When Tina Banwart agreed to write a guest blog, I was ecstatic. Tina writes an amazing hepatitis C blog, HCV New Drug Research. What she provides to the hepatitis C community is so good that I thank my lucky stars that we have her. The piece that follows is a consumer advocacy piece alerting those considering clinical trials, but it could be applied to the entire healthcare industry.
Blue skies and a big old smiley sun greeted me as I awoke to the aroma of freshly brewed java. “What a glorious day!” I thought to myself as I tinkered with my coffee. Once my cup of joe was complete I sat down at my computer to begin my daily search for a few noteworthy updates on hepatitis C.
What began as a lovely morning abruptly ended with a confusing press release describing a new clinical trial for hepatitis C. It seemed less like a notification of a new drug trial and more like an instrument of marketing. Frankly, this was an advertisement with a disturbing title; New Phase 2 Paid Hepatitis C Clinical Trial Now Enrolling at Avail Clinical Research in Central Florida; Accepting Male& Female Participants Age 18-70.
Obviously, the word “Paid” in the heading was the first red flag; other red flags presented themselves throughout the press release.
What ensued was a week long obsession over the clinical trial, including many hours of research and a few phone calls to investigate the validity of the study.
I began by contacting the company named in the study headline, which only added to my bewilderment. With my curiosity peaked, I had a few questions: who is the pharmaceutical company, what drug was being tested, and why weren’t these important facts included in the description of the trial? Oddly enough, an arm with telaprevir was mentioned in the trial description, which I’ve provided below.
The new Hep C drug is a novel hepatitis C virus (HCV) NS5A inhibitor being developed for the treatment of chronic HCV infection. This Phase II, multicenter, parallel-group, randomized, dose-ranging study will assess the safety and tolerability, antiviral activity, and pharmacokinetics of the new drug at 2 dose levels (40 and 60 mg) in combination with pegylated interferon alfa-2a (PEG) and ribavirin (RIBA) in approximately 100 treatment-naïve subjects with chronic genotype 1 HCV infection.
Subjects will be randomly allocated on a 2:2:1 basis to 2 dose levels of the new drug or telaprevir and will be stratified by interleukin 28B (IL28B) rs12979860 status, HCV viral genotype (i.e., 1a vs 1b), and baseline HCV viral load. Telaprevir, PEG, and RIBA will be administered in an open-label manner while the 2 dose levels of this new Hep C drug will be administered in a double-blind manner.
In a separate nonrandomized single-arm cohort, up to 15 treatment-naïve subjects with genotype 4 chronic HCV infection will be enrolled in parallel at the dose level of 60 mg of the new Hep C treatment. After completion of 12 weeks of the new drug along with PEG and RIBA, subjects will continue with 12 or 36 additional weeks of PEG and RIBA treatment depending on virological status.
Subjects randomly assigned to the telaprevir arm will receive therapy with PEG, RIBA, and telaprevir according to the telaprevir label. The primary objective of the study is to evaluate the safety and antiviral activity of the new drug when given in combination with PEG and RIBA.
Full press release..
When I asked the clinical advisor to name the pharmaceutical company and the drug being tested in the trial – I was told that information isn’t released until the individual qualifies for the study. This was confirmed by a second clinical advisor when I called the next day. However, because the trial description included a telaprevir arm, I inquired about that part of the study. The advisor had a hint of apprehension in his voice when he cautiously admitted the press release had been a mistake, apparently, that part of the study was on hold because of regulatory issues.
When information is withheld in either a press release or in this case by a trial advisor, it may be an indication that the trial is privately run and industry funded.
When an unsuspecting patient reads a press release about a new clinical trial the funding source of the trial may not seem significant. From the patient’s perspective a trial is a trial, a study is a study. However, if a physician was to read the same press release it would likely be filtered through a veil of skepticism. There are a number of factors that contribute the controversial nature of clinical trials funded by the pharmaceutical industry. In a general sense, to physicians, trials funded by the pharmaceutical industry are not inherently viewed as good or bad, but remain controversial for good reason.
Recently, Medpage Today reported that;
“Physicians tended to be skeptical of clinical trials funded by the pharmaceutical industry, even if they considered the study design to be methodologically rigorous, an analysis based on hypothetical studies found. Note, however, that physicians were half as willing to prescribe drugs studied in industry-funded trials as they were to prescribe drugs studied in NIH [The National Institutes of Health (NIH) is a part of the U.S. Department of Health and Human Services] -funded trials across all levels of methodologic rigor.”
The Medpage article summarizes a study published September 20, 2012 in The New England Journal of Medicine that included statistically significant findings that physicians are weary of the validity of these private sector trials. The data from these privately funded trials was not outright dismissed by the medical community taking part in the study, but clear distinctions were drawn by the physicians in regards to the funding source of the trials.
On September 19th, one day after my conversation with the clinical research company another press release for the study was issued, although this time the telaprevir arm of the study was omitted. In this new press release no mention of a change in the study was included. At the time this article was written the original September 17th press release and the altered September 19th press release remain simultaneously published online.
What Can We Learn From This Press Release?
Alert yourself to red flags, and proceed with caution when a study is advertised as a “Paid” clinical trial, especially if the press release reads more like an advertisement then a notice of a new study. A study description should include all relevant information upfront and if significant information is missing this may be a red flag. Find out who is conducting the trial, and the trial’s funding source.
The study cited in the Medpage article showed with statistical significance physicians agree that academically run trials are less about profit and more about scientific understanding. On average these academic institutions usually have more checks and balances in place that often allow for objective research.
Fortunately the federal government has strict guidelines and safeguards in place to protect study participants. A clinical trial must be approved and monitored by an Institutional Review Board (IRB).
The following information can be found at The National Cancer Institute Website:
Institutions have an Institutional Review Board (IRB) made up of medical specialists, nurses, social workers, medical ethicists, and patient advocates. The IRB reviews all clinical trial protocols and approves only those that address medically important questions in a scientifically and ethically responsible manner. It also reviews all informed consent documents to make sure that they provide clear and complete information for those who may wish to take part.
Lastly, you will be asked to sign an informed consent document before enrolling into the clinical trial – the document is explained in more detail below. Remember time is allowed for study participants to review the documents. You are under no obligation to sign the informed consent document at the time it is presented, instead take the consent form home for a few days to review with your family; write down any questions you may wish to discuss with your physician or research team.
The following information can be found at The the National Institutes of Health (NIH) Website:
Informed consent is the process of providing potential participants with the key facts about a clinical trial before they decide whether to participate. The process of informed consent (providing additional information) continues throughout the study. To help someone decide whether or not to participate, members of the research team explain the details of the study. Translation or interpretive assistance can be provided for participants with limited English proficiency. The research team provides an informed consent document that includes details about the study, such as its purpose, duration, required procedures, and who to contact for further information. The informed consent document also explains risks and potential benefits. The participant then decides whether to sign the document. Informed consent is not a contract. Volunteers are free to withdraw from the study completely or to refuse particular treatments or tests at any time. Sometimes, however, this will make them ineligible to continue the study.
Where Can I Get More Information About Clinical Trials?
Before entering into a clinical trial please take the time to read this comprehensive guide available at HCV Advocate: Guide to Understanding Clinical Trials and Medical Research in Hepatitis C.
National Institutes of Health: Learn About Clinical Studies
Where Is The Best Place To Search For A Clinical Trial?
CenterWatch Web site: www.centerwatch.com
National Institutes of Health (NIH) Clinical Trials Website: www.clinicaltrials.gov