September 12, 2023
In the ever-evolving landscape of clinical trials disclosure, navigating the intricacies of registration, compliance, and ethical transparency has become more crucial than ever. Pharmaceutical and medical device companies must not only adhere to regulatory guidelines, but they must also balance this against the growing need to ensure transparency and protect sensitive information.
In this blog post, our clinical trial experts share insights on some of the most frequently asked questions in the clinical trials disclosure space including topics such as public registration of clinical trials, mandatory compliance fields, timely disclosure of trial results, and the ethical considerations of data sharing.
This is often one of our most asked questions. If you are planning to conduct a clinical trial (for either a drug, biologic, or medical device), knowing and understanding which trials are required by law to be registered on a public registry (and to which registry) and which ones are voluntary is crucial. Especially if you want to avoid potential monetary fines.
The public registry in the United States is ClinicalTrials.gov, which defines this as an 'Applicable Clinical Trial' or ACT. An ACT is a clinical trial that studies a drug, biologic, or device product and meets all the following criteria:
If you are still not sure if your trial meets the definition of an ACT, the NIH has developed a checklist that can be leveraged. Once you have determined if you will register your clinical trial (whether per the requirement or voluntarily), you are then obligated to follow the legislation/guidelines that dictate what information must be presented and how often it needs to be updated.
There could be several drivers behind public registration of a clinical trial, such as corporate transparency policies or regulatory authority commitments. Another compelling reason would be the desire to publish clinical trial results in a journal. Even if a clinical trial is not considered an ACT by definition, the International Committee of Medical Journal Editors (ICMJE) Guidelines recommend that medical journal editors require the registration of clinical trials in a public trial registry (any WHO International Clinical Trials Registry Platform [ICTRP] is acceptable) at or before the time of first patient enrollment. The ICMJE will use the date the trial registration materials were first submitted to the registry as the date of registration and registrations posted retrospectively will not qualify. In addition, not only is registration required, but ICMJE also requires that the Sponsor's include their data sharing plan in the registration.
Thus, it could be helpful to include the potential publishing of study results in the decision tree when considering whether or not to register a clinical trial.
Yes! There are 14 fields on the ClinicalTrials.gov public registry that have ongoing compliance requirements, which means that those fields must be updated within 15 or 30 calendar days of the change occurring (not when you become aware of the change). In addition, protocol amendments that impact any information on the registry must be incorporated within 30 calendar days.
Registry fields with mandatory compliance include:
Once the clinical trial has been successfully registered, it is best practice to set up a monthly review cycle to identify any changes in the above fields to ensure continued compliance throughout the clinical conduct of the study.
For ACTs, results for all identified primary and secondary endpoints must be disclosed on ClinicalTrials.gov within 1 year of the primary completion date (last patient, last visit for the specified outcomes). Identified means anything labeled in the clinical trial protocol or statistical analysis plan as a primary or secondary endpoint; exploratory endpoints or endpoints labeled as other are not required to be disclosed.
An important thing to keep in mind is that regardless of clinical trial outcome and/or overall study completion (terminated, completed), if the data were collected, legislation (FDAAA Section 801) requires that the data are reported. So even if a study is terminated, if data were collected (whether there is a plan to analyze the data or not), the NIH has NOT in the past (in our experience) accepted that data 'were not analyzed'. The only acceptable reason (to the NIH) for not reporting results is if NO data were collected.
Yes, Sponsors are now required to upload a final version of the clinical trial protocol and/or statistical analysis plan with their results on ClinicalTrials.gov for ACTs. Even for voluntary studies, if the decision is made to post the results of the clinical trial, then all applicable legislation/guidelines must be followed, including posting of these files.
This needs to be the FULL version of the protocol, not a synopsis, which can bring up not only personal, but also commercial data privacy concerns, so consideration may need to be made for masking or redacting information in the documents (including building this into your timeline and review). Another question we hear often is, what information and how much should be redacted? Clinical trial Sponsors must balance the need to meet global legislative requirements and the need to protect not only personally protected data (PPD), but also company confidential information (CCI). In addition, if the protocol will be made public via multiple channels (EMA, Health Canada), you will want to ensure consistency in redactions across platforms. There are multiple guidelines and tools for Sponsors to use as they navigate the redaction of both PPD and CCI information in documents depending on the regulatory purpose.
The Good Pharma Scorecard (Bioethics International) uses multiple factors, including transparency and data sharing practices to rank companies on their bioethics and social responsibility performance.
For transparency and data sharing, they look at what companies are obligated (by law) to report on and if they completed those activities on time, specifically:
They also look at the following with respect to a company's data sharing policies:
This is just one area that contributes to the overall score. How would your company rate on the above? You can check out this link to see if your company is on the scorecard and where they rank.
Conducting clinical trials means navigating a myriad of legislative requirements across potentially multiple countries, to first understand and then to comply. In today's highly regulated and ethically driven landscape of clinical trials, staying informed with clinical trials disclosure guidelines and requirements is paramount.
Planning for all the potential and future disclosures and transparency needs can be daunting. Do you need help deciphering the regulations? Not sure if you need to report the results of your clinical trial or how to do it? Have questions about what should or should not be disclosed? ProPharma can help you navigate the ever-evolving regulatory landscape, not only in the United States, but globally, with a flexible and agile team of trusted clinical trials disclosure experts.
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