The critical elements of study startup
The study startup phase has the lowest performance scores and the greatest variation in performance than any other stage of clinical trials.
To accommodate these deficiencies, the focus of sponsor and CRO efforts toward study startup has gained traction in the last five years. This is evident in the recent surge of companies geared toward streamlining startup activities and also the implementation of large startup groups at CROs dedicated only to this function. Research sites now are expected to complete all work and activities in a much shorter timeframe than what was once required. A look into the different aspects of this issue should provide insight into potential areas of consideration for sites.
The shift in expectations begins with feasibility. Long gone are the days of taking two to three weeks to complete a feasibility questionnaire. Often, if you have not returned a questionnaire within three to four days you may have missed your opportunity to participate in that particular trial. CROs are constantly pushing for feasibility to be completed in just one or two days. As research sites, we should be concerned with whether or not we really were given the adequate time necessary to provide a true picture of what we are capable of accomplishing according to the specific protocol set before us. In order to meet fast turnaround expectations, feasibility questionnaires often are completed hastily, doing an injustice to sites and possibly setting up the enrollment of the study for failure. We would be better off to include a day to rethink our site’s capabilities based on the protocol and enrollment constraints in an effort to ensure an accurate account is reported therein.
Another area to consider is time lost if budget expectations are not comparable for the site and CRO. Frequently sites do not receive the budget until after a pre-study visit is performed and sometimes after time and energy are expended on regulatory and startup documents. Disclosing the budget up front saves research sites and sponsors valuable time in the end. If the expectations are not similar for the requirements of both parties it would be beneficial to have this conversation sooner rather than later. Sites should always strive to obtain this information early on in the startup process.
The contract negotiation process can be extensive and great thought and consideration should take place in order to improve it. Unfortunately, we cannot control the lengthy legal review process required by most sponsors. Typically their contracts groups are small, but responsible for reviewing a large number of contracts for all studies in startup. To avoid any potential delays, I encourage sites to carefully evaluate what contract revisions are truly necessary before returning the contract to a sponsor. I would advise the same precaution regarding additional and potentially unnecessary budget item requests as these also can contribute to delays in the review process.
Once a budget and contract are agreed upon, the onus is on the site to perform all other startup activities in a short timeframe. When possible, it is advantageous to begin working on regulatory and IRB submission documents simultaneously during contract and budget negotiations. For studies with competitive enrollment, this gives your site the edge to become one of the first to open and thus meet your enrollment goals.
With recent emergence of companies like goBalto, HealthCarePoint and DrugDev, this process can be improved upon even more. goBalto uses their technology to streamline and track the progress of study startup while avoiding potential bottlenecks. HealthCarePoint serves as a central document repository allowing a network of sponsors, CROs and sites to share real-time information and avoid document redundancy. DrugDev provides an opportunity for sites to register in its investigator database, and one of their goals is to eliminate the administrative burden during startup.
Although improvements have been made in recent years, certain aspects of study startup still require our attention. Sponsors, CROs and research sites all play a vital part in this process and advances cannot take place without cooperation from all parties. In an extremely fast-paced industry, just taking the time to evaluate these basic elements of startup can have a huge impact on the overall success of your site and the study itself.
Jeffrey Adelglass, M.D., F.A.C.S. is founder, owner and president of Research Across America (RAA), a U.S.-based, privately owned, multi-site, multi-discipline clinical research organization. RAA owns multiple research sites across the U.S. and has performed over 1,800 clinical trials in multiple disease areas. Email comments and questions to firstname.lastname@example.org.
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