Re: Docket No. FDA-2016-D-1224: Use of Electronic Health Record Data in Clinical Investigations
The Biotechnology Innovation Organization (BIO) thanks the Food and Drug Administration (FDA) for the opportunity to submit comments on the Draft Guidance entitled “Use of Health Record Data in Clinical Investigations” (Draft Guidance).
BIO is the world's largest trade association representing biotechnology companies, academic institutions, state biotechnology centers and related organizations across the United States and in more than 30 other nations. BIO members are involved in the research and development of innovative healthcare, agricultural, industrial, and environmental biotechnology products.
Electronic health record (EHR) data and “real world evidence” generated from the post-marketing clinical use of medicines can provide valuable information regarding the use, benefits, or risks of therapies. BIO applauds FDA for taking steps to provide greater clarity around the use of EHR data in clinical assessments of safety and effectiveness in regulatory submissions.
In general, the Draft Guidance is helpful and well-constructed, providing useful information to assist sponsors in incorporating and integrating EHR data into FDA-regulated clinical investigations.
As the Draft Guidance notes, EHR systems are generally not under the control of FDA-regulated parties, which presents numerous operational challenges as FDA seeks to assess and ensure the validity, reliability, and integrity of data originally generated by non-FDA regulated parties. To that end, BIO requests additional clarification regarding the responsibilities of the sponsor and how the Agency intends to uphold EHR data standards through on-site inspections and audits. Additionally, the draft guidance should acknowledge the EHR responsibilities of the PI (and of the associated organization/institution) making clear distinctions between the Sponsor and PI.
Similarly, it would be very helpful to have additional clarity related to a sponsor’s responsibilities regarding extracted data; for example, what checks might be necessary when data is transferred to the sponsor’s system, and whether sponsors could extract data ready for analysis on a server without entering it into a structured database (such as an electronic data capture (EDC) system).
As indicated in the below chart, there are a number of other topics on which further detail would be helpful, such as the assessment of ex-US electronic health record data, as well as practical implementation of some of the recommendations in the Draft Guidance.
In addition, we suggest that FDA provide additional guidance related to the use of clinical notes; as well as confidentiality, use, and interpretation of non-structured data in clinical investigations. Sponsors would also benefit from clarification regarding the Agency’s position on de-identified data, and how it affects any applicable privacy requirements.
Lastly, we recommend that FDA consider an initiative to better align data standards between EHRs and clinical trial submissions. EHRs are encouraged to follow applicable Health Level 7 (HL7) standards, yet clinical trial submissions generally adhere to Clinical Data Interchange Standards Consortium (CDISC) standards. Greater alignment between these sets of standards would foster greater consistency and facilitate interoperability.