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Clinical Trial Investigator Status: You Need to Earn It

Helen F. Graham Cancer Center at Christiana Care, Newark, DE

The clinical trials that are conducted by the National Cancer Institute (NCI) represent the core of the clinical program of the NCI's Center for Cancer Research. At the Center for Cancer Research, clinical and basic science are integrated with the goal of reducing the burden of cancer through discovery, exploration, and bench-to-bedside translational treatment and prevention modalities. The goal of the NCI clinical trials program is to answer questions about particular cancers and to identify new therapeutic and prevention interventions, which are performed across the United States at centers participating in NCI-supported research.

Sadly, only 2% to 7% of adult patients with cancer across the United States participate in these clinical trials.^1-3 To make matters worse, the following populations are under-represented among participants in NCI-funded clinical trials: Latinos/Hispanics, Asian and Pacific Islanders, African American men, American Indians/Alaskan Natives, adolescents, older adults (age 65 years), individuals who reside in rural areas, and individuals of low socioeconomic status.⁴ The lack of diversity in clinical trials populations reduces the opportunity for discovering effects that may be relevant to a particular under-represented population.^5,6 The literature has focused on barriers to participation in clinical trials—including both physician and patient issues—such as cost, lack of support personnel, limited access to clinical trials, and the distance that patients may live from centers that participate in NCI clinical trials. In a study by Meropol et al,⁷ cognitive, affective, and practical barriers to participation in clinical treatment trials were characterized among Pennsylvania oncologists. Eligible physician participants were practicing medical oncologists in Pennsylvania, and eligible patients were adults at least 18 years of age with cancer undergoing follow-up by medical oncologists in Pennsylvania. Of 137 oncologists and 170 patients who completed the surveys, of patients, 84% were aware of clinical trials, and both oncologists and patients generally agreed that clinical trials were important to improve cancer treatment. It was interesting that oncologists and patients in this report were more likely to consider clinical trials in advanced or refractory disease. When considering seven potential barriers to clinical trials, random assignment and fear of receiving a placebo were highly ranked by both patients and oncologists. Patients identified fear of adverse effects as the greatest barrier to clinical trial participation, whereas oncologists ranked this psychosocial barrier as of least importance to their patients. Although the study found that oncologists and patients in Pennsylvania were aware of clinical trials and had favorable attitudes toward them in principle, psychosocial barriers existed for patients that more than likely reduced participation. One of the key issues in this study was the fact that the oncologists who were surveyed had favorable attitudes toward clinical trials. Surely, there must be oncologists who don’t have favorable attitudes toward clinical trials and are not advocates of clinical trials. This is reflected in the fact that 30% of oncologists are responsible for 70% of the accrual to NCI clinical trials. Although some important pragmatic issues, such as fiscal and administrative support, may affect participation, these are issues that affect all oncologists to varying degrees, yet some oncologists are more successful than others in accruing patients to clinical trials.

As reported by the Coalition of Cooperative Groups, community-based practices are responsible for 64% of adult patients accrued in cooperative group–sponsored clinical trials. Academic centers are responsible for 34%, whereas military/Veteran's Administration hospitals contribute the remaining 2%.⁸ Hence, the NCI Community Clinical Oncology Programs (CCOPs) play a major role in adult recruitment to NCI-sponsored clinical trials. Created in 1983 by the National Cancer Institute, the CCOP network allows patients and physicians to participate in state-of-the-art clinical trials for cancer prevention and treatment in their local communities. There are 50 CCOPs and 13 minority-based CCOPs currently funded in 35 states across the United States, the District of Columbia, and Puerto Rico.

The Delaware Christiana CCOP was initially funded in 1987. After a restructuring of the cancer program at the Helen F. Graham Cancer Center at Christiana Care in 2001, accrual to NCI clinical trials increased from 9.9% in 2001% to 20% in 2006. There are many reasons for this dramatic increase in clinical trial accrual over a 5-year period, which represents six times the national average. All the reasons for this increase in patient accrual to NCI clinical trials are beyond the content of this article. Briefly, however, this increase has been partly due to the establishment of multidisciplinary disease site centers, placing clinical research nurses in the private practice offices, with a continuous marketing campaign. Nevertheless, despite the improvement of this clinical trials accrual, there is a core of physicians participating in the cancer program whose track record to clinical trial accrual can best be described as dismal. This is despite the fact that there are more than 110 clinical trials available for their patients covering every disease site, with personnel support to help in the recruitment to clinical trials. These individuals are designated members of the NCI Cooperative Groups and many have membership in cooperative groups on their curriculum vitaes.

Some investigators have suggested that access to clinical trials should be an objective⁹ and a component of state-of-the-art cancer care.¹⁰ This brings us to the point of the title of this article. Shouldn't the status of a clinical trials investigator mean something and have credibility? We believe the answer is a definitive "yes." It seems unfair to consider on the same level a clinical trials investigator who recruits a significant number of patients to NCI clinical trials each year to another clinical trials investigator whose clinical trial accrual is one patient or fewer a year. This is especially true when resources are given to both types of investigators with minimal payback from the latter type of investigator. We feel there needs to be equity in the system, especially for participation in those clinical trials dealing with the most common cancers that oncologists see in the United States. To be designated a clinical trials investigator and to have respect in clinical cancer research, one must earn it.

