CME: Analyzing Access to Cancer Trials

CME: Analyzing Access to Cancer Trials
Author Information (click to view)

Matthew D. Galsky, MD

Associate Professor of Medicine
Director of Genitourinary Medical Oncology
Icahn School of Medicine at Mount Sinai

Matthew D. Galsky, MD, has indicated to Physician’s Weekly that he has no financial disclosures to report.

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Target Audience (click to view)

This activity is designed to meet the needs of physicians.

Learning Objectives(click to view)

Upon completion of the educational activity, participants should be able to:

 

  • Discuss the findings of an analysis that estimated the geographic accessibility of clinical trials for advanced cancer in the United States.

Method of Participation(click to view)

Statements of credit will be awarded based on the participant reviewing monograph, correctly answer 2 out of 3 questions on the post test, completing and submitting an activity evaluation.  A statement of credit will be available upon completion of an online evaluation/claimed credit form at www.akhcme.com/pwMay02.  You must participate in the entire activity to receive credit.  If you have questions about this CME/CE activity, please contact AKH Inc. at dcotterman@akhcme.com.

Credit Available(click to view)

AKH

CME Credit Provided by AKH Inc., Advancing Knowledge in Healthcare

Physicians
This activity has been planned and implemented in accordance with the Essential Areas and policies of the Accreditation Council for Continuing Medical Education (ACCME) through the joint providership of AKH Inc., Advancing Knowledge in Healthcare and Physician’s Weekly’s.  AKH Inc., Advancing Knowledge in Healthcare is accredited by the ACCME to provide continuing medical education for physicians.

 

AKH Inc., Advancing Knowledge in Healthcare designates this enduring activity for a maximum of 0.5 AMA PRA Category 1 Credit(s)™.  Physicians should claim only the credit commensurate with the extent of their participation in the activity.

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Disclosures(click to view)

It is the policy of AKH Inc. to ensure independence, balance, objectivity, scientific rigor, and integrity in all of its continuing education activities. The author must disclose to the participants any significant relationships with commercial interests whose products or devices may be mentioned in the activity or with the commercial supporter of this continuing education activity. Identified conflicts of interest are resolved by AKH prior to accreditation of the activity and may include any of or combination of the following: attestation to non-commercial content; notification of independent and certified CME/CE expectations; referral to National Author Initiative training; restriction of topic area or content; restriction to discussion of science only; amendment of content to eliminate discussion of device or technique; use of other author for discussion of recommendations; independent review against criteria ensuring evidence support recommendation; moderator review; and peer review.

Disclosure of Unlabeled Use & Investigational Product(click to view)

This educational activity may include discussion of uses of agents that are investigational and/or unapproved by the FDA. Please refer to the official prescribing information for each product for discussion of approved indications, contraindications, and warnings.

Disclaimer(click to view)

This course is designed solely to provide the healthcare professional with information to assist in his/her practice and professional development and is not to be considered a diagnostic tool to replace professional advice or treatment. The course serves as a general guide to the healthcare professional, and therefore, cannot be considered as giving legal, nursing, medical, or other professional advice in specific cases. AKH Inc. specifically disclaim responsibility for any adverse consequences resulting directly or indirectly from information in the course, for undetected error, or through participant’s misunderstanding of the content.

Faculty & Credentials(click to view)

FACULTY DISCLOSURES

Keith D’Oria – Editorial Director
Discloses no financial relationships with pharmaceutical or medical product manufacturers.
Matthew D. Galsky, MD
Discloses no financial relationships with pharmaceutical or medical product manufacturers:
AKH and PHYSICIAN WEEKLY’S STAFF/REVIEWERS

Dorothy Caputo, MA, BSN, RN- CE Director of Accreditation
Discloses no financial relationships with pharmaceutical or medical product manufacturers.

AKH planners and reviewers have no relevant financial relationships to disclose.

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Matthew D. Galsky, MD (click to view)

Matthew D. Galsky, MD

Associate Professor of Medicine
Director of Genitourinary Medical Oncology
Icahn School of Medicine at Mount Sinai

Matthew D. Galsky, MD, has indicated to Physician’s Weekly that he has no financial disclosures to report.

