LINK TO MEMBERS ONLY CLINICAL TRIAL WEBPAGE
MCC Clinical Trial Metrics Steering Committee - Reconvening Work Groups and Launching Process Improvement WG (9.11.09)
The MCC Clinical Trial Metrics Steering Committee has reviewed the industry feedback about the MCC Clinical Trial Performance Metrics (beta version), released for industry review in April. We fielded numerous inquiries about the metrics and received good feedback from the industry that we are looking forward to sharing with the work groups.
In addition to reconvening the original five work groups, we are adding a new work group tasked with bringing together people with process improvement expertise. The Process Improvement work group will work with the other five work groups to help make the metrics a useful tool for improving process effectiveness and efficiency.
Please contact Linda Sullivan for additional information.
MCC released Clinical Trial Performance Metrics (beta version) for industry feedback
In April 2009, the MCC invited non-MCC members to review the MCC Clinical Trial Performance Metrics (beta version) and provide feedback to us via an online survey tool. The MCC Clinical Trial Metrics Steering Committee and Working Groups are reviewing respondents' feedback while they are finalizing the Clinical Trial Performance Metrics (version 1.0), expected to be released in April 2010.
Background information about the MCC, the metrics development process as well as a description of each metric is included in the MCC Clinical Trial Performance Metrics (Beta version) document [pdf].
On the behalf of the entire MCC CRO Steering Committee, I would like to announce that after much discussion among the MCC Board of Directors and Steering Committee members, the MCC has decided to change the name of the metrics being developed by our group from CRO performance metrics to Clinical Trial performance metrics.
During the metrics development process, some MCC member organizations expressed concern that labeling the metrics as “CRO performance metrics” implies that only CROs are accountable for the performance being measured. Some of our metrics measure the joint performance of sponsors, sites and/or CROs. We believe that the new name reflects the collaborative nature of the metrics.
Overall, the Clinical Trial Metrics initiative has made much progress over the last 12 months. The metrics have been developed within five working groups:
1. Biometrics (includes Biostatistics and Data Management)
2. Business Operations/Finance,
3. Clinical Operations (includes Project Management and Medical Writing),
4. Drug Supply
5. Quality Assurance/Regulatory Affairs/Safety
The Clinical Trial Performance Metrics (beta version) will be released and discussed in breakout groups at the IIR Partnerships with CROs conference on April 28th. We will gather feedback from the industry (MCC members and non-members) in the following months and revise the metrics, as needed. We anticipate being able to release Clinical Trial Performance Metrics (version 1.0) before the end of 2009.
I hope to see you at the IIR Partnerships with CROs meeting in Orlando, FL.
Cory Gutterman
Chair, Clinical Trial Metrics Steering Committee
MCC CRO Performance Metrics Work Groups Kick-Off Session 5.19.2008 [pdf] [Streaming recording link] [Download recording link]
MCC CRO Performance Metrics Survey 4.14.2008 [pdf]
MCC CRO Performance Metrics Steering Committee Seeking Work Group Participants
We would like to extend an invitation to you and your colleagues to participate in the new MCC CRO Performance Metrics initiative. Our goal for this initiative is to:
· Develop metrics to improve clinical trial operations including sponsor, CRO and site processes. Metrics should be developed for the purpose of identifying “what works” and “what needs improvement”.
· Provide the ability to utilize metric data as an information and discussion tool for sponsor and CRO decision makers; drive change as appropriate.
These metrics will provide Sponsors and CROs a baseline set of metrics with a clear explanation of what the metrics mean, how they were derived and how each company can use the metrics to improve efficiency.
The CRO Performance Metrics Steering Committee would like to identify individuals from your company to participate in working groups. Work group participants can expect to spend 3-5 hours per month on work group activities over the next 6-8 months. The table below outlines the areas of interest for each of the five work groups.
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Biometrics WG |
Biostatistics: Defined as process and activities related to the analysis of data. For example, development of the statistical analysis plan, creation of SAS programs, data listings, tables, and figures |
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Data Management: Defined as processes and activities related to the input of data into a database to be used for statistical analysis of the clinical trial, such as data validation plan, query management, edit check specifications, CRF design and production. Can also include EDC, lab data, patient reported outcomes, IVRS data, etc. |
|
Business Operations WG |
Business Operations: Defined as process and activities that are required as part of the clinical trial but are not generally governed by SOPs and Regulations. Examples include bidding process, contract process, investigator agreements, etc. |
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Finance: Defined as processes and activities related to project funding, invoicing and payment, spend Vs. budget, etc. |
|
Clinical Operations WG |
Clinical Operations: Defined as processes and activities related to the monitoring and site management of the clinical trial including trip reports, patient recruitment, patient enrollment, etc. |
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Medical Writing: Includes but is not limited to protocol drafting, protocol writing, clinical study report, ISS, ISE, manuscripts/publications |
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Project Management: Defined as processes and activities related to the overall management of the clinical trial with particular attention to management of timelines and deliverables. |
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Drug Supply WG |
Drug Supply: Defined as process and activities related to the supply of study product to sites. May include IVRS, packaging, labeling, shipment, import/export licenses, other clinical supplies, insurance. |
|
QA, Regulatory & Safety WG |
Quality Assurance: Activities related to the assessment of quality related to the conduct of the clinical trial. Includes but is not limited to supplier audits, clinical site audits, protocol audits, database audits |
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Regulatory Affairs: Activities related to drug release, IRB submissions, MOH submissions IND annual update reports, CTA and IND filings and PSURs. |
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Safety: Defined as processes and activities related to fulfilling IND safety reporting obligations such as IND safety reports, MedWatch/CIOMS reports. Also includes reporting of adverse events, creation of narratives for SAE, etc. |
Special note: Information Technology will be included across the work groups. Information technology may include systems required for conduct of the clinical trial (e.g. Clinical Trial Management Systems, IVRS, EDC systems). Focus is on the system and its performance rather than on the data itself.
Please note that any given individual may participate in one or more work groups. In addition, multiple individuals from the same company may participate in a single work group. Work group participants must be employed by a MCC member organization.
We look forward to working with all of you on this important initiative and hope you will decide to join a MCC CRO Performance Metrics work group. Please complete an online work group registration form [click here to link to form] or contact Linda Sullivan (lsullivan@metricschampion.org) if you are interested in joining a CRO work group.
Thank you,
MCC CRO Steering Committee
|
Cory Gutterman (Chair) |
Abbott |
|
Ed Cannon |
AstraZeneca |
|
Beenu Kapoor |
Covance |
|
Holly Hankins |
Eli Lilly |
|
Colleen McCoy
Kathe Balinski |
Genentech
Medarex |
|
Magaly Woolard |
Merck |
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April Davis |
Perceptive Informatics |
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Julie Szabo |
PharmaNet |
|
Lorraine Waring
Monika Frey |
Pfizer
Quintiles |
|
Paul Shin |
Valeant |
For additional information, please review the MCC CRO Metrics Initiative Brief.