Therefore, the Helen F. Graham Cancer Center put into place criteria to define a clinical trials investigator who participates in NCI-sponsored clinical trials. It is important to know that the precedent for this has already been established by the Southeast CCOP under the direction of Jim Atkins, MD. Although our criteria differ from the Southeast CCOP, we are encouraging other CCOPs to establish criteria for defining a clinical trials investigator participating in NCI clinical trials.

As of January 2008, the Helen F. Graham Cancer Center at Christiana Care established the following criteria for the status of an NCI Clinical Trials Investigator participating in our CCOP:

1. Clinical trials investigators are required to recruit to NCI clinical trials a minimum of four patient accruals per calendar year. These patient accruals can be to treatment or cancer control or prevention trials.
   
2. Clinical trials investigators are strongly encouraged to attend a minimum of one NCI Cooperative Group or CCOP research base meeting every other year.
   
3. If four patients per calendar year are not accrued, the physician will lose CCOP investigator status, but will be expected to continue to submit follow-up data on all patients as required. The following requirements must be met for reinstatement as a clinical trials investigator:
   1. A 1-year waiting period.
      
   2. A letter of intent from the investigator to the principal investigator of the CCOP stating renewed interest in research participation.
      
   3. Completion of the NCI membership application, with a membership fee of $500.00
      
   4. Attendance of an NCI cooperative group or CCOP research base meeting.
      
   
   
4. All clinical trials investigators will undergo a medical records internal audit as part of preparation for NCI Cooperative Group site visits. These will be performed monthly by the Medical Director of the Helen F. Graham Cancer Center and the principal investigator of the CCOP or an extramural auditor.
   

We feel that these criteria will allow us to focus our resources more efficiently and increase our accrual rate to NCI clinical trials to 30% over the next 3 to 4 years. This process also establishes credibility for physicians as NCI clinical trials investigators. The criticism of this program could be that one may be denying patients access to clinical trials even if a physician only accrues one patient a year. However, we feel that by giving the status of a clinical trials investigator credibility, patients will seek out NCI clinical trial investigators and not lose the opportunity of participation in a clinical trial. We feel that we and the patients have nothing to lose and everything to gain. We encourage other institutions to establish similar criteria in an effort to increase the national accrual rate to NCI cancer treatment, cancer control, and prevention trials.

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

Although all authors completed the disclosure declaration, the following author(s) indicated a financial or other interest that is relevant to the subject matter under consideration in this article. Certain relationships marked with a "U" are those for which no compensation was received; those relationships marked with a "C" were compensated. For a detailed description of the disclosure categories, or for more information about ASCO's conflict of interest policy, please refer to the Author Disclosure Declaration and the Disclosures of Potential Conflicts of Interest section in Information for Contributors.

Employment or Leadership Position: Kandie Price, Cancer and Leukemia Group B (CALGB) (U) Consultant or Advisory Role: None Stock Ownership: None Honoraria: None Research Funding: None Expert Testimony: None Other Remuneration: None

AUTHOR CONTRIBUTIONS

Conception and design: Nicholas J. Petrelli, Stephen Grubbs, Kandie Price

Administrative support: Kandie Price

Manuscript writing: Nicholas J. Petrelli, Stephen Grubbs, Kandie Price

Final approval of manuscript: Nicholas J. Petrelli, Stephen Grubbs, Kandie Price

REFERENCES

1. Klabunde CN, Springer BC, Butler B, et al: Factors influencing enrollment in clinical trials for cancer treatment. South Med J 92:1189-1193, 1999[CrossRef][Medline]

2. Friedman MA, Cain DF: National Cancer Institute sponsored cooperative clinical trials. Cancer 65:2376-2382, 1990 (suppl)[CrossRef][Medline]

3. Go RS, Frisby KA, Lee JA, et al: Clinical trial accrual among new cancer patients at a community-based cancer center. Cancer 106:426-433, 2006[CrossRef][Medline]

4. Sateren WB, Trimble EL, Abrams J, et al: How sociodemographics, presence of oncology specialists, and hospital cancer programs affect accrual to cancer treatment trials. J Clin Oncol 20:2109-2117, 2002[Abstract/Free Full Text]

5. Swanson GM, Bailar JC 3rd: Selection and description of cancer clinical trials participants: Science or happenstance? Cancer 95:950-959, 2002[CrossRef][Medline]

6. Moser M, Lunn J: Responses to captopril and hydrochlorothiazide in black patients with hypertension. Clin Pharmacol Ther 32:307-312, 1982[Medline]

7. Meropol N, Buzaglo JS, Millard J, et al: Barriers to clinical trial participation as perceived by oncologists and patients. J Natl Compr Canc Netw 5:655-664, 2007[Medline]

8. Coalition of Cancer Cooperative Groups: Baseline study of patient accrual onto publicly sponsored U.S. cancer clinical trials: An analysis conducted for the global access project of the National Patient Advocate Foundation. Philadelphia, PA, Coalition of Cancer Cooperative Groups, 2006

9. Tejeda HA, Green SB, Trimble EL, et al: Representation of African-Americans, Hispanics, and whites in National Cancer Institute cancer treatment trials. J Natl Cancer Inst 88:812-816, 1996[Abstract/Free Full Text]

10. Outlaw FH, Bourjolly NJ, Barg FK: A study on recruitment of black Americans into clinical trials through a cultural competence lens. Cancer Nurs 23:444-451, 2000[CrossRef][Medline]

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