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A study suggests that innovative approaches are needed to improve the geographic accessibility of clinical trials for patients who have advanced cancer in the United States.
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Data that are derived from clinical trials help in the development of critical evidence that is necessary to guide patient care for people with cancer. Experts typically endorse this concept, and some practice guidelines have gone so far as to say that the management of patients with cancer can be optimized when conducted in a clinical trial setting.

“Research suggests that only about 3% to 5% of cancer patients in the United States participate in clinical trials, but more participation is needed,” says Matthew D. Galsky, MD. “With few patients participating in trials, the generalizability of the results become questionable.” Poor accrual to clinical trials may also impede the pace of progress when treating particular patients with cancer and could potentially have an impact on the cost of drug development.

Studies have identified several barriers to improving the enrollment of cancer patients into clinical trials, but Dr. Galsky says more research is needed to find interventions that are designed to overcome these hurdles. “Previous research has concentrated on patient awareness of trials and their willingness to participate in them,” he says. “We need to further explore geographic barriers to participation in clinical trials in order to assess availability and access.” He adds that recent survey results suggest that most patients with cancer are not willing to travel significant distances to participate in clinical trials.

 

A Look at Geographic Accessibility

In a research letter published in JAMA Internal Medicine, Dr. Galsky and colleagues conducted an analysis to estimate the geographic accessibility of clinical trials for advanced cancer in the U.S. Using data derived from ClinicalTrials.gov, the authors reviewed information regarding clinical trials and the associated sites of these trials. They identified all actively accruing trials that evaluated first-line treatments for metastatic breast, prostate, colorectal, and non–small cell lung cancers. The research was limited to these disease-specific sites because they rank among the most commonly diagnosed and most frequent causes of cancer-related mortality in the U.S.

“This is a challenging topic to study because many clinical trials are going simultaneously throughout the country at any given time, making it a moving target,” says Dr. Galsky. “Fortunately, the government has mandated registration of clinical trials on ClinicalTrials.gov. Therefore, we have a comprehensive registry of trials from which to analyze the clinical trial enterprise at large.”

 

Examining Drive Time

According to the results, about half of patients with metastatic breast, prostate, and colorectal cancer would need to drive more than 1 hour in one direction in order to access a clinical trial site in the U.S. For metastatic non–small cell lung cancer, the rate was slightly lower at about 38% (Table). Several regions were generally associated with the longest travel times, including:

  • Mountain regions.
  • West North Central regions.
  • West South Central regions.

“Our findings support the notion that geographic barriers do exist when it comes to clinical trial participation among patients with cancer,” Dr. Galsky says.

In 2010, the Institute of Medicine released a report noting that clinical trial sites are often selected based on the geographic location of where investigators conducting the study are located. Dr. Galsky says clinical trial access for patients with advanced cancer can improve if it was extended to regions based on where patients live. “The further patients must travel, the more difficulties it creates in recruiting patients to participate,” he says. “Efforts are needed to ensure better access to trials based on geographic proximity.”

 

Future Research

Dr. Galsky says that one approach to improve geographic access to clinical trials for patients with advanced cancer is telemedicine. “Research suggests that telemedicine can enhance outcomes among various groups of patients, such as those who present for care at ICUs that have limited capabilities,” he says. “It may be possible to apply this same model to clinical trials for cancer and other diseases.” Dr. Galsky and his team are currently conducting a pilot clinical trial replacing the vast majority of ‘in person’ study visits with telemedicine study visits to ease the burden of participation.

In future analyses, the study recommends that research be conducted to assess the minimum travel time that affects decisions made by patients with cancer regarding their medical care. It is possible that patients living in metropolitan areas have different values of traveling time than those who reside in rural areas. In addition, examining trial accessibility among patients with rarer forms of cancer may also be of benefit.

Readings & Resources (click to view)

Galsky MD, Stensland KD, McBride RB, et al. Geographic accessibility to clinical trials for advanced cancer in the United States. JAMA Intern Med. 2015;175:293-295. Available at: http://archinte.jamanetwork.com/article.aspx?articleid=1936578.

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

Murthy VH, Krumholz HM, Gross CP. Participation in cancer clinical trials: race-, sex-, and age-based disparities. JAMA. 2004;291:2720–2726.

Zarin DA, Tse T, Williams RJ, Califf RM, Ide NC. The ClinicalTrials.gov results database: update and key issues. N Engl J Med. 2011;364:852-860.

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