Contributing factors to the noted lack of compliance and the disclosure of inconsistent data are myriad. The guidances supporting the laws and regulations are vague, and it is not always clear which data need to be reported and in what format data should be disclosed. Many companies do not have a dedicated clinical trial disclosure or transparency department to navigate the regulations, nor do they have the resources to dedicate to full-time data disclosure.
Moreover, despite the penalties and fines for lack of compliance that have been written into the law, the National Institutes of Health is not, at present, enforcing the rules and enacting penalties. Thus, there is little incentive to comply with the law.
In an effort to incentivize researchers to increase data transparency across pharmaceutical companies, authors of the study are releasing an annual “Good Pharma Scorecard,” which will rank pharmaceutical companies based on adherence to the following critical elements, among others, of data transparency:
- Public registration of applicable clinical trials
- Disclosure of results data after market approval of the product under study
Study authors looked at publicly available data “for all drugs approved by the FDA in 2012 that were sponsored by the 20 pharmaceutical companies with the highest market value.” Of the 48 new drug entities approved in 2012, 15 were sponsored by 10 large pharmaceutical or biotechnology companies with market value over $19 billion. A total of 318 trials involving approximately 100,000 participants were conducted to support the market approval of these 15 approved drugs.
The findings from the study are consistent with findings from external audits periodically conducted by independent “watch-dog” groups on the pharmaceutical industry. Researchers found that:
- Almost 50% of the reviewed drugs had at least one undisclosed Phase II or III trial associated with the drug;
- For each drug, only 57% of trials were properly registered;
- 80% of applicable clinical trial results summaries were not disclosed to ClinicalTrials.gov;
- 65% of trials had meaningfully published results;
- 56% of trials had results published in academic/scientific journals;
- Compliance varied widely among companies; 2 of the 10 companies under study disclosed all trials
These findings highlight undisclosed protocols, results, and publications which would indicate a problem with properly tracking workflow, alongside of issues pertaining to the lack of quality in the summarization of data. Solutions to these issues exist in the marketplace to navigate organizations around such operational pitfalls.
Software solutions may allow users “data reuse” capabilities so initial entry of clinical trial information can be repurposed for reporting to any country with mandatory clinical trial disclosure laws worldwide. These systems can track workflow of registries, and also comply with transparency requirements for lay summaries, publications, redacted documents and data sharing. Most importantly, such systems can increase compliance with regulations.
Use of CROs for staff augmentation or by leveraging specialized tools can address internal gaps in expertise or process within pharma, with some vendor organizations having the capacity to serve as a pharmaceutical company’s centralized clinical trial disclosure department.