Electronic data capture and centralised review speed trials

According to two new surveys, use of electronic data capture is increasing during clinical trials, while a centralised review process is speeding up drug development.

Selon deux nouvelles études, l'utilisation de la capture électronique de données augmente durant les essais cliniques, tandis qu'un processus de revue centralisé accélère le développement de médicaments.

Studien zufolge nimmt die elektronische Datenerfassung bei kinischen Versuchen weiter zu, während ein zentral organisierter Überprüfungsprozess die Entwicklung von Medikamenten beschleunigt.

Preliminary findings from a new survey on electronic data capture (EDC) use in clinical trials were presented on 19th October at the Drug Information Association's (DIA) third Annual Clinical Forum in Nice, France. The survey, titled Investigational site perspectives on clinical trial information systems, is the first update to a 2001 survey published on the topic.

The eClinical Forum, a not-for-profit association comprised of representatives from pharmaceutical and allied industries, conducted the survey with support from TechTeam Global and other industry associations. Some key findings from the survey include:

- Substantial growth in overall use of EDC. Across the surveyed population, EDC is now used in 58 per cent of clinical trials versus 13 per cent in 2001. Ninety-five percent of respondents indicated that they have had experience with EDC during the last three years versus 52 per cent in 2001. And 27 per cent of respondents indicated that EDC is used in all of their current trials versus less than onepercent in 2001.

- Users generally satisfied with EDC, but opportunity for improvement. Sixty-seven percent of those surveyed are satisfied with EDC, however, results also showed a shift away from EDC as a positive factor in a site's decision to participate in a clinical trial. Nearly 50 per cent of respondents also perceived an increase in workload when using EDC, which is double the number reported in the 2001 survey.

- Duplication of data entry. The findings reveal that there is still extensive duplication in data input and that the use of paper case report forms (CRFs) alongside EDC has actually grown since 2001. Ninety percent of respondents indicated that more than 80 per cent of their clinical trial data is subject to duplicate entry.

- How to increase user satisfaction. Respondents identified speed of system response, cross-system standardisation, resources available for data entry and help desk support as among the most important opportunities for increasing user satisfaction with EDC.

"As health care and pharmaceutical technologies become more interdependent at the clinical research interface, the eClinical paradigm needs to be revisited in order to respond to advances and external influences," said Richard Perkins, president of the eClinical Forum. "Understanding investigational site personnel's experiences with today's clinical trial technologies, and their perspectives on future requirements, is critical to delivering improved eClinical solutions."

"TechTeam is committed to supporting the effective use of clinical trial technology in the life sciences industry and is thus pleased to help the eClinical Forum conduct this important study," said Chris Donohue, general manager of TechTeam Global's life sciences business unit. "Information from this study will be of significant value to all involved in the clinical trial domain and will help TechTeam improve its services in support of eClinical trials."

The survey remains open until 30th November. The final report will be released to eClinical Forum members in January and will be available to the public via the eClinical Forum Web site (www.eclinicalforum.org) and TechTeam Global Web site (www.techteam.com) in mid 2010.

Concept to completion

Meanwhile, a Central Institutional Review Board (CIRB) for cancer clinical trials that was created by the US National Cancer Institute (NCI) in 2001 has helped trials start more quickly (just over a month faster, on average) and thus expedite the time from concept to completion of crucial investigational research according to a new finding. This study of the CIRB was performed by scientists at the Veterans Affairs Palo Alto Health Care System (VAPAHCS) and Stanford University School of Medicine, Palo Alto, California with assistance from NCI.

Over the past 40 years, more than 1700 institutions in the USA have enrolled up to 20000 patients annually in phase III clinical trials coordinated by NCI and have used separate IRBs to monitor research involving patients. Federal regulations require that most NIH-funded clinical trials be monitored by an IRB.

To determine whether a new treatment is safe and more effective than current treatments using clinical trials is a lengthy process that can take up to 10 years and cost more than US$1billion, in some cases. Many researchers have complained that administrative requirements, including IRB oversight, are delaying the release of new treatments. One solution NCI proposed was to form a CIRB to conduct IRB review of large, multi-site oncology trials.

"Mounting a CIRB that is nationwide in scope has been challenging for NCI due to the complexity involved in assuring high-quality protection for study participants while attempting to speed the process," said Jeffrey Abrams, associate director of NCI's cancer therapy evaluation programme. "For all the volunteer reviewers and participating sites, this study provides objective confirmation that a centralised approach significantly improves the overall process for participants in multi-site trials."

The study assessed whether use of NCI's CIRB was associated with lower effort, time and cost in processing adult phase III oncology trials, which are the gold-standard of trials for validating whether a therapy becomes a new standard of care. Early phase trials (phase I and II) and paediatric trials were not included in the analysis due to the lower patient enrollment populations required.

Clinical trial sites that are not enrolled with the CIRB must have their local IRB conduct a full board review as they would with any research study. Sites enrolled with the CIRB have their local IRB conduct a facilitated review, which is a review category requiring only that the local IRB chairperson or designee signal acceptance of the CIRB's review.

To determine whether the CIRB was achieving the hoped-for efficiencies, researchers compared clinical trial review at sites affiliated with the NCI CIRB with the review at unaffiliated sites that used their local IRB. Oncology research staff and IRB staff were surveyed to understand differences in effort, timing and costs of clinical trial review. CIRB affiliation was associated with faster local review (about 34 days) and about six hours less research staff effort. Many clinical trials sponsors value faster and more predictable reviews and often pay commercial, fee-for-service, central IRBs to perform reviews.

Affiliation with NCI's CIRB was also associated with a savings of US$717 per initial review, of which about half was associated with time savings for research staff and the remainder was associated with savings for the IRB staff.

Overall, the programme resulted in a net cost of US $55 000 per month for NCI, but the CIRB could actually save costs if more sites were to use the CIRB. Moreover, this net cost estimate does not include the benefits of bringing new cancer therapeutics to market more quickly.

"Efforts are underway to expand enrollment in the CIRB and to encourage sites to use the CIRB to minimise administrative inefficiencies," said lead researcher Todd H Wagner, health economist, VAPAHCS and Stanford University School of Medicine. "And based on our research, increased efficiencies and net savings are likely."

The full study appears online in the 19th October 2009 issue of the Journal of Clinical Oncology

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