By Anna Rose Welch, Chief Editor, Biosimilar Development
Last week in my blog about the wacky legends healthy clinical trial volunteers tell in the clinic, I was particularly struck by the risks patients were supposedly willing to take for a large stipend. The impact of payments in clinical trials has been a topic I’ve noticed circulating through the industry over the past few weeks — especially in the case of H.I.V. trials.
There have been a few recent studies that questioned whether paying participants to take their meds and interact more regularly with doctors would lead to better treatment adherence, improve health, and slow the spread of H.I.V. infections. (In the U.S., for instance, only one quarter of the 1.1 million affected by H.I.V. regularly take the necessary treatments to keep from spreading the infection.)
Last month, The New York Times profiled a study carried out by the HIV Prevention Trials Network (HPTN) in the Bronx, NY, and Washington D.C. The HPTN 065 study set out to determine whether paying patients $280 a year to take their H.I.V meds, $25 to take H.I.V tests, and an additional $100 to attain results/a follow-up consultation would help improve treatment adherence and curb the spread of infection. Ultimately, the effort failed, despite the fact the trial shelled out an impressive $2.8 million in financial incentives to 9,000 patients. Clinics offering financial incentives only saw a 5 percent improvement in performance compared to the clinics that did not offer participants incentives.
Researchers did acknowledge that this approach could work in smaller clinics enrolling poorly performing patients; in fact, these particular sites saw a 13 percent improvement in performance. However, according to The NY Times, mathematical modeling suggests it would cost upwards of $5,000 a year per person to reduce the number of H.I.V. infections and cut the $230,000 to $338,000 costs associated with treating them.
Despite the importance of treatment adherence in a clinical trial, I can only imagine paying $5,000 per patient to ensure they take their meds is much too extravagant a fee for sponsors to handle, especially in the face of growing drug development costs. Not to mention, research published several years ago in the journal Social Science and Medicine revealed that patients perceive higher-paying trials as riskier, which might not necessarily help a trial’s/medication’s image.
While incentivizing treatment adherence wasn’t as successful as researchers hoped in the U.S., Mitchell Warren, executive director of AVAC told The NY Times that the amount the HPTN 065 study paid out to participants could be more alluring to participants in poorer nations — and in turn, encourage better treatment behavior.
However, some other research I came across in early February, seems to suggest the opposite. The $94 million NIH-sponsored VOICE trial (Vaginal and Oral Interventions to Control the Epidemic) enrolled over 5,000 women from Zimbabwe, South Africa, and Uganda. They weren’t making $280, per se — they were paid $10 to $15 dollars for each visit depending on the country. Regardless of the incentive, which was relatively lucrative for some more than others, a surprising number of the women gave away or disposed of their H.I.V. pills or vaginal gels. (After writing last week’s blog, I wasn’t surprised to learn some of the young participants did so out of fear after hearing some troubling rumors. My favorite was that their blood samples were being sold or used for Satanism.)
According to another New York Times article, this particular study has led some to question the ethics of paying patients for their time. Surveys showed women — especially poorer women in the high-risk group — were more likely to enroll in the trials because they wanted access to free tests and contraceptives, not just the stipend. However, some researchers were left wondering whether the stipends were more of a draw for the surprising 70 percent of women who participated but avoided taking treatments.
The Journal of Clinical Investigation (JCI) published an article focused on the common ethical concerns surrounding the practice of paying clinical research participants, such as that money can blind patients to risks, coerce patients into participation, or encourage them to lie in order to ensure participation to get the money (among many others). These concerns have been in place for quite some time, and the practice of paying research participants is not a novel concept. (In fact, it’s been around since the 1820s, Christine Grady wrote in her JCI article.)
While I doubt the practice of paying participants for certain clinical trials will ever be done away with, these two studies illuminate some of the tensions that continue to exist when payments are integrated into the trials. In the case of the African trial in particular, one expert from Fordham argued that we should not be blaming the payments for the faults of the trial’s research methods or patient consultation. Fordham’s Dr. Celia B. Fisher does bring up a good point in her statement, saying that communication about a patient’s hopes and fears in regard to the trial is a key step to ensuring a productive trial.
Based on the blog I wrote last week, and the fact that strange myths also made an appearance (and played a negative role) in this trial suggests to me that Fisher’s point about communication is a good one. There are valid concerns about the effect of payments on a trial. However, when it comes down to it, maybe focusing on the money is really just serving as a distraction from other key problems with trial protocol.