Clinical Drug Trials and Risks
We at therubins would like to thank
Laurie Cooper, Librarian, Reference Daily for the
following recommendation to be added to this site: - http://www.healthopedia.com/drugs/
(9/19/16)- The Department of \Health and Human Services (HHS) and the National Institute of Health (NIH) have promulgated the final rule on www.nih.gov for clinical trial registration and follow-up on www.clinicaltrials.gov . The NIH site contains the press release dated September 16, 2016.that links into the new rule. There are now over 230,000 clinical trials listed on that site. .
The clinical trials listed on the site contain data on drugs, biologics and medical devices being tested. Negative results as well ae positive results will have to be included, subject to loss of funding from the agencies.
(2/13/14)- The National Institutes of Health, 10 large drug companies and seven nonprofit organizations announced a 5-year partnership to attempt to speed up the development of drugs to treat Alzheimer’s disease, Type 2 diabetes, rheumatoid arthritis and lupus.
The initial price tag is $230 million, and by pooling their research resources and sharing them with the public, the project called the Accelerating Medicines Partnership hopes to gain a better understanding of how each of the four diseases works, and then use that knowledge to find molecules that play an important role in the course that each of the diseases can take.
The new agreement bars participants from using any discovery for their own drug research until the project makes data public on that discovery. The consortium will share all findings with the public, for anyone to use freely to conduct their own research.
(4/8/13)- According to the U.S. National Institutes of Health's ClinicalTrials.gov website, there are currently 139,372 clinical studies being conducted throughout 182 countries as of Jan. 28, 2013. The number of registered clinical studies has increased by an average of 28% annually since the year 2000. According to PhRMA, $49 billion was spent last year on researching more than 2,900 compounds
(4/4/09)- Pharmaceutical companies are now going outside this country to a much greater extent then ever before to conduct clinical trials of their drugs, since it is much less expensive for them to do this in foreign countries than it is in the U.S.
Some 700 clinical trials were being conducted in India, China and Russia last year, up from fewer than a total of 50 in those three countries in 2003, according to the U.S. National Institutes of Health figures.
Many medical professionals are questioning the safety of these trials since many of the people conducting these trials do not have the qualifications that are required of medical personnel in this country.
(6/5/05)- The June 2005 edition of the New England Journal of Medicine published the results of the trial of the shingles vaccine from Merck that we discussed in our item on 3/14/05. I was a participant in the trial for a little over 4 years, and after the trial was over I was informed that I had received a placebo, not the vaccine.
The study was done under the leadership of Dr. Michael N. Oxman a staff physician in infectious disease at the VA San Diego Healthcare System. It was determined that the vaccine reduced both the incidence and severity of shingles by more than half. Merck, the developer of the vaccine, has applied to the FDA to receive approval, which it hopes to receive by February 2006.
The same virus that causes chicken pox causes shingles. The virus (varicells-zoster) remains dormant so that people who have had chicken pox are more susceptible to getting shingles. Shingles affects anywhere from 300,000 to 900,000 people a year in this country, according to the CDC. The condition need not be reported to the CDC so that is why there is not a more exact figure on the number of people who do get the disease.
Of the 19,254 people in the vaccinated group (Zostavax), 315 got shingles and 27 of them continued to suffer from the rash more than 3months later. Of the 19,247 in the placebo group (my group), 642 got shingles and 80 still had the rash 3 months later. A spokesman for Merck said that the company had not determined the price that it would charge for the vaccine once it had gained approval to sell it from the FDA.
(3/14/05)-One of the co-editors of this site was a voluntary participant in a recently completed 4-year Shingles Prevention Study that investigated the effectiveness of a varicella-zoster vaccine for the illness. According to Dr. Michael N. Oxman, the National Study Chairman, the "vaccine reduced the frequency and severity of Shingles and Postherpetic Neuralgia (long lasting pain after the rash disappears) for many subjects." We discussed this study on 6/25/04.
Dr. Oxman's letter to the participants in the study went on to state that, "Based on these results, we understand that Merck intends to pursue approval of the investigational varicella-zoster vaccine from the Food and Drug Administration (FDA)." The letter goes on to state that the FDA approval process is going to take at least a year or more.
(6/25/04)- My brother is also involved in a drug trial, which is his case involves a study being conducted at the Veterans Administration in New York in connection with a potential vaccine for shingles. In order to qualify for this study the subjects had to have had chicken pox, be over the age of 50 and never have had shingles. He had read about the search for subjects in an article that he read in the New York Times on shingles. The study has been concluded and the results should be announced shortly.
Before being allowed to enroll in the study he was interviewed and examined by the study team at the VA Hospital in Manhattan. He was shown a movie about shingles and also given written material to read about the topic. A nurse thoroughly explained the risks associated with being involved as a subject in the test. He was also told that he would not know whether or not he would be receiving a placebo or the vaccine involved in the study. He was than given some time to think it over before deciding whether or not he would want to be a subject in the test. After deciding that he wanted to be involved in the test he was given an injection with either a placebo or the potential vaccine for shingles.
