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Improving the Institutional Submission and Approval Process for Clinical Research Protocols in Oncology

Phase I Program, Breast Medical Oncology, Division of Cancer Medicine, University of Texas M.D. Anderson Cancer Center, Houston, TX

To the Editor:

Dilts and Sandler address a critical component of clinical cancer research.¹ Drug development in oncology is lengthy and expensive.² Multiple steps in the activation of clinical trials are indeed critical for this process and may generate unnecessary delays and increased costs to the overall research. Hence, as proposed by the authors, the identification of obstacles particular to each group and institution pose innumerable opportunities to decrease the costs and time to conduct clinical cancer studies while maintaining utmost scientific integrity. Similar to the initiative discussed by Dilts and Sandler, although in much lesser detail, our program has begun to formally evaluate the process for protocol activation in our institution in an attempt to improve negotiations, time to activation, patient accrual, and publication³ of each of our trials. A review of the first 31 industry-sponsored phase I trials activated during the first 3 years of our program (n = 31) was carried out to evaluate the time to institutional review board approval and first patient enrollment (Table 1) . We have also identified the most common invisible obstacles in our activation process (Table 2). However, in our experience, an active coordinating team, very close and continued communication with the various institutional regulatory bodies, and a heavily vested protocol champion at our site (the principal investigator) and on the sponsor's end is thus far the most efficacious strategy to expedite the multiple steps that Dilts and Sandler very eloquently describe. Another potential way to accelerate this procedure includes a parallel approach in which the submission/approval process is carried out concomitantlywith the budget and contract negotiations (levels 2 and 3 of Fig 1 in the article by Dilts and Sandler).¹

AUTHORS’ DISCLOSURES OF POTENTIAL CONFLICTS OF INTEREST

The authors indicated no potential conflicts of interest.

ACKNOWLEDGMENTS

Supported in part by National Cancer Institute Grant No. UO1 CA062461 10.

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. Lengauer C, Diaz LA Jr, Saha S: Cancer drug discovery through collaboration. Nat Rev Drug Discov 4:375-380, 2005[CrossRef][Medline]

3. Camacho LH, Bacik J, Cheung A, et al: Presentation and subsequent publication rates of phase I oncology clinical trials. Cancer 104:1497-1504, 2005[CrossRef][Medline]

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