Journals to Require Clinical Trial Data Sharing for Publishing Articles
[Posted on: Thursday, 28 January, 2016] 

Clinical trial transparency has been a contentious issue between sponsors of trials wanting to protect their assets, and the other stakeholders, such as trial participants, demanding increased rapid disclosure. Per the clinical trial disclosure laws written in 2007, all clinical trials must be registered and their data published on clinicaltrials.gov. However, the quality of data published on clinicaltrials.gov web-site leaves a lot to be desired. This week the International Committee of Medical Journal Editors (ICMJE) proposed new rules that would require authors to make all clinical trial data publicly available as a condition for publishing peer-reviewed articles based on that trial. The authors will need to share individual patient data (IPD) underlying all the results included in their articles within 6 months after publication. If authors fail to meet this commitment, the journal may choose to take punitive actions as severe as retracting the publication. These proposed rules are similar to those proposed at other forums. These initiatives, although commendable, rely heavily on the desire of the clinical trial sponsors to voluntarily disclose detailed results of their trials in return for publication, but there are several practical limitations. The main intent of clinical trial data sharing is to expedite the process of developing new therapies for diseases. By helping other developers get useful data and making patients aware of results of the trials they participated in, one can expect reduced unnecessary testing. In effect, by disclosing data from their trials, the sponsors would end up helping their competition. This is the main concern for the sponsors. Sponsors may simply decide to not publish their clinical trial results in medical journals or publish only selected results severely limiting the scope of the data required to be disclosed. Publishing clinical trial results in medical journals is not required for market approval of drugs; it is mostly done to create awareness about a given product. But the risk of disclosure may push developers to use other avenues to create awareness of their products. For public-funded clinical trials or trials funded by non-profit charitable organizations such as the Bill and Melinda Gates Foundation, more data transparency is possible due to the altruistic nature of the sponsors. However, only about 10% of interventional trials are funded through this mechanism. Most of the other 90% trials are funded by for-profit industry making clinical trial data transparency hard to enforce for obvious business reasons. Several pharma companies have voluntarily disclosed selected clinical trial data for the last few years in response to public outcry for increased transparency. But most companies significantly limit the disclosure to non-commercial researchers and to trials where the drugs are already approved and the data published by the owner company first. Similar to our experience from clinicaltrials.gov disclosure of results, voluntary disclosure of results has limitation. The main challenge is avoiding conflict of interest. Companies cannot be expected to disclose full information to competitors. Secondly, providing results of trials to patients creates regulatory concerns. Patients may use the data available publicly to draw conclusions about the merits or risks of a given drug raising concerns about off-label use or promotion of unapproved products. The sponsors may be accused of trying to promote an investigational product. It is important to note that it seems that FDA or other regulators were not a party to the ICJME discussions. Clinical trial data access is an important issue but without considerations of the risk associated with it, any benefit from such access will be tainted. While all agree that there is need for increased transparency in clinical trials, mandating data disclosure may have the opposite effect.