The study lasted for a four-year period of time. He must call in once a month to answer some questions, which would indicate whether or not he has come down with shingles. The telephone interview lasts for about 30 seconds.
Thinking of taking part in a drug research study? Well, the chances of finding a study to fit the particular disorder are excellent. Consider these facts: "more than 80% of clinical research trials are being delayed because there are not enough volunteers" (Wall Street Journal article, April 11, 2002); "6000 new drugs, procedures and treatments are being tested in 80,000 different locations around this country" (Ibid.). The big question is how to find the study that meets your needs. Presently, there is a governmental site, www.ClinicalTrials.gov, with listing of government-funded trials. Now federal rules have expanded the role of this site to include industry-sponsored trials.
There are also nonprofit sites that are geared to specific diseases where you can find references to particular studies. All that needs to be done is use your keyword box on your browser and put in key words such as "clinical trials" or related words to the disease you are interested in determining if there are any ongoing clinical trials.
It has been noted that there are some commercial sites that are paid to solicit individuals to enter drug trials and that some have financial conflicts, especially when these services work on the bounty method, getting up to $1000 per individual they enter into a study.
Finding the research study trial is probably the easy step. Determining the risks of entering the trial is more challenging. Where serious illness is concerned, individuals tend to take risks based on the faint hope that the trial may prove beneficial to their health. At the same time, apprehension exists because of some well-publicized negative research including deaths. While deaths do occur, the data indicates that one out 10,000 die of the effects of medication in research studies and that one in 30 study subjects will have a serious adverse event. So while there is hope in clinical trials, keep in mind that these are trials, not guaranteed methods of a better outcome. If the latter were true, the drug would be available to all that need it.
Individuals are strongly urged to check with their treating physician about any questions involved in entering a study. Questions could include the following: Is there a treatment that has been approved by the FDA that is more hopeful than the treatment in the study? What are the risks of entering a study as opposed to the benefits?
Most drug studies involve a placebo-control group, with investigators blind to what group a research patient is in. There is no guarantee that you will be getting the research drug. Figures indicate that 2.3 million people completed clinical drug trails in 2001. Probably about one-half did not get the experimental drug, getting a placebo (dummy pill). The exception to this type of protocol involves studies with terminally ill patients (those for whom no further treatment is available), who will not be given a placebo. These studies represent experiments on human subjects.
In a 1999/2000 Centerwatch (www.centerwatch.com) survey of 1050 volunteers, 49% of patients’ biggest worry at the start of a clinical trial was getting a placebo; 35% worried about side effects and potential risk; and 29% worried about access to the drug after the trail. This site lists over 41,000 active industry and government-sponsored clinical trials. It is sponsored by the companies that are seeking participants in their drug trials.
Before starting in a clinical drug trail, an individual will have to sign an informed consent document. This document should explain how long the study is going to take, what risks and discomforts there might be and how patients will be compensated for expenses. Remember Medicare will extend coverage to the costs of routine care, including lab and radiology services, provided with qualifying clinical trails. There is a pamphlet available through the American Association of Health Plans called "Should I Enter a Clinical Trial" at www.aahp.org that may be helpful to some.
Note: According to the Wall Street Journal article cited above: "Though CenterWatch gets a fee from industry trials it lists, it doesn’t recruit patients or sell patient information. It lets consumers sign up for a free, confidential e-mail message whenever a clinical trial for a particular condition is listed on the site. It also offers to notify users about newly approved drugs for specific medical conditions."
What is it like to be in a study? The wife of this writer is presently in a study evaluating a medication for osteoporosis, a potentially disabling but non-pathological disorder. A thorough physical examination was used to determine the rather narrow criteria of entry into the study (something like one in fifty got accepted into the study). Acceptance was based on three independent evaluations of her test results at different sites throughout the world.
Still unaware of whether she is taking the drug or placebo, the study, lasting two years, calls for visits every three months to the drug investigators to check pill intake and get a medical inventory to monitor progress. The study will end in June of this year. She has already been asked to enter another study when this drug trial is over.
There is no guarantee that she will get the drug being used when the present trial is over. Her initial physical was more extensive than those she gets in her yearly check-up. There has been someone on call to assist her if she experiences any adverse effects during the trials. Being in this study did not mean giving up visits to her primary care physician. The medication she receives is free. She hopes that something will come out of this study that could be helpful to her fellow human beings.
Another good site to go to that lists some of the drug trials is www.trialscentral.org which is the Web site of the Center for Clinical Trials and Evidence Based Healthcare at Brown University. The National Library of Medicine has a consumer site with a link to PubMed at www.medlineplus.gov which contains a database with citations and abstracts from nearly 4,500 journals world-wide.
Please also see our article on this topic:
Disclosure of New Clinical Drug Trials to the Community
Alzheimer's Disease-Clinical Trials-Part XX
FOR AN INFORMATIVE AND PERSONAL ARTICLE ON PRACTICAL SUGGESTIONS WHEN SELECTING A NURSING HOME SEE OUR ARTICLE "How to Select a Nursing Home"
Harold Rubin, MS, ABD, CRC, Guest Lecturer
updated September 19, 2016