practices.