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Transforming Clinical Trials

By Study NeedBy Study Role

July 29, 2020

Why Are We Still Throwing Protocols over the Wall to Site Staff?

Findings in the Tufts CSDD-Teckro study are important for the industry to discuss

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      Brendan Buckley

      Dr. Brendan Buckley

      Chief Medical Officer


    There was a time when telephone companies distributed fat paper directories each year. White pages for personal numbers, yellow pages for business listings. Typically, they were delivered during the day to our homes, when most of us were at work. This meant they were left in mailboxes, on doorsteps and in hallways. Generally, mine was thrown over my garden wall and then sat for hours withstanding the weather of the day.

    I imagine that the phone company presumed that I used the directory, but they had no way of knowing for sure. And they probably also expected that I used the most current directory, but they couldn’t know that actually I often used an older one. Consider the millions of trees used to publish a new directory each year, when in reality the producer didn’t know when, or even if, it was used.

    With smartphones, printed phone directories are all but extinct.

    Clinical Trial Sites Are Stuck in that Past

    It is disappointing – but not surprising – to see the results of the industry research we conducted in collaboration with Tufts Center for the Study of Drug Development (CSDD). Paper is still heavily used at sites, along with static PDFs accessed from desktop computers.

    You could say that essential study documents like protocols are still “thrown over the wall” to sites, just like my telephone directory would have been decades ago. Who, when and why they are accessed is largely unknown, except through a survey like this.

    Yet each year, the most frequent inspection of observations from the FDA are related to investigations that were not conducted according to the protocol. What can we expect if retrieval of information from current documents is not so easy for sites?

    Archaic means of information retrieval just don’t cut it in our everyday lives, certainly not when we can reach for a world of knowledge 24/7 with the phone in our pocket. So, how can we justify not applying this same approach to the information in clinical trials?

    Simplifying Jobs to be Done for Research Staff

    To be effective, technology must focus on helping clinical trial sites to be more productive through simplifying, reducing friction and making things easier. I know this sounds obvious – design clinical trial software from the perspective of research sites. But I would venture to say that a lot of the technology out there has been designed by people who have never visited a research site and don’t really understand in practical reality what sites really need.

    We’ve seen it with most software over the years. Technology handed down from on high that doesn’t suit the jobs done by site staff typically has low adoption rates, it often adds complexity and increases workloads. Sites will only truly embrace technology because they love it. They will only love it if it makes their job easier and helps them do their job better.

    You might argue that many study portals can be accessed on smartphones. Sure, but in reality, small screens and PDFs are enemies. It’s against our very digital nature to scroll through a document when we are so conditioned to ask a question and get an answer. Besides, when was the last time – if ever – you ran a search in a PDF on your smartphone? I’m not even sure how to do it.

    The reality is that sponsors and CROs continue to operate in an apparent “safe zone” – one biased towards risk mitigation rather than task optimization. Paper and online portals appear superficially “safe” from an audit perspective. And we’ve always done it this way. But at what cost?

    If the paper protocol is not stored where participants are seen, as reported in the Tufts CSDD study results, then what is the cost of not having the right answer right there, to answer a question on eligibility? As an investigator, how good is it to have a paper protocol in my office or an online portal when a patient phones me at 8pm while I’m at a ball game to ask me how to handle a possible toxicity?

    Giving a Voice to Research Staff

    Sites need to be seen more as crucial stakeholders rather than servants of trials. It’s time that we shine a light on those technology solutions that work well for sponsors and CROs but complicate life in the field. Online portals are fine in theory; a secure repository for documents. Perfect – if you don’t actually need to access the documents in a hurry.

    And when it comes to communicating changes, then email is the obvious safe choice. We see from the study results that only a few respondents find out about protocol amendments from updates pushed out in the sponsor/CRO portal. This compares with the majority who say they receive updates via email. But we know all about the tsunami of emails we get daily, and in spite of best intentions how many emails are put in the “get to you later” category.

    A lot of time and effort is spent in protocol design and amendment. Protocols are getting steadily more complicated. Why then is access to the protocol so outdated and inconvenient? It really makes no sense. We need to stop thinking that throwing protocols over the wall to sites is good enough. It is not.

    We hope the results of this Tufts CSDD-Teckro research ignite a conversation about the information needs of site staff – many of whom are trying to conduct clinical research in addition to standard clinical care. And sadly, because it is so difficult, half will never do another trial after their first one.