1.) Preapproval Opportunities
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/CRO%2FSponsor+Articles/Preapproval-Opportunities/ArticleStandard/Article/detail/522052?contextCategoryId=44942&searchString=patient%20organizations/
2.) Mission Possible: Rebranding Clinical Research
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=416537&sk=&date=&pageID=3&searchString=patient%20organizations/3.) Recruitment Strategies: A European Perspective
http://appliedclinicaltrialsonline.findpharma.com/appliedclinicaltrials/article/articleDetail.jsp?id=306615&sk=&date=&%0A%09%09%09&pageID=4&searchString=patient%20organizations/
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The essential role that patient organizations can play in the research process, particularly in clinical trials, is often
overlooked. The last four decades show not only a steady growth of the number of patient organizations but also an increasing
interest in the research process and drug development.
Nowadays, patient organizations can offer traditional, scientific research additional knowledge. Knowledge that is derived
from the practices and experiences from the patient organizations.
The combination of traditional, scientific knowledge (evidence based) with the practice based-knowledge from patient organizations
creates an added value. This added value can play an important role in the development of clinical trials.
Several examples of this added value will be mentioned in this article. Furthermore, the article explores the differences
between patients, consumers, and clinical trial participants.
Unique roles
There is a large difference between consumers as incidental users of health care and patients who are more or less constant
users of health care services. The citizens of our society in their role of consumers are mostly interested in minimizing
their health care insurance costs. These same citizens in their role as patient are more interested in questions such as where
do I find the best doctor? The best hospital? And the best treatment or medication for my disease?
As a consequence, patient groups stand more alongside the research community, acting as a critical friend and as part of the
process to find solutions for unmet medical needs. On the contrary, consumer organizations take a more confrontational stance,
stressing the risks, dangers, and problems of medical research.
The difference between consumers and patients is also relevant when answering the question: Who is the trial participant?
The trial participant can be a healthy volunteer who is getting paid for their cooperation. The trial participant can also
be a consumer, who all of a sudden gets ill and at the time of the diagnosis will be asked to participate in a trial with
relatively little background knowledge. And in regard to providing informed consent, has had little or no time to think about
the decision. The trial participant can also be a patient, partially organized in a patient group or aware that there is a
patient group and has some background knowledge of the condition and respective treatment options.
Trial participants are seldom organized, nor have contacts with patient or consumer groups. Trial participants are represented
in research ethics committees (EC) by laypersons, and these laypersons also have almost no contacts with trial participants
and patient or consumer groups.
For most clinical research organizations, investigators, and pharma companies, it's not easy to contact potential trial participants
if they're not organized in patient groups.
