Educating Patients on Clinical Trials
There is a growing concern about lack of patients for participation in clinical trials – trials needed to fuel evidence-based research so scientific based recommendations regarding health care trends can be made. For example, according to the Coalition of Cancer Cooperative Groups, only 3% of U.S. adults with cancer participate in clinical trials, a number too small to determine the effectiveness of a treatment, drug or supplement. Nearly 200,000 newly diagnosed patients may be eligible to take part in cancer trials, but only about 50,000 do so according to the Coalition of Cancer group.
What prohibits the participation? According to researchers, it is fear. But studies show otherwise – they show it is ignorance of the option of a clinical trial. According to one study, 85% of cancer patients were either unaware or unsure at their time of diagnosis that participation was an option. So, various outreach organizations are out to educate the public on why clinical trials are necessary and how to find out if one if right for the patient. Among other outreach efforts, the Center for Information and study on Clinical Research Participations is trying to raise awareness of the benefits of clinical trials. They offer information to patients and try to help match a trial to the patient. Other resources include the free web tool EmergingMed.com (http://www.emergingmed.com/) – unlike other free tools like ClinicalTrials.gov, EmergingMed actually compares patients’ short personal profiles to the enrollment criteria for thousands of trials in minutes.
Some of the questions trial participants should ask are the following:
• How do the risks, side effects and benefits compare with my current treatment?
• Who pays for the experimental treatment?
• How will patients be informed about new risks identified during the trial?
• Will results of the trial be provided to me?
Clinical Trials are methods of gathering data to determine the best treatments available and risks associated with the treatments. Educating the public about the need for these studies is one step towards achieving the necessary gathering of information for evidence-based practice.
About the Author
Kathy Shattler received her Master of Science degree from Michigan State University in E. Lansing Michigan in Human Nutrition. Her twenty-two years of practice includes holding positions as a Lecturer, Chief Clinical Dietitian and Program Manager. Kathy is the Founder of Nutri-Care Consulting and is currently the Nutrition Director of www.CEU4U.COM, an online continuing education management company for Registered Dietitians and Dietetic Technicians.
Dan responds:
Posted: June 18th, 2008 at 10:04 pm →
Published on www.brainblogger.com
The Human Injury of Lost Objectivity
If I were to rate the corruptive tactics performed by big pharmaceutical companies, the intentional strategy of implementing fabricated and unreliable results of clinical trials performed by others, yet sponsored by a pharmaceutical company, would be at the top of the list. By this atrophy of the scientific method absent of authenticity, harm and damage is possibly done to the health of the public. Most would agree that the science of research should be sound and sterile that is completely free of interference. However, it appears, money and increased profits can be a catalyst for reckless disregard for human health that is largely unregulated.
Decades ago, clinical trials were conducted at academic settings that focused on the acquisition of knowledge and the completely objective discoveries of meds. Then, in 1980, the Bayh-Dole Act was created, which allowed for such places to profit off of their discoveries that were performed for pharmaceutical companies in the past. This resulted in the creation of for-profit research trial sites, called Contract Research Organizations that are often composed of community patient care clinics. Because of this structure, investigators of these trials are likely void of necessary research experience or quality regarding their research purpose and ability to ensure its sterility. These quite numerous CROS are for- profit, with some CROs making billions of dollars a year.
The trials conducted at such places are sponsored by pharmaceutical companies that control and manipulate all aspects of the trial being conducted involving their med being studied in the trial. Etiology for their deception regarding this manipulation is because the pharmaceutical company that sponsors such a trial is basically creating a marketing tool for the studied drug of thiers. This coercion is done by various methods of deception in subtle and tacit methods. As a result, research in this manner ensures favorable results of the sponsor’s medication. Their activities are again believed to be absent of true or applied regulation, and therefore have the autonomy to create whatever they want to benefit what may be a collusive relationship between the site and the sponsor.
Further disturbing is that once the creation of the trials is completed, the research paper is often composed with specific directions by the sponsor to writers known as ghostwriters. These people are not identified and acknowledged by the sponsor, and may not be trained in clinical research overall, as they are simply freelance writers, as one does not need research training or certification in order to perform this function. Rarely do trial ghostwriters question their instructions about their assignment, which is clearly deceptive and undocumented by the sponsor. Also, these hired mystery writers are known to make about 100 grand a year. This activity removes accountability and authenticity of the possibly fabricated clinical trial even further. The corruptive act is finally completed by the sponsor hiring an author to have their name be placed on the trial, while this hired author likely had absolutely no involvement with the trial, or even reviewing the trial is not asked by the hired author.
To have the trial published, the sponsor has been known to pay a journal, and the sponsor bribes the journal in a few ways, such as the sponsor purchasing from a selected journal thousands of reprints of their study from the journal, for example. Again, how often this process is performed is unknown, yet frequent enough to create hundreds of such false writers mentioned earlier and progressively growing research sites to receive the support the pharmaceutical industry. So benefits of meds studied in such a malicious way potentially can harm patients and their treatment options along with clear safety risks. The purchased reprints bought by the sponsor of the study are distributed to the sponsor’s sales force to share the content with prescribers, with the sales force completely unaware about this manipulation. As a bonus, the sponsor may pay this journal to advertise their products to be placed in this journal as well.
Such misconduct discussed so far impedes research and the scientific method with frightening ethical and harmful concerns.. If so, our health care treatment options with meds are now undetermined in large part due to such corruptive situations, as well as the absence of objectivity that has been intentionally eliminated with trials produced in this way. Trust in the scientific method in this type of activity illustrated in this article is absent.
More now than ever, meds are removed from the market are given black box warnings. Now I understand why this may be occurring.
Transparency and disclosure needs to happen with the pharmaceutical industry for reasons such as this as well as many others, in order to correct what we have historically relied upon for conclusive proof, which is the scientific method. More importantly, research should not be conducted in a way that the sponsor can interfere in such ways described in this article, which would require independent clinical trial sites with no involvement with the drug maker. And clearly, regulation has to be enforced not selectively, but in a complete fashion regarding such matters. Public awareness would be a catalyst for this to occur, after initially experiencing a state of total disbelief that such operations actually are conducted by such people, of course. We can no longer be dependent on others for our optimal health. Knowledge is power, and is also possibly a lifesaver.
“Ethics and Science need to shake hands.” ……. Richard Cabot
Dan Abshear
Author’s note: What has been written was based upon information and belief.