April 23, 2019 | Norman Goldfarb is Editor of the Journal of Clinical Research Best Practices and 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 Research News with a monthly column highlighting new ideas for advancing clinical research. This month he speaks with Erika Stevens, Principal at Recherche Transformation Rapide.

Erika, what do you think it's about time we start doing?

Norm, it’s about time we consistently invest in proper planning before launching major initiatives like starting a new research program, implementing a technology, or developing a research office. Planning takes time, but failed projects take a lot more.

Nobody does proper planning now?

Everyone does it to some extent and some do it very well, but I can’t tell you how many times I’ve seen initiatives flounder because the people in charge hadn’t thought things through.

Can you give us some examples?

Sure, a research institute applied for and was awarded a multi-million-dollar grant, but was totally unprepared to do the work and lacked the processes to secure the necessary people, equipment and facilities. Technology projects are infamous for not thinking through how the new system will integrate with the old systems, or even getting buy-in from the people who will be using the new system. Implementation of new technology requires additional foresight for data migration, training and user acceptance testing (UAT). And, of course, many of the clinical research studies starting today will need significant protocol amendments before they even get to first-patient-first-visit.

Even with a good plan, things can still go wrong, right?

Certainly, that’s why a good plan addresses the risks and includes contingency plans. Things will take longer than planned and often cost more than estimates, so build those into your planning for risk failure mitigation and into contingency timelines.

When a plan fails, what are the most common causes?

The most common causes for failure are not gaining stakeholder buy-in (especially the end users) and not addressing risk mitigation and contingency planning up front.

How much time and effort should be invested in the plan?

Of course, it depends on the project, but, for example, with a research technology implementation, a range of 20-30% of the time and 10-20% of the budget does not seem unreasonable. And remember, it’s also possible to do too much planning.

How would I know whether my plan is adequate?

There’s no way to know for sure, but your chances are a lot better if the key stakeholders are engaged and buy into a shared vision, guiding principles, roles and responsibilities, operational processes, and realistic assessments of time, resources, risk and scope.

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.