Pfizer Inc. (NYSE:PFE) on Wednesday detailed how it updated access to clinical trial data, making obtaining information more convenient. There will be a data access portal called INSPIIRE, reports will be published online, and the company’s “Blue Button” technology will be available for trial participants.
Freda Lewis-Hall, Pfizer’s executive vice president and chief medical officer, outlined the reasons for the new procedures in a company statement: “Pfizer’s expanded policy is part of a larger and evolving effort by those who create and use clinical data to arrive at a transparent, harmonized process to expand access in ways that protect patient privacy, respect the regulatory process and maintain incentives to conduct new research.”
The upgrades were also needed to meet standards established by Pharmaceutical Research and Manufacturers of America (PhRMA) and the European Federation of Pharmaceutical Industries and Associations. In July, the organizations set out five commitments biopharmaceutical companies needed to adopt by January 1.
Broadly, the guidelines are: 1. Enhancing data sharing with researchers; 2. Enhancing public access to clinical study information; 3. Sharing results with patients who participate in clinical trials; 4. Certifying procedures for sharing clinical trial information; and 5. Reaffirming commitments to publish clinical trial results. All patient data will be anonymous.
Pfizer said that its INSPIIRE public Web portal is a way for researchers to request access to patient data from Pfizer trials that have been published on clinicaltrials.gov and complete for 24 months. A review panel will look over any request that has not been fully granted by Pfizer.
This complies with the first point that biopharmaceutical companies needed to comply with: providing data to further research. The review board was mandated, along with patient identity confidentiality safeguards.
Overviews of clinical study reports will be added to Pfizer’s website regarding approved products. Plain-English results from clinical trials will be available to trial participants, should they desire the information. The Blue Button lets people who participated in trials download the data that pertained to them during the trial, according to Pfizer.
The clinical study reports were another point mentioned specifically in principles. The synopses of the reports are the minimum threshold allowed for helping professionals and patients understand the trials. The non-technical version of the report and Blue Button align with the third point, that patients need to be better informed about the trials they partook in.
In increasing the availability of clinical trial data, Pfizer says it is reaffirming practices already in place, such as publishing “manuscripts for all interventional clinical trials in patients, regardless of outcomes,” 18 months after completion.
All published information helps to achieve compliance with the fourth and fifth points.
GlaxoSmithKline (NYSE:GSK) has also launched a website aimed at conforming with the standards established. Glaxo’s website went live in May and will be updated ahead of the January 1 deadline. PhRMA acknowledged both Pfizer and GlaxoSmithKline’s efforts to implement the measures, which serve to enhance transparency and scientific research.