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Better outcome not guaranteed for cancer research volunteers
Does taking part in a controlled clinical trial of cancer therapy improve one’s chances of surviving that disease?
The U.S. authors of a report in the Jan. 24 issue of The Lancet dispute the widely held belief that people with cancer who take part in clinical trials have better treatment outcomes. Its title: "Comparison of outcomes in cancer patients treated within and outside clinical trials: Conceptual framework and structured review." The medical oncologists who tested the supposition are at the Dana-Farber Cancer Institute in Boston.
The group surveyed 26 previously published studies that compared the health outcomes of cancer patients enrolled in clinical trials vs. those not enrolled. Although 14 of their studies suggested a beneficial health outcome for trial participants, most studies did not effectively control for bias. For example, only nine studies required the same entry criteria for participating and nonparticipating patients. Only three of those found that trial participants had better outcomes than nonparticipants.
After developing a conceptual framework for comparison of trial and nontrial patients, they did a comprehensive literature search to identify studies comparing outcomes between those groups. They identified 26 comparisons from 24 published articles of outcomes among cancer patients enrolled and not enrolled in clinical trials.
Of those, 21 comparisons used retrospective cohort designs; 14 comparisons provided some evidence that patients enrolled in trials have improved outcomes. Only eight comparisons restricted nontrial patients to those meeting trial eligibility criteria. Of those, three reported better outcomes in trial patients than in nontrial patients.
The American Federation of Clinical Oncology Societies maintains that treatment in a clinical trial often is a cancer patient’s best chance of survival, and that trial access is one of the "basic requirements of quality cancer care." Such claims suggest that trials are viewed not only as a way to improve future treatment, but also as the best therapy for current patients.
FDA wants clinical trial database improvements
The Food and Drug Administration (FDA) wants to better assist patients who have serious or life-threatening diseases access investigational treatments by improving its database of clinical trials.
Patients who cannot be treated with existing therapies or who do not meet eligibility requirements for certain drugs can gain information about ongoing clinical trials via the FDA’s Clinical Trials Data Bank. The agency is looking for ways to increase and improve the information available and is asking interested parties to comment on proposals related to providing the information in a more straightforward and efficient way.
For example, the agency has established a web-based system in which firms can submit clinical trial information electronically. Companies are asked to submit a description of the location of the trial sites and a point of contact.
Once the information is entered, studies will be available to the public on ClinicalTrials.gov within two to five days. Information contained in the Data Bank is considered part of a long-term registry, which will remain available through accrual, analysis and even after the product is approved.
Beyond basic information about a trial, the agency encourages firms to submit more detailed notes including projected enrollment as well as information about other trials under the IND, such as trials for a disease or condition that is not serious or not designed to test effectiveness.
The entire proposal is available on the Federal Register’s web site (www.gpoaccess.gov/fr/index.html ; Jan. 27, 2004; 69(17): 3,923-3,925.). Comments and suggestions will be accepted through March 27 via U.S. mail at the Division of Dockets Management, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
BRAAN gets smarter
In the December 2003 issue of Clinical Trial Administrator, we ran a profile on Baylor College of Medicine’s integrated system for institutional review boards — BRAAN. API, the company that markets BRAAN to the public, now offers BRAAN 2. According to API, the new product features expanded flexibility, which clients were asking for. Staff now can add, delete, or modify questions, sections, or entire forms. BRAAN 2 also can be used beyond the compliance office, offering study data management for both animal and human protocols. For information, visit: www.apibraan.com.