Jennifer E. Miller, PhD, assistant professor, NYU School of Medicine, founded Bioethics International in 2005 with the goal of improving trustworthiness and patient-centricity in the pharmaceutical industry.
As part of this, the organization launched the Good Pharma Scorecard in 2015.
“The reason we started the Good Pharma Scorecard is because of the ethics, trustworthiness, and patient centricity concerns surrounding the pharmaceutical industry,” said Dr. Jennifer E. Miller, founder of Bioethics International (BEI).
The Good Pharma Scorecard ranks companies on clinical trial transparency and data-sharing performance. In the future, the Scorecard will also evaluate clinical trial design integrity, the accessibility of medicines, drug marketing practices, and other ethical issues.
“Only 10% of Americans trust that pharmaceutical companies are honest and ethical,” Miller told Outsourcing-Pharma.com. “91% of people think companies put profits before people.”
Yet, it doesn’t have to be this way, she said. “So, we developed a set of standards that represent a ‘good pharma company,’” which BEI defines as ethical, patient-centered, and trustworthy.
Five companies made it onto the Good Pharma Scorecard leaderboard, including Johnson & Johnson (J&J) and Sanofi, which tied for first, followed by Abbvie, Cellgene, and Merck.
Sanofi was also the most improved company this year, Miller explained, adding that overall, the organization has seen improvements since the first pilot scorecard was released two years ago.
“I think it really shows what gets measured gets done,” said Miller.
Measuring up
In 2014, the US Food and Drug Administration (FDA) approved 19 novel new drugs, sponsored by 11 large companies, involving 553 trials.
For the 2017 Scorecard, Bioethics International analyzed 505 of these trials and found that per drug, a median of 100% of trials in patients were registered, 71% reported results or shared a clinical study report (CSR) synopsis and 80% were published.
Additionally, 96% were publicly available in some form 13 months after FDA approval, compared to the 2015 report – which measured new molecular entities approved in 2012 – in which 87% of the trials were publicly available. “That was a huge jump,” said Miller.
“The other huge jump is that when we looked at the drugs that were approved in 2015, half of all the drugs reviewed … had an undisclosed Phase II or Phase III trial 13 months after FDA approval,” she added. This year, 70% of all the drugs reviewed had all their Phase II and III trials disclosed.
According to the report, disclosure rates were lower at FDA approval (65%) but improved by six months post-FDA approval.
However, only half of the FDA-approved drugs publicly disclosed results for all trials in patients included in the sample. “On the company level, about 18% of large companies fully disclosed all such results and complied with FDAAA disclosure requirements,” according to the report.
Trending towards transparency
Several organizations have been voicing the idea of open trials and calling for full transparency in the industry, and with each group joining the movement gets “more oomph,” said Miller.
“The industry has been trending towards greater openness very slowly,” she explained, noting that BEI introduced accountability for the first time to track progress and incentivize better performance when needed.
“I hope that we see continued improvement on all of the transparency metrics,” Miller said.
Next year, the 2018 scorecard will have more metrics, adding the standard that companies should share patient-level data from trials.
“For the last two scorecards we only looked at whether summary results were posted or whether the trial was published in the medical literature,” Miller explained. “Now we're saying, you shouldn’t just register, report, and publish your trials, you should also share the data from the trials.”
The organization will also shorten the timeframe of measurement from 13 months post-FDA approval to six months.
In 2018, Miller hopes to see companies score well on the patient-level data sharing standards. “I hope to see more data getting out there and getting out there more quickly,” she said.
Author: Miller JE, Wilenzick M, Ritcey N, et al
Publication: BMJ Open 2017
Date: 5 December 2017
DOI: 10.1136/bmjopen-2017-017917