The Challenge of Finding a Clinical Trial
In the words of Patty Delaney, a survivor of Hodgkin’s disease and a member of the U.S. Food and Drug Administration’s Cancer Liaison Program in the Office of Special Health Issues…
In the fall of 1997, the United States Congress did a remarkable thing for people diagnosed with life-threatening diseases. They passed a law that launched a public access database known as ClinicalTrials.gov. This law requires clinical trial sponsors to list their trials studying the effectiveness of drugs to treat people with serious diseases on ClinicalTrials.gov. This database now makes it possible for patients and their doctors faced with complicated treatment choices to locate clinical trials the person may be eligible to enter.
I know about facing complicated treatment choices because I had to make them. At the age of 43, I was diagnosed with stage IV Hodgkin’s disease – cancer of the lymphatic system. At the time of diagnosis, I had six tumors including liver involvement.
Overwhelmed, frightened, and confused, I sorted through a seemingly incomprehensible system and entered a clinical trial at the National Cancer Institute. Like many other people with cancer, I experienced first hand how difficult it is to learn about cancer clinical trials.
My passion for educating cancer survivors about clinical trials does not derive from the fact that I was a clinical trial participant, but from the fact that when I was diagnosed with cancer that had extensive tumor involvement, I was still told that I had a 70 percent chance at five-year, disease-free survival.
I wondered how could this be, when almost any other type of cancer diagnoses would certainly not be survivable with this much tumor involvement. Slowly, I came to understand the answer to my question.
The answer is that in the 1960s and 1970s, clinical trials were conducted that gradually, but progressively, resulted in effective combination chemotherapy to treat advanced Hodgkin’s disease.
When I began to investigate entering a clinical trial, my diagnosing physician was not at all supportive, which frightened me – an intransigent problem that persists today. A physician friend at the National Cancer Institute told me about the Hodgkin’s disease trials they were conducting. During my discussions with the NCI staff, I learned that much of the early breakthroughs in Hodgkin’s treatment were developed at the NCI and I was impressed.
I liked the idea of being followed by a team of oncologists with extensive background in the staging and treatment of Hodgkin’s disease, since it is a low-incidence cancer. I also learned that both arms of the trial were considered effective therapies. The NCI investigators were trying to determine whether the outcomes from using the standard therapy could be improved by adding four additional drugs. And so I made the decision to enter the NCI clinical trial in spite of the disapproving comments of my community oncologist.
It was only many years later that I realized how privileged I was to even find out about the existence of the clinical trial. A Harris Interactive survey of 6,000 cancer patients conducted in 2000 reported that 85 percent of the respondents “…were unaware that participating in a clinical trial was a treatment option.” The survey went on to report “…While primary care physicians and oncologists believe more cancer patients should enroll in clinical trials, these physicians do not uniformly encourage participation.”
Without a physician suggesting the clinical trial option, patients are left to their own ingenuity in pursuing clinical trial information – in other words, patients who have resources such as time, money to make phone calls, and the “insider” network that connects those who have access. It should therefore not be a surprise to learn that less than five percent of adult cancer patients participate in clinical trials.
Dr. Vincent DeVita, formerly the director of the National Cancer Institute, said that if we could get 10 percent of cancer patients to participate in clinical trials we would have the answers to questions about a therapy’s effectiveness in one year instead of the three to five years that it currently takes.
Teaching people about clinical trials and then developing an easy system for people to locate them are a few of the issues cancer patient advocates have tackled to improve clinical trial participation. In 1996, cancer patient advocates joined patient advocates representing a variety of diseases and coalitions. They went to work on many fronts to build the grass roots support they would need to lobby for a public access clinical trials database. One of the fronts was the U.S. Congress. They approached the Congress, as the FDA Modernization Act was being negotiated. They lobbied to have a provision added to this legislation that would require every clinical trial sponsor investigating the efficacy of a drug in a serious disease to list that clinical trial in a government sponsored public access database. Their lobbying effort was successful when section 113 was included in the 1997 FDA Modernization Act.
The FDA does not administer the ClinialTrials.gov database, but rather it was developed and is managed by the National Library of Medicine. On August 23, 2004, a total number of 5,841 trials for serious diseases were listed and open to enrollment with the following sponsorship: 3,019 – NIH, 808 – pharmaceutical companies, 1821 – academic medical centers, and 193 – other federal agencies.
Of this total, 3,561 cancer clinical trials were listed and open to enrollment with the following sponsorship: 1537 – NIH, 388 Ð pharmaceutical companies, 1620 – academic medical centers, and 16 – other federal agencies.
The clinical trial database is growing and has come a long way. In 1994, there were only 24 pharmaceutical company cancer trials listed in the National Cancer Institute’s database. Today there are 388 drug company sponsored cancer clinical trials in ClinicalTrials.gov. And yet, in a 2002 study conducted by the FDA, only 48 percent of the cancer clinical trials that should have been listed in ClinicalTrials.gov are in the database.
Due to the commercial secrecy that often surrounds drug development, some drug companies appear to be hesitant to make the public aware of their research trials because they fear their competitors will find out what they are up to. In cancer, some estimate that more than 50 percent of cancer research is being conducted by the pharmaceutical industry. Some estimates are as high as 70 percent.
At the same time, patient recruitment remains a costly problem for drug companies. According to CenterWatch, a publisher focused on clinical trials, 78 percent of all trials are delayed by problems in recruiting patients, with 12 percent facing delays of more than six months.
Patients with serious diseases want to know only a few basic things when they are looking for clinical trial information:
*The purpose and objective of the trial,
*The patient eligibility information,
*The location of the trials, and
*Who they can contact to discuss enrollment.
This is precisely the information the FDA law requires trial sponsors to include in their ClinicalTrial.gov listing.
Once a trial is identified, a call to the trial site can be made to ask a few questions such as, Is the trial still recruiting patients? and Is the patient eligible for the trial? Depending on the answers to those questions, the patient may decide to take the next step and discuss that trial with his or her doctor.
For the pharmaceutical industry, I believe that this database is an invaluable opportunity to inform the public about their trials, which could mean speedier recruitment for their clinical trials. Patient recruitment is time consuming and thus a very costly component of drug development.
For scientists and academics, this database can be used to quickly understand the clinical trials underway in their field, thus avoiding duplication of expensive research.
For patients with life threatening diseases faced with complicated treatment choices, this database now gives them the option of considering a clinical trial – a trial they might not know about without access to ClinicalTrials.gov.
Reprinted with permission of Coping magazine.
Learn more about the Clinical Trials Information Service.
