Sponsors/CROs – How to Sabotage Your Study Startup
Today’s article is a public service announcement to sponsors and CROs that feel their study startup processes are too fast and efficient. If this describes you, and you are ready to make bold changes, then be sure to adopt the practices below, and in no time your company will blend right in with a sizable percentage of the industry.
Don’t sync your site selection activities with your startup activities. This mainly applies when you use local IRB sites, which have well-established IRB submission dates each month. Say your deadline for choosing your sites is March 20. If there is a “must-have” site whose IRB meets March 25 and therefore needs to submit the protocol and consent by March 15, then be sure not to prioritize that site’s selection so that they are selected a few days before March 15 so they can put your study into the March review cycle. Better yet, don’t even ask for IRB meeting dates in your questionnaire, that keeps everything exciting and ensures some sites will lose a month.
Send documents to the wrong person. This will increase the odds that the documents will sit in an email inbox, on a desk, or in a mailroom for days (or more) before a human being (probably the busy physician) looks at them and sends them to the correct site manager.
Encourage your staff to discuss contracts, budgets, and consent forms by email ONLY. There’s no reason these often-complex discussions need to occur by phone, where both parties can have productive discussion about each others’ perspectives and reach resolution quickly. If mediocre is your goal, your staff should spend lots of time typing emails (or forwarding someone else’s email) and taking several weeks of back-and-forth to get to the crux of the issue that is in contention. This has the added benefit of there being lots of sites willing to play the same game.
Offer contract fallback language in sequential order, and require non-value-add documentation that your staff actually did so. This takes a lot more time than simply cutting to the chase and (verbally) offering what the site actually needs.
Don’t empower your staff to make decisions on the spot. Instead, make sure even the most minor changes require multiple levels of approval, creating a bottleneck that adds time to the process. This also saves you the trouble of adequately training your staff so that they can develop professionally.
Over-rely on past budgets to negotiate with sites. Sites appreciate your diligence in looking up what they agreed to be paid for a chest X-ray on a study you ran in 2008, without the background knowledge that that was a concession made because another area of the budget was more robust (or because it was a business decision so that the study wouldn’t be pulled). Operate under the assumption that a site budget is a collection of line items, without regard to business conditions or study complexity, and the ensuing negotiations will help you elongate your timelines. (Bonus Tip: Why should that work both ways? Cherry-pick the items that you want the site to agree to based on past budgets, but turn a deaf ear when sites make the same argument on other items).
We hope this helps you sabotage your startup process, if that is your goal. If for some reason you want to IMPROVE your startup timelines, then this article isn’t for you… or is it? And if you are a site, don’t fret - next week we will publish a similar list for sites that want to beef up their startup saboteur skills.
Adam Chasse MHA
Vice President, RxTi