# Presentation: 027761

## National Cancer InstituteClinical Trials Working GroupNCAB UpdateJames H. Doroshow, M.D.DirectorDivision of Cancer Treatment and DiagnosisSeptember 15, 2004

## Clinical Trials Working Group: Progress  

**Review of Armitage, Implementation, and P30/P50 reports****	**
**Prioritized major issues currently impairing optimal clinical trials conduct on which the CTWG would focus**
**Established through numerous conference calls and face-to-face meetings process for addressing these issues**

## Current Cancer Clinical Trials System:What Are Major Issues To Work On?

**Lack of uniformity and standardization of clinical trials procedures and infrastructure**
**Clinical trials research is not coordinated either across the multiple venues in which it is carried out or by its mechanism of support**
**Mounting regulatory burdens and limited interface between the clinical research community, NCI, FDA, CMS, OHRP, and PHARMA**
**Increasingly sophisticated scientific requirements for trials to maximize the efficacy of novel therapies**
**Protracted time frame for trial implementation and completion**
**Fragmented, often duplicative, and competing national effort to study adult cancers**

## CTWG: Working Subcommittees

**Standardization of clinical trial procedures and infrastructure**
**Coordination of clinical trials across Cancer Centers, Spores,PO1s, and Cooperative Groups**
**Enhancing interactions between the clinical ****	****research community, NCI, Pharma, FDA,**
**	****	****regulatory agencies, and patient advocates**
**Developing core facilities to improve scientific ****	****support for trials**
**Improving clinical trial accrual management**
**Refining the protocol prioritization process**

## Priority Issues for CTWG

_**Subcommittees**_
**Standardization & Infrastructure**
**Coordination across venues**
**NCI, Industry, Regulatory, Advocate interactions**
**Core Facilities**
**Accrual Management**
**Protocol Prioritization**

_**Chairs & NCI Representatives**_
**Parkinson****, Adamson, Schnall; M. Christian, Buetow**
**Johnson****, Alberts, Abeloff; Antman**
**Pazdur****, Tunis, Averbuch; Abrams**
**Appelbaum****, Begg; Doroshow**
**Schilsky****; Zweibel**
**Abbruzzese****, Ratain; Fine**

**Encourage active input from the extramural community as**
**recommendations and action items developed**

## Standardization of Clinical Trial Procedures and Infrastructure: Issues

**Define acceptable clinical trial standards for:**
**Personnel—credentialing (cra’s, investigators)**
**Institutions—pharmacy, contract language, tissue**
**Content—CRF’s, endpoints, data requirements, CDE’s**
**Process—Q/A and Q/C, inventories, imaging**

_***GOAL: ***__**Create specifications for infrastructure**_

## Coordination of Clinical Trials Across Centers, SPORES, PO1’s, and Cooperative Groups: Issues

**Communication and inventories**
**What studies are open where? What is the accrual rate?**
**Incompatible data bases, even within the same institution**
**Duplication and underutilization**
**Multiple tumor banks for SPORES and Ca Centers in same**
**	****facility**
** ****Poor alignment of incentives**
**Multicenter versus individual Ca Center or SPORE**
**trials**
**Team science with facile handoffs amongst funding**
**mechanisms versus traditional investigator-initiated**
**activities**
**High “value” versus high “reimbursement” studies**

_***GOAL: ***__**To create vehicles for communication and **_
_**to foster cooperation**_

## Enhance Interactions Between Clinical Trials Community, NCI, Pharma, FDA, Regulatory Agencies, and Advocates: Issues

**Need to get all stakeholders together for early**
**evaluation of drug development plans—Pharma,**
**NCI, FDA, clinical trials community**
**Need to understand global pattern of clinical trials**
**and drug development efforts**
**How to convince Pharma to do registration trials**
**with Coop Grp-type data—audits, quantity**
**Interactions with CMS to provide “label information”**
**not just indications in face of coming requirement **
**for trials to substantiate off-label usage**
**Create FDA/NCI/Pharma course in drug development**
**to promote best practices  **

_***GOAL: ***__**Create culture of early regulatory consultation**_

## Developing National Core Facilities to Improve Scientific Support for Trials: Issues

**Current status of core facilities to support **
**clinical trials on a **_**national basis**_
**Unmet needs**
**Potential structure of virtual cores**
**How to develop and support**
**Possible examples**
**-outcomes (economic, long-term complications)**
**-proteomics**
**-pharmacogenomics**
**-molecular pathology**

_***GOAL: ***__**Enhance scientific infrastructure for trials**_

## Improving the Management
of Clinical Trial Accrual: Issues

**of Clinical Trial Accrual: Issues**

**Clinical trial accrual rates too low; emphasis **
**	****on developing trials rather than on **
**	****managing accrual [vs. Pharma]**
**Evaluate systems problems: **
**-resource utilization**
**-data collection  burden**
**-competition for trials and patients**
**Evaluate site problems:**
**	****-protocol availability and **
**	****-dissemination to research team**
**	****-strategy for enrollment**
**	****-investigator preference issues**

_***GOAL: ***__**Create systems/environment to speed accrual**_

## Refining the Protocol Prioritization Process: Issues

**Need **_**ongoing**_** & **_**dynamic**_** strategic prioritization process:**
**	**
**	****-****disease-oriented, including orphan diseases, across a broad**
**	****	****continuum of trial efforts**
**	****-drug/biologic-oriented**
**	****-modality-oriented**
**	****-facile, more fluid than currently- available, crosses all**
**	****	****relevant clinical trials venues and able to communicate**
**	****	****critical priorities to entire community**
**	****-evolution from gatekeeper model to collaborative planning**
**	****	****and review**
**	****-provides incentives for collaborative science **

_***GOAL: ***__**Improve effectiveness and efficiency**_

## Next Steps

**Bi-weekly Conference calls**
**Monitoring check-in points**
**Posting of subcommittee structure & activities ****	****on CTWG web site:  ****	****[http://integratedtrials.nci.nih.gov]**
**	****for comment by clinical trials community**
**Presentation of progress at each NCAB ****	****meeting**
***Goal: ***_**Recommendations for NCAB by June 2005**_