August 23rd, 2017 How Data Transparency In Clinical Trials Would Improve Patient Recruitment Improving patient enrollment in clinical trials may depend on greater data transparency within the healthcare industry. The conversation – or argument – surrounding data transparency in clinical trials is as old as the process of clinical research itself. However, this past decade has seen a growing demand for easier access to a wider variety of clinical trial data, including information on methods, results, side effects, and patient populations. But it’s not just researchers and major clinical trial sponsors who are hungry for that data – patients are requesting better transparency as well. The age of consumer empowerment has had a transformative impact on the healthcare industry. Today, patients are going online, conducting their own research, and making their own decisions about treatment. This represents an opportunity for clinical trials to mitigate the negative impact of one of its longest-standing pain points: patient recruitment. Today, nearly 30% of a given clinical trial’s total expenses can be attributed to patient enrollment and 40% of trials fail to meet their recruitment goals. Much of this problem boils down to a general lack of awareness and trust among target patient populations. Moreover, recent research from Tufts CSDD suggests that less than 0.2% of physicians and nurses actively refer their patients to active studies, primarily because of limited transparency and poor communication on the part of the clinical research community. What’s clear is that better access to relevant data would bolster trust among both patients and physicians, providing the information they need to enroll or refer, respectively. The Challenges of Sharing Data Of course, efforts have been made to regulate data transparency in the past – the Declaration of Helsinki in 1964, the establishment of ClinicalTrials.gov in 1999, and the AllTrials registration and reporting campaign in 2013 were intended to accelerate the pace of medical research and, more relevant to this conversation, fulfill “our fiduciary and ethical responsibilities to human research volunteers,” as Andrew Burrows, writing for KNect365, puts it. Despite all of these regulatory initiatives, about 40% of drug-related clinical trials that ultimately secured FDA approval remain unregistered, and 50% of clinical trial results are never published at all. So why is data transparency so difficult for clinical trials? Obviously, that’s an incredibly complicated question to answer. To name just a few of the contributing factors, there’s the issue of privacy, which remains a major concern for patients, especially if the data is open source and can be analyzed by external parties for any number of reasons; then there’s the FDA’s general reluctance to share data, likely caused by pressure from large pharma, medical device, and biotech sponsors who are afraid their competitors might seize upon “trade secrets,” which “would serve as a disincentive to invest in clinical research and patentable products.” Parties involved in the debate also point to the price tag of developing a secure system designed to “receive and respond to data requests,” which would likely “include the expense of hiring statistical experts, lawyers, and other experts to review the data that is to be released.” That said, if increased data transparency does have the positive impact on patient recruitment that many experts are predicting, that would likely offset many of the costs and potential downsides that would come along with it. As Burrows aptly points out, it will all come down to the framework we construct to ensure trial data is secure and its use remains ethical. That means baking in “some type of oversight with the authority to both make sure that laws are followed as intended,” and that doles out appropriate punishments when they’re not. In the age of consumer empowerment, data transparency is no longer optional. Ultimately, if clinical trials want to see a real improvement in recruitment outcomes, they need to adapt their practices in accordance with evolving patient expectations. It may come at a high cost, but I’d argue that anything is better than the alternative: failure.
Improving patient enrollment in clinical trials may depend on greater data transparency within the healthcare industry. The conversation – or argument – surrounding data transparency in clinical trials is as old as the process of clinical research itself. However, this past decade has seen a growing demand for easier access to a wider variety of clinical trial data, including information on methods, results, side effects, and patient populations. But it’s not just researchers and major clinical trial sponsors who are hungry for that data – patients are requesting better transparency as well. The age of consumer empowerment has had a transformative impact on the healthcare industry. Today, patients are going online, conducting their own research, and making their own decisions about treatment. This represents an opportunity for clinical trials to mitigate the negative impact of one of its longest-standing pain points: patient recruitment. Today, nearly 30% of a given clinical trial’s total expenses can be attributed to patient enrollment and 40% of trials fail to meet their recruitment goals. Much of this problem boils down to a general lack of awareness and trust among target patient populations. Moreover, recent research from Tufts CSDD suggests that less than 0.2% of physicians and nurses actively refer their patients to active studies, primarily because of limited transparency and poor communication on the part of the clinical research community. What’s clear is that better access to relevant data would bolster trust among both patients and physicians, providing the information they need to enroll or refer, respectively. The Challenges of Sharing Data Of course, efforts have been made to regulate data transparency in the past – the Declaration of Helsinki in 1964, the establishment of ClinicalTrials.gov in 1999, and the AllTrials registration and reporting campaign in 2013 were intended to accelerate the pace of medical research and, more relevant to this conversation, fulfill “our fiduciary and ethical responsibilities to human research volunteers,” as Andrew Burrows, writing for KNect365, puts it. Despite all of these regulatory initiatives, about 40% of drug-related clinical trials that ultimately secured FDA approval remain unregistered, and 50% of clinical trial results are never published at all. So why is data transparency so difficult for clinical trials? Obviously, that’s an incredibly complicated question to answer. To name just a few of the contributing factors, there’s the issue of privacy, which remains a major concern for patients, especially if the data is open source and can be analyzed by external parties for any number of reasons; then there’s the FDA’s general reluctance to share data, likely caused by pressure from large pharma, medical device, and biotech sponsors who are afraid their competitors might seize upon “trade secrets,” which “would serve as a disincentive to invest in clinical research and patentable products.” Parties involved in the debate also point to the price tag of developing a secure system designed to “receive and respond to data requests,” which would likely “include the expense of hiring statistical experts, lawyers, and other experts to review the data that is to be released.” That said, if increased data transparency does have the positive impact on patient recruitment that many experts are predicting, that would likely offset many of the costs and potential downsides that would come along with it. As Burrows aptly points out, it will all come down to the framework we construct to ensure trial data is secure and its use remains ethical. That means baking in “some type of oversight with the authority to both make sure that laws are followed as intended,” and that doles out appropriate punishments when they’re not. In the age of consumer empowerment, data transparency is no longer optional. Ultimately, if clinical trials want to see a real improvement in recruitment outcomes, they need to adapt their practices in accordance with evolving patient expectations. It may come at a high cost, but I’d argue that anything is better than the alternative: failure.
