This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Govindarajan, R. Articles by Hutchins, L. F. Search for Related Content PubMed PubMed Citation Articles by Govindarajan, R. Articles by Hutchins, L. F.

Barriers to Clinical Trials Vary According to the Type of Trial and the Institution

University of Arkansas for Medical Sciences, Little Rock, AR

To the Editor:

The article "Barriers to Opening Oncology Clinical Trials" by Dilts and Sandler in the October 1, 2006 issue of the Journal of Clinical Oncology addresses major obstacles concerning initiation of clinical trials which are usually ignored but at the same time are very frustrating to clinical investigators.¹ We applaud the authors’ efforts in bringing to light this important issue.

The authors have described the time it takes to go through the various complex steps involved in initiating clinical trials. However, we need to bring to the attention of readers that the barriers to initiating clinical trials are not uniform for all trials as mentioned by the authors. The steps involved in opening investigator-initiated, industry-sponsored, and cooperative group trials are all different.

Investigator-initiated studies usually take longer than industry-sponsored studies and cooperative group studies because of the initial time spent in obtaining approval for the idea from the institution, the sponsoring agency, and US Food and Drug Administration. We read in this article that considerable time is spent in the initial phases of the study when a protocol is discussed among the investigators to decide on the feasibility and scientific basis for the study. US Food and Drug Administration and scientific review committee approval can have a major influence on the time it takes to open investigator-initiated studies. Industry-sponsored studies are subject to the scrutiny of the scientific review committee and institutional review board where the cooperative group studies are usually exempt from scientific review committee approval (at our institution—the University of Arkansas for Medical Sciences, Little Rock, AR) because they usually have the support and approval of the National Cancer Institute.

An added barrier for all studies is the time taken by the clinical trials office to prepare required documentation and submit it to various committees, including the additional approval required by the research and development committee of the Veterans’ Affairs hospitals if the investigators wish the protocols to be opened at those institutions.

Negotiation of budgets and contracts also are a major factor in the time needed to open clinical research studies. Also, depending on the nature of the study and the participating institution, there may be additional contracts that need to be negotiated, such as those detailing intellectual property rights.² We also need to note that community cancer centers (part of the research network reported by the authors) are not subject to scientific review committee approval and use the central institutional review board, which significantly cuts down on the time required to open trials.³

To compare the authors’ experience with the clinical trials at our institution, we have attached a table indicating the time it takes to open clinical trials at our institution (Table 1). As of October 2006, we have 175 clinical trials open for accrual. The time spent in completing the contract and budget is not available at this time. These data underscore the fact that very different time lines are at work in initiating different types of clinical trials.

The authors indicated no potential conflicts of interest.

REFERENCES

1. Dilts DM, Sandler AB: Invisible barriers to clinical trials: The impact of structural, infrastructural and procedural barriers to opening oncology clinical trials. J Clin Oncol 24:4545-4552, 2006[Abstract/Free Full Text]

2. Mello M, Clarridge B, Studdert D: Academic medical centers’ standards for clinical-trial agreements with industry. N Engl J Med 352:2202-2210, 2005[Abstract/Free Full Text]

3. American Society of Clinical Oncology: American Society of Clinical Oncology policy statement: Oversight of clinical research. J Clin Oncol 21:2377-2386, 2003[Abstract/Free Full Text]

This Article Full Text (PDF) Purchase Article View Shopping Cart Alert me when this article is cited Alert me if a correction is posted Services Email this article to a colleague Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Save to my personal folders Download to citation manager Rights & Permissions Citing Articles Citing Articles via Google Scholar Google Scholar Articles by Govindarajan, R. Articles by Hutchins, L. F. Search for Related Content PubMed PubMed Citation Articles by Govindarajan, R. Articles by Hutchins, L. F.