June 3, 2019

Clinical Trials

Are they worth the risk?

Peter N. Landless & Zeno L. Charles-Marcel

Q:Even though my husband and I have followed a healthy vegetarian lifestyle for more than 25 years, my husband was recently diagnosed with a difficult-to-treat cancer. How could this happen? Our oncologist has offered to enroll my husband, free of cost, in a “clinical trial” using a drug regimen that is potentially much more effective than the current standard treatment. The standard treatment includes an expensive medication that our insurance does not cover. Who wants to be involved in a trial? How dangerous is being in a trial? Aren’t “clinical trials” just experiments using people as “guinea pigs”? How can we be sure he is getting the new medication and not just a worthless sugar pill? We want to do the best for my husband. We’re scared.*

A:With all the advancement in cancer treatments, cancer is still a scary diagnosis. Most adults in the United States know—or know of—at least one cancer survivor; many people today have been considered cured! Your situation is serious but not hopeless.

A clinical trial is a research study in which human subjects are prospectively assigned some specific treatment to evaluate its effects on health outcomes. The patient is not on trial; the new treatment is. It is how we get to know how effective and safe (or not) treatments used on lab animals are for humans.

The feasibility and safety of human research are assessed by a mandatory review by a group that includes “regular,” or nonmedical, people who authorize or prohibit the study. Treatments now considered “standard” had to pass through this process with other volunteers. As with any treatment, even with lifestyle interventions, you should be provided (or seek out yourself) enough understandable information about it and reasonable alternatives to determine the potential benefits weighed against the potential risks and cost.

Because participants are randomly assigned, no one knows who will receive the “new” medication or the placebo; but everyone will receive at least the current standard. Your participation is voluntary and revocable at any time in the process. Call for prayer from your local church elders; involve your husband’s personal physician and longtime friends; prayerfully, carefully decide.

Healthful living reduces our risk of many diseases and can even reverse some diseases already established, but elimination of all diseases is not assured. Because our world is marred by sin, there is and will be sickness, suffering, and death. Yet this situation will not last forever, and we do not have to go it alone. Support from believing family, friends, and cancer survivors; being active in “doing the best you can under present circumstances”; and being especially close to God to find meaning even in hardship—all these bolster hope, the confident expectation of what God has promised: “Let not your heart be troubled” (John 14:1).

Plans are in place for the everlasting, permanent solution to cancer and all disease, even death. We join you in prayer. Hope’s strength is God’s faithfulness.

* This query and answer are phrased to protect the questioner’s identity while providing good information about clinical trials.

Peter N. Landless, a board-certified nuclear cardiologist, is director of Adventist Health Ministries of the General Conference. Zeno L. Charles-Marcel, a board-certified internist, is an associate director of Adventist Health Ministries at the General Conference.