Recently the Department of Health and Human Service (HHS) issued a final rule specifying more expansive rules and stiffer penalties for those who conduct clinical trials, requiring the registration of certain clinical trials and submitting summary results information to ClinicalTrials.gov. The ruling will apply to FDA-regulated drugs, biologicals and devices, and will become effective on January 1, 2017.
According to the ruling posted in the Federal Register,
This final rule does not impose requirements on the design or conduct of clinical trials or
on the data that must be collected during clinical trials. Instead it specifies how data that were
collected and analyzed in accordance with a clinical trial’s protocol are submitted to
ClinicalTrials.gov. No patient-specific data are required to be submitted by this rule or by the
law this rule is intended to implement.
The sponsor, typically the pharmaceutical company, will be responsible for submitting the data. The rules expand the studies that must be registered, including Phase 1 drug trials that have NIH funding and those trials that include behavioral aspects, like specific study-design diets.
The new ruling is an attempt to give healthcare providers and potential trial subjects more information regarding their medical decisions and whether or not to consider a trial. In addition, HHS hopes the increased information will prevent redundant trials.
According to the NIH, the most important aspects of the final rule are:
What will that mean for pharmaceutical companies?
- Providing a checklist for evaluating which clinical trials are subject to the regulations and who is responsible for submitting required information;
- Expanding the scope of trials for which summary results information must be submitted to include trials involving FDA-regulated products that have not yet been approved, licensed, or cleared by the FDA;
- Requiring additional registration and summary results information data elements to be submitted to ClinicalTrials.gov, including the race and ethnicity of trial participants, if collected, and the full protocol;
- Requiring additional types of adverse event information; and
- Providing a list of potential legal consequences for non-compliance.1
In addition to a daily $10,000 fee imposed if pharmaceutical companies do not comply with the rules, there is a possibility that a future state could include sharing individual patient-level data. With that sharing of patient-level data could eventually come more fields of data like genetic markers, concomitant conditions and concomitant medications.
In addition, registry information will “accurately reflect the prespecified protocol and have accounted for all prespecified outcome measures. This helps to (1) prevent the type of incomplete results reporting that has been documented in conference and journal abstracts, as well as in full journal articles [Ref. 33] and (2) allow the members of the public to assess fidelity to the protocol, which is essential to understanding the validity of disclosed results3
According to an article entitled Toward a New Era of Trust and Transparency in Clinical Trials, published in the JAMA, “Fundamental changes are needed to reflect science and society’s movement to increase efficiency, accountability, and transparency in clinical research2
Oncology practices have available the resources from IntrinsiQ Specialty Solutions and ION Solutions to become study sites that can easily complete the reporting requirements necessary for the sponsor. In addition, IntrinsiQ Specialty Solutions can provide opportunities for analytics on potential study subject populations.
- https://www.nih.gov/news-events/news-releases/hhs-take-steps-provide-more-information-about-clinical-trials-public Page 24