By Sarianne Gruber
Twitter: @subtleimpact
The health industry has begun to feel the effects of heightened transparency as consumers, physicians, insurers, pharma and life sciences companies and others become armed with more data. Last year, the US Department of Health and Human Services proposed new rules that would require clinical trial sponsors to report the summary results of all clinical trials, not just trials that receive FDA approval. Historically, many clinical trial datasets are never published limiting researchers from valuable information. As of October 2014, 520 organizations, including physician groups, patient advocated, government regulatory bodies and one large pharmaceutical company, GlaxoSmithKline, had signed the AllTrials petition, which calls for “all trials registered, all results reported.”
Financial Times July 2015
Ben Goldacre, co-founder of AllTrails and author of the book Bed Pharma claims the industry was split between those “showing leadership on transparency” and others that were” stuck in the past”. Dr. Goldacre said, ” Companies cannot expect any longer to routinely withhold the results of clinical trials on treatments taken by millions of people around the world. These investment firms are showing clearly that they will reward good data and best practice.” To open the results of clinical trials to public scrutiny is gathering momentum. Last week 85 institutional investors threw their weight behind activists demanding more transparency in pharmaceutical research; this week 50 patient and medical organisations in the US will add their voices to international AllTrials campaign.
The US Food and Drug Administration (FDA) along with the National Institutes of Health (NIH) are also addressing the need for improved transparency and disclosure. The OpenFDA initiative, launched in 2014, provides a public database for analyzing drug and medical device adverse events, recalls and labeling information. Patients and physicians can search the data sets to examine the real-word frequency of side effects with specific products. OpenFDA‘s adverse events database has over 4 million records from 2004 to 2013. The NIH maintains the largest database for sharing clinical trial summary results with patients and the medical community. In addition, the FDA is encouraging development of third-party mobile apps to connect patients taking the same medicines, so they can share health experiences.
Ten Open Data Benefits
- Ability to quickly highlight problems with currently used medicines
- Permits R&D programs to focus on new product attributes that will be meaningful to patients
- Clinical trial data provides the ability to better understand disease pathways and progression in specific patient populations, identify biomarkers, conduct smaller, more focused trials and avoid past mistakes
- Increase of data-sharing capabilities with less risk; combine datasets for more insights and better product development
- Large pharmaceutical and medical device manufacturers are contributing clinical trial data sets
- Previously closed clinical trial data sets are now open to university-affiliated researcher
- Contract research organization are using newly-available clinical trial data to design better trials based on learning’s from similar drug testing
- Unnecessary repetition of research and making existing data available for reanalysis and innovation.
- The clinical openness reduces risk and increases investor confidence
- Open data will benefit all, from patients to shareholders, and will increase trust between the public and the industry
Pharmacy Industry Mixed Response
GlaxoSmithKline is the front runner on the campaign to transparency. They have published all current trial results and have plans to release data from their old trials. Johnson & Johnson and Bristol-Myers Squibb are complying with the data emancipation as well. Several other drug companies are reluctant and insist that a commitment to full publication could undermine commercial confidentiality. For more companies to abide by the new rules, legislators and regulators must also take clinical trial transparency more seriously. And so far the FDA has failed to fine companies that do not report results within a year of the trial’s completion.
On an International Level
The World Health Organization (WHO) announced that researchers have an ethical duty to report all clinical trial results, including those of unpublished past studies. The WHO has established an International Clinical Trial Registry platform, which contains prospective trial registration data. The goal is to improve research transparency and ultimately strengthen the validity and value of the scientific evidence base.
Upcoming Development Innovate Advance (DIA) Conference
DIA will host its conference on Clinical Trial Disclosure and Data Transparency this fall. The scheduled dates are September 17 and 18 at the Hyatt Regency in Bethesda, Maryland.
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