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The pharma/biotech/medical device industry has gone through a lot of scrutiny for not disclosing clinical trial data to the public and sometimes been accused of hiding information when there were questions about product safety.
The purpose of opening clinical trial data ideally is to share information in order to avoid duplication of trials, or repeating mistakes. It is also useful to bring another set of eyes, or different perspectives to drug research so that we might better understand diseases, or create a research models from other scientific viewpoints, including physics, plain computer science, mathematics, and even non-science disciplines.
There have been examples where computer science people with no life sciences background have solved scientific problems in modeling, or where biologists are working with engineers in research at the Koch Institute in Cambridge, MA.
The British Medical Journal (BMJ) stated that beginning in 2013, "they will only publish studies on drugs and devices, whether industry funded or not, where there is a commitment to "make the relevant anonymised patient level data available on reasonable request." GSK already started posting their trials on their website. Patrick Vallance, the president of pharmaceuticals R&D at GSK, said, "Moves like this should help medical research by allowing scientists to study the detailed results of clinical trials and increase understanding of current and new medicines."
However, like everything else, there are concerns around opening clinical trials data to the public or other researchers:
Issue one is ensuring patient privacy - although most clinical trials try to keep the patient information confidential, there is human error. Recently, Medtronic misplaced a box of patient medical records relating to the use of its insulin pumps and continuous glucose monitoring devices, and it contained confidential information affecting more than 2,500 patients. If these patient records were electronic, there would have to be protocols and a system to ensure that no one has access to this information or that no one could mistakenly send this information without double checks.
If patients are not assigned a number for a clinical trial and all data is referenced to that designated number, confidential information could mistakenly identify the patient. All trials would have to be set up the same way, to ensure consistency in software applications when inputting and accessing data.
Issue two concerns access to proprietary information - some companies feel that giving access to clinical trials would only benefit their competitors. While Roche and GSK have already committed themselves to opening up their clinical trials to the public, AbbVie and InterMune won at least a temporary reprieve in their fight to stop the EMA from releasing trial data on their drugs.
However, The European Federation of Pharmaceutical Industries and Associations (EFPIA), although in favor of transparency, cautioned that striving for full disclosure of trial data could potentially cause "significant harm to the interests of innovators and individuals if transparency is approached in an indiscriminate way." The EFPIA also cautioned that in addition to personal privacy, commercial confidentiality must be taken into account considering the number of products and new uses that are not protected by patents.
Issue three is finding independent experts to manage the access of clinical trials for everyone in the industry. "We are the first organization to develop a system for sharing detailed clinical data in this way," said GSK's Patrick Vallance. "We are keen for this to progress and hope such a system can be put in place by a third party in the public or charitable sector as soon as possible."
The program will be managed by a group of "independent experts," including Brian Strom at the University of Pennsylvania, Marc Buyse at Hasselt University Belgium and Bartha Maria Knoppers at McGill University in Canada. However, it's difficult to find completely independent experts in this industry, as many are consulted for their clinical and scientific expertise. "Strom, for example, received at least one $5,500 payment to consult for GSK, according to ProPublica's database." said Vallance.
In the latter part of February, "Roche announced that it is expanding access to its clinical trial data for third party researchers. Roche will work with an independent body of recognised experts to evaluate and approve requests to access anonymised patient-level data. Roche will support the release of full clinical study reports (CSRs) for all its licensed medicines via regulatory authorities and make available any CSRs that cannot be provided by these authorities upon a researcher's request."
Issue four is a unified approach to transparency of clinical trial data with all countries' agencies. Major pharmaceutical and biotechnology companies such as AbbVie, AstraZeneca Pharmaceuticals LP, BiogenIdec, Bristol-Myers Squibb, EMD Serono, GlaxoSmithKline, etc., who are in favor of sharing data but have reservations on the above issues have "congratulated the Institute of Medicine (IOM) for their leadership in planning a consensus study later this year on the topic of sharing clinical trial data. The study will focus on making recommendations for responsibly sharing clinical trial data. Input will be drawn from a broad range of stakeholders, including academic institutions, private industry, patient advocacy, non-profit organizations, medical journals, health care providers, government, and international regulatory agencies."
"The industry members will work in collaboration with the IOM and other study sponsors to develop a statement of task focused on the "who, what, when and how" of data sharing, including a governance framework that addresses concerns relating to patient privacy, confidential information and scientific integrity."
The UK has also followed suit in putting unified protocols or processes in place for those wanting access to clinical trials. The Association of the British Pharmaceutical Industry (ABPI) and the Royal College of Physicians (RCP), the Ethical Standards in Health and Life Sciences Group (ESHLSG) launched Clinical Trial Transparency Principles and Facts at the ABPI and British Medical Journal's joint conference on innovation in research.
"According to the ESHLSG, this is the first time that leading healthcare professional bodies and senior representatives of the pharmaceutical industry have agreed to a joint approach to tackle the issue, and say the move is an "important step forward" in driving best practice in clinical research reporting."
"The guidelines include a 21 day limit for investigators to publish methods and plans for a clinical study on a publically accessible register once patient enrollment has begun, and that in commercial pharmaceutical trials, investigators should make available the methods and results of their trial within one year of the product gaining market authorisation."
"In addition, if the product fails to gain market authorisation, but the results are of significant medical importance, researchers should make those results available within a year of completion of the trial in a publicly accessible website or journal."
The outcome of all of this was summed up nicely by the EFPIA that stated, "Medicines should benefit patients. We support measures that enhance the way they are used and enable the industry to continue to innovate. These measures include improved transparency. As a global industry, we are focused on working towards responsible transparency, as shown by the commitments already made. Building on these initiatives, we recognise and take seriously our responsibility to lead in advancing transparency, and propose that this needs to be part of a comprehensive initiative involving all stakeholders."
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