{"id":69952,"date":"2022-06-14T22:03:00","date_gmt":"2022-06-14T22:03:00","guid":{"rendered":"https:\/\/www.imperialcrs.com\/blog\/?p=69952"},"modified":"2023-12-06T09:27:13","modified_gmt":"2023-12-06T09:27:13","slug":"study-placebo-use-issues-and-answers","status":"publish","type":"post","link":"https:\/\/www.imperialcrs.com\/blog\/patient-recruitment-and-retention\/study-placebo-use-issues-and-answers\/","title":{"rendered":"Trial Challenges: Overcoming Objections to Study Placebo Use"},"content":{"rendered":"

I was asked to give my perspective on placebo-controlled trials. Using a study placebo presents challenges in recruitment and retention, especially because participants tend to hope that joining a study will lead to a positive treatment response.<\/p>\n

As I have mentioned in quite a few of my blog posts, I am a cancer patient. So my thoughts, like my experiences, come from that perspective and admittedly with my own biases. To expand the experience base for this post, I also spoke with additional participants from oncology trials.<\/p>\n

The placebo is ubiquitous. Placebos have been used for hundreds of years and were first demonstrated back in 1799. There are currently 30,297 placebo-controlled trials listed on clinicaltrials.gov<\/a>, of which 5,467 studies are not yet recruiting or actively recruiting.<\/p>\n

Study placebos are useful in determining efficacy. They enable a direct comparison between the current standard of care or no action and the introduction of a new drug.<\/p>\n

Study drug or study placebo? Participants want to know.\u00a0<\/strong><\/h2>\n

In placebo-controlled trials, every participant will devote a lot of thought to whether they are getting the active study drug or a placebo. It\u2019s human nature. We watch for symptoms, desperately hoping that symptoms mean a durable response.<\/p>\n

No one knows for sure until unblinding. Although clearly many patients I spoke to, most definitely believed they knew whether they were in the placebo arm or the treatment arm. When patients believe they are getting the placebo, they will often wish to opt-out of the trial.<\/p>\n

Leaving the study early<\/strong><\/h2>\n

\"A<\/p>\n

I recently interviewed clinical trial participants for an industry conference presentation<\/a>.<\/p>\n

Many notable comments stuck out, including this one: Michele decided to leave her Chicago-based oncology study, in part because she suspected she was in the placebo group. \u201cI\u2019d never had any side effects the entire time I did it, and so I really think I was getting the placebo the whole time,\u201d she told me.<\/p>\n

She wanted to be on active treatment, and she found another study.<\/p>\n

Some participants will even investigate. One woman I know spoke with other participants of the same study online and in the hospital waiting area. She found several were experiencing specific side effects. Since she had none of those side effects, she concluded she was receiving the placebo. Eventually, she requested to be unblinded. The request was refused, and she left the study.<\/p>\n

I\u2019ve heard these same scenarios on dozens of occasions, and it\u2019s easy to say these participants should never have left. However, these defections are perfectly understandable since they were oncology patients hoping to receive the study treatment.<\/p>\n

Equally understandable were the hospital\u2019s and the sponsor\u2019s reactions. They were very unhappy with the participants. They impacted the study data.<\/p>\n

Communication is paramount<\/strong><\/h2>\n

In so many areas of life, there is a benefit when we communicate. There are ways we can promote inclusion and involvement:<\/p>\n