February 26th, 2020 How to Navigate Google’s Crackdown on Clinical Trial Scams Google is taking steps to ensure that users only see ads for reputable clinical trials. Here’s how sponsors and CROs can navigate these new policies. Clinical trials play an important role in advancing medical research. They allow for monitored testing of new drugs and therapies – which can be helpful both for researchers and for patients whose current treatments aren’t proving effective. These trials cover the costs of treatment, and some patients even receive a stipend to reduce the burden of participation. However, in the past few years, researchers have found that a number of stem-cell clinics are using ClinicalTrials.gov – a legitimate clinical research registry run by the National Institute of Health – to promote treatments that charge patients for services that have not been approved by the FDA. These predatory practices have resulted in lawsuits and serious patient harm. Recently, Google began enforcing a new policy that bans ads for “unproven or experimental medical techniques [without] established biomedical or scientific basis.” This includes the majority of stem-cell therapies, gene therapies, and even treatments that show promise but that have “insufficient formal clinical testing” to prove they are effective. While the new policy is certainly a step in the right direction, it may also impact the way legitimate clinical trials use Google for patient outreach. Here’s what sponsors and CROs need to know about fraudulent clinical trials and Google’s efforts to curtail them. How Bad Are Clinical Trial Scams? There have been a number of high-profile clinical trial scams in recent years that underscore the importance of verified, monitored research. For instance, between 2013 and 2016, more than two dozen people on the Caribbean island of St. Kitts and in the state of Illinois were recruited for an experimental herpes treatment. The treatment was designed by professor William Halford of Southern Illinois University – who was not a medical researcher – as part of a so-called clinical trial. Halford’s trial began without a number of essentials: approval from the FDA, approval from the St. Kitts and Nevis government, and written consent from patients to receive injections of live strains of the herpes virus. Halford also administered the injections without the oversight of a physician or nurse practitioner, which is illegal in the U.S. Many of Halford’s patients were desperate and leapt at the chance of a potential cure. However, just one dose brought on a variety of symptoms, including achiness, dizziness, and new outbreaks. While none of the participants had life-threatening responses to the injection, one patient reported experiencing “disequilibrium and slurred speech” that has lasted to the present day. Adverse effects are a risk of testing any new type of treatment, but clinical trials with FDA approval would ideally have safety nets in place to protect patients. Further, unlike many unregulated studies, reputable clinical trials should never ask patients to pay for their own treatment. How Can Clinical Trials Pass Muster? Google’s new efforts to limit the reach of fraudulent trials will likely have wide-ranging effects. On the one hand, reputable studies will no longer have their Google ads displayed alongside those of unlicensed treatments. Yet even sponsors and CROs of legitimate clinical trials may now have to clear a more stringent set of standards in order for their Google ads to reach patients. How Google polices these ads remains to be seen, but it’s a relevant question particularly for FDA-compliant clinical trials that are researching stem cell therapies. There are a few strategies that can go along way, however. Working with patient advocacy groups, for instance, lends credence to clinical trials, and can often help match trials with patients who are well suited for the research goals. Including some version of the phrase “Ask your doctor to contact us” is another surefire way for sponsors and CROs to make their claim for legitimacy, as fraudulent trials will often want to avoid the added scrutiny. Further, digital patient outreach that highlights evidence-based results through informative blog posts and site copy can help establish that clinical trials are not making false claims. For instance, sponsors and CROs testing a new blood pressure medication should be sure to feature patients’ past successes with the treatment prominently on their website, as well as address common concerns patients may have about the drug. With these measures, reputable clinical trials can affirm their credibility as well as distinguish themselves from the experimental treatments that have taken advantage of patients in the past.
Google is taking steps to ensure that users only see ads for reputable clinical trials. Here’s how sponsors and CROs can navigate these new policies. Clinical trials play an important role in advancing medical research. They allow for monitored testing of new drugs and therapies – which can be helpful both for researchers and for patients whose current treatments aren’t proving effective. These trials cover the costs of treatment, and some patients even receive a stipend to reduce the burden of participation. However, in the past few years, researchers have found that a number of stem-cell clinics are using ClinicalTrials.gov – a legitimate clinical research registry run by the National Institute of Health – to promote treatments that charge patients for services that have not been approved by the FDA. These predatory practices have resulted in lawsuits and serious patient harm. Recently, Google began enforcing a new policy that bans ads for “unproven or experimental medical techniques [without] established biomedical or scientific basis.” This includes the majority of stem-cell therapies, gene therapies, and even treatments that show promise but that have “insufficient formal clinical testing” to prove they are effective. While the new policy is certainly a step in the right direction, it may also impact the way legitimate clinical trials use Google for patient outreach. Here’s what sponsors and CROs need to know about fraudulent clinical trials and Google’s efforts to curtail them. How Bad Are Clinical Trial Scams? There have been a number of high-profile clinical trial scams in recent years that underscore the importance of verified, monitored research. For instance, between 2013 and 2016, more than two dozen people on the Caribbean island of St. Kitts and in the state of Illinois were recruited for an experimental herpes treatment. The treatment was designed by professor William Halford of Southern Illinois University – who was not a medical researcher – as part of a so-called clinical trial. Halford’s trial began without a number of essentials: approval from the FDA, approval from the St. Kitts and Nevis government, and written consent from patients to receive injections of live strains of the herpes virus. Halford also administered the injections without the oversight of a physician or nurse practitioner, which is illegal in the U.S. Many of Halford’s patients were desperate and leapt at the chance of a potential cure. However, just one dose brought on a variety of symptoms, including achiness, dizziness, and new outbreaks. While none of the participants had life-threatening responses to the injection, one patient reported experiencing “disequilibrium and slurred speech” that has lasted to the present day. Adverse effects are a risk of testing any new type of treatment, but clinical trials with FDA approval would ideally have safety nets in place to protect patients. Further, unlike many unregulated studies, reputable clinical trials should never ask patients to pay for their own treatment. How Can Clinical Trials Pass Muster? Google’s new efforts to limit the reach of fraudulent trials will likely have wide-ranging effects. On the one hand, reputable studies will no longer have their Google ads displayed alongside those of unlicensed treatments. Yet even sponsors and CROs of legitimate clinical trials may now have to clear a more stringent set of standards in order for their Google ads to reach patients. How Google polices these ads remains to be seen, but it’s a relevant question particularly for FDA-compliant clinical trials that are researching stem cell therapies. There are a few strategies that can go along way, however. Working with patient advocacy groups, for instance, lends credence to clinical trials, and can often help match trials with patients who are well suited for the research goals. Including some version of the phrase “Ask your doctor to contact us” is another surefire way for sponsors and CROs to make their claim for legitimacy, as fraudulent trials will often want to avoid the added scrutiny. Further, digital patient outreach that highlights evidence-based results through informative blog posts and site copy can help establish that clinical trials are not making false claims. For instance, sponsors and CROs testing a new blood pressure medication should be sure to feature patients’ past successes with the treatment prominently on their website, as well as address common concerns patients may have about the drug. With these measures, reputable clinical trials can affirm their credibility as well as distinguish themselves from the experimental treatments that have taken advantage of patients in the past.
