October 2nd, 2019 FDA Advises Limiting Placebos in Cancer Clinical Trials In an official guidance released in August, the FDA recommended avoiding the use of placebos in clinical trials for life-threatening diseases. Placebos are an important part of clinical research, but in some trials – such as those involving life-threatening diseases – they may create a disadvantage for patients. An official guidance released by the Food and Drug Administration (FDA) last month recommends that cancer trials in particular should limit their use of placebos. While steering clear of placebos has been common practice in cancer studies for many years, the FDA guidance establishes a clear standard for patient-centric trial design. The FDA encourages sponsors and CROs to use placebos only in certain situations, such as when no proven intervention exists or when patients receive a placebo in addition to an established treatment. Trials that are designed in this way can meet the needs of both researchers and participants. The Role of Placebos in Clinical Trials “Placebos are often used in clinical trials. However, patients fighting life-threatening diseases, like certain cancers, shouldn’t be given a placebo when there is a known effective therapy,” said Acting FDA Commissioner Ned Sharpless in a recent Tweet. In addition to limiting the use of placebos, the FDA’s guidance outlines important steps sponsors and CROs can take when executing a placebo-controlled study. For instance, it’s essential to establish a scientific or methodological reason for using a placebo, especially when an effective treatment is already available. In the case of disease progression or an adverse event, unblinding clinical trial patients and investigators is generally preferable. However, if sponsors and CROs intend to maintain patient-level blinding, the FDA guidance suggests that this should be made clear in informed consent documents. Further, trial protocols should include a detailed plan for blinding and unblinding participants. By following these recommendations, sponsors and CROs can ensure they are meeting the highest ethical standards and providing the best quality of care to trial participants. Additionally, transparency about the use of placebos – or lack thereof – can help clinical trials build credibility and trust with patients. Addressing Placebos in Digital Marketing Studies have shown that the possibility of receiving a placebo can discourage potential patients from joining clinical trials. In a survey of users in the PatientsLikeMe network, 23 percent of patients reported that the chance of getting a placebo was a barrier to clinical trial participation. Many patients also overestimate the use of placebos in clinical trials, believing that their likelihood of receiving a “sugar pill” is high. As more clinical trials start to forgo the use of placebos, it will be important to proactively address patients’ fears. By engaging in strategic digital marketing efforts including SEO, pay-per-click (PPC) advertising, and social media, sponsors and CROs can spread accurate, reassuring information about clinical trials. PPC in particular enables sponsors and CROs to utilize keywords like “placebos in lymphoma trials” or “cancer trials with no placebo” to target patients based on their search intent. Search ads based on these keywords direct users to clinical trial sites, where, if applicable, the copy can reassure patients that they won’t receive a placebo, or that they may be given one only in addition to a proven treatment. Landing pages with headers like “Breast Cancer Clinical Trial: All Patients Receive Treatment” are also a clear and simple way to address patients’ concerns. Ultimately, sponsors and CROs who oversee research that does not involve the use of placebos – or that only uses placebos in a limited capacity – should make these benefits clear to patients through the use of robust digital marketing campaigns. In more cases than not, this will make patients feel more confident about enrolling in studies that will give them access to cutting-edge treatment.
In an official guidance released in August, the FDA recommended avoiding the use of placebos in clinical trials for life-threatening diseases. Placebos are an important part of clinical research, but in some trials – such as those involving life-threatening diseases – they may create a disadvantage for patients. An official guidance released by the Food and Drug Administration (FDA) last month recommends that cancer trials in particular should limit their use of placebos. While steering clear of placebos has been common practice in cancer studies for many years, the FDA guidance establishes a clear standard for patient-centric trial design. The FDA encourages sponsors and CROs to use placebos only in certain situations, such as when no proven intervention exists or when patients receive a placebo in addition to an established treatment. Trials that are designed in this way can meet the needs of both researchers and participants. The Role of Placebos in Clinical Trials “Placebos are often used in clinical trials. However, patients fighting life-threatening diseases, like certain cancers, shouldn’t be given a placebo when there is a known effective therapy,” said Acting FDA Commissioner Ned Sharpless in a recent Tweet. In addition to limiting the use of placebos, the FDA’s guidance outlines important steps sponsors and CROs can take when executing a placebo-controlled study. For instance, it’s essential to establish a scientific or methodological reason for using a placebo, especially when an effective treatment is already available. In the case of disease progression or an adverse event, unblinding clinical trial patients and investigators is generally preferable. However, if sponsors and CROs intend to maintain patient-level blinding, the FDA guidance suggests that this should be made clear in informed consent documents. Further, trial protocols should include a detailed plan for blinding and unblinding participants. By following these recommendations, sponsors and CROs can ensure they are meeting the highest ethical standards and providing the best quality of care to trial participants. Additionally, transparency about the use of placebos – or lack thereof – can help clinical trials build credibility and trust with patients. Addressing Placebos in Digital Marketing Studies have shown that the possibility of receiving a placebo can discourage potential patients from joining clinical trials. In a survey of users in the PatientsLikeMe network, 23 percent of patients reported that the chance of getting a placebo was a barrier to clinical trial participation. Many patients also overestimate the use of placebos in clinical trials, believing that their likelihood of receiving a “sugar pill” is high. As more clinical trials start to forgo the use of placebos, it will be important to proactively address patients’ fears. By engaging in strategic digital marketing efforts including SEO, pay-per-click (PPC) advertising, and social media, sponsors and CROs can spread accurate, reassuring information about clinical trials. PPC in particular enables sponsors and CROs to utilize keywords like “placebos in lymphoma trials” or “cancer trials with no placebo” to target patients based on their search intent. Search ads based on these keywords direct users to clinical trial sites, where, if applicable, the copy can reassure patients that they won’t receive a placebo, or that they may be given one only in addition to a proven treatment. Landing pages with headers like “Breast Cancer Clinical Trial: All Patients Receive Treatment” are also a clear and simple way to address patients’ concerns. Ultimately, sponsors and CROs who oversee research that does not involve the use of placebos – or that only uses placebos in a limited capacity – should make these benefits clear to patients through the use of robust digital marketing campaigns. In more cases than not, this will make patients feel more confident about enrolling in studies that will give them access to cutting-edge treatment.
