One longstanding issue that has dogged the pharmaceutical industry for decades has been its chequered history in publishing clinical trial (CT) results. For decades now, trial disclosures for new drugs have fallen well short of legal and ethical standards (BMJ Open). Analysts argue that without fully disclosing the results of CTs, the ability of healthcare decision-makers (physicians, prescription guideline writers, et al.) to evaluate the appropriate use of a drug is impaired (DD&D). But more importantly, it's the inaccessible nature of CT results that puts the health and safety of the patient most at risk.
However, in recent times, there's been a concerted push for greater transparency. In Europe, the new EU Regulation, due to take effect next year, will require clinical trials taking place within the EU be registered into an open database. While many countries in Europe are encouraged to register their clinical trials, it is not mandatory. In that regard, the US had already stolen a march on Europe when the FDA Modernisation Act was brought into effect in 1997. At the time, the creation of ClinicalTrials.gov was significant as it would become the world's largest online registry platform. In 2007, the FDA Amendments Act widened the scope of registered studies to include "applied clinical trials", i.e. studies involving drugs and biologics, and medical devices (clinicaltrials.gov).
The clampdown on sponsors to register clinical trials into a public database appears symptomatic of a lack of trust between the public and the pharmaceutical industry. According to the WHO's International Clinical Trials Registry Platform (ICTRP), "[t]he registration of all interventional trials is a scientific, ethical and moral responsibility." So with the FDA and the EMA ramping up efforts to enforce transparency, the pressure on sponsors to adhere to tighter regulations is growing.
Certainly, there is an argument to be had that registering CTs has multiple benefits. For one, it could facilitate patient recruitment (another industry-wide problem) as researchers and participants can single out studies in the pipeline. What's more, registration of clinical trials mean countries can control their research activities more effectively. Considering oversight of early clinical trials in developing countries can at times be lacking, disclosure of all ongoing trials can encourage greater conduct. In the case where clinical trials are abandoned for economical reasons, it is especially critical these trials are registered, as it would inform researchers of the risks associated with new interventions (Watchword).
Furthermore, knowledge of similar or identical trials means researchers can avoid duplication, which experts say could guide the planning of future studies. A public database of CTs could also foster greater collaboration between researchers and healthcare practitioners with both able to identify trials in which they have an interest. Crucially, registries that check data during the registration process can pinpoint trial concerns early on, potentially improving the quality of clinical research (WHO).
But for all the merits of registering clinical trials, in Europe, some analysts question how the new EU regulation will be implemented. One clinical disclosure expert, who spoke on condition of anonymity, acknowledged the new laws as a step forward in rebuilding the trust between the public and the industry. Nevertheless, the expert had misgivings over the kind of information sponsors would make available and whether it could put the identities of patients in jeopardy.
"I'm concerned about the risks associated with making it possible for third parties, or somebody in the public that we don't know, being able to access published data where they could potentially obtain the identities of patients," the expert said.
When asked about what impact the EU Regulation could have on CTs in Europe, the expert admitted it's impossible to know in the short term. While the issue of ensuring the identities of trial participants are safe is a concern, the expert is hopeful things will change for the better.
However, there's a question to be answered over the disclosure of trial results and whether the data available is designed for patients to understand. For that, the clinical expert said more work needs to be done.
"The purpose of these reports," she said, "is to make data available to the authorities so they can assess the safety and the efficacy of the products they want to market. But the data that's available is not really patient-friendly."
While that may be the case, the positives of transparency outweigh the negatives. As more and more CTs taking place across the globe are registered into public databases, the data on record will mean sponsors can be held accountable not only by the patients they're treating, but the public at large.
WHO International Clinical Trials Registry Platform - http://www.who.int/ictrp/en/
Why is Trial Registration so important? - http://www.who.int/ictrp/trial_reg/en/
Clinical trial registration: transparency is the watchword - http://bit.ly/1T3IPai
Drug Discovery & Development - http://bit.ly/1OgxmFc
BMJ Open - http://bit.ly/1ltrflI
The evolution in registration of clinical trials - http://link.springer.com/article/10.1007/s00228-015-1897-9#page-2
FDAAA 801 - https://www.clinicaltrials.gov/ct2/manage-recs/fdaaa