September 12, 2017 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practicesand Chairman of MAGI. His passion is advancing the practice of clinical research by standardizing best practices in incremental steps, so every day is better than the last. He joins Clinical Informatics News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Terry Stubbs, President & CEO of ActivMed Practices & Research.

Terry, what do you think it’s about time for the clinical research enterprise to start doing?

More sites need to take advantage of industry standards. Sites of excellence understand that using internal and industry-standard procedures, training, forms, checklists, metrics, certifications, etc., not only save time, but also improve quality. Have you ever rented a car and then could not find the windshield wiper knob? Maybe you pushed the wrong button and made things worse. The same confusion happens all the time in clinical research because sites don’t have consistent procedures and standards. Sites need to work together to develop and improve standards, so working in research gets better for everyone.

Can you give us some examples?

Sure, why does everyone keep using different contract and budget templates? This year, our site has seen 45 different versions of contracts and budget templates. That can be very confusing and frustrating. What a waste of time! Norm, that’s why you started MAGI to create a standard CTA template. Why hasn’t the industry adopted it? If a sponsor or site doesn’t like the MAGI template, they can help improve it by giving MAGI feedback.

But it’s not entirely up to the sites to standardize contract and budget templates, is it?

No, but sites can press study sponsors and CROs to adopt at least parts of them. How hard can it be to agree on standard templates for Phase 4 studies? If there were only three choices of language for cross indemnification, that would save lots of negotiation time.

Are there standards that sites can use without the sponsor’s permission?

Yes, the Joint Task Force on Clinical Trial Competency has created a standard set of competencies that ACRP and others are merging into their training programs. The Metrics Champion Consortium has standards for metrics. The AVOCA Quality Consortium is developing standards for quality. ACRP, SoCRA, MAGI, PRIM&R, RAPS, SCR, SQA and other organizations maintain professional certification programs. AAHRPP accredits IRBs and HRP programs. MAGI has over 150 free standard forms, checklists and letters on its website. ACRES is developing an international accreditation program for sites; that’s where I’m spending my time.

Sounds great, so what’s holding us back?

Fear of change. It’s easier to just keep doing things the same way you did them yesterday. But the clinical research industry is changing fast, and the old ways that can create dirty data isn’t acceptable anymore. Money is time. Time is money. We can’t afford to waste either. One of the synergies sites see when they combine through mergers and acquisitions is standardization across those organizations. Site networks are growing because sponsors and CROs can expect consistency from their sites. CRO preferred site programs provide the same thing.

Well, Terry, you make a strong case. Sounds like we’ve been penny smart and pound foolish with our time and money for too long in this industry.

Norman M. Goldfarb is Managing Director of First Clinical Research LLC, a provider of clinical research best practices information services. Contact him at 1.650.465.0119 or ngoldfarb@firstclinical.com.