Pharmaceutical executives are constantly looking for ways to cut down clinical development costs; listen to any pharma company’s earnings call for proof. And yet there are clinical development costs right in front of them that can be avoided.
Protocol amendments occur when a pharma company must revise the clinical study it is conducting. These amendments cost time and money, and it turns out that many of them are preventable.
According to a recent study of clinical trial protocols by the Tufts Center for the Study of Drug Development, 23% of protocol amendments are “completely avoidable.” These completely avoidable amendments are caused by protocol design flaws and inconsistencies and errors in the protocols.
Pharmaceutical companies and clinical research organizations (CROs) manage design flaws by considering sound clinical rationale relative to objective industry benchmarks. By assessing the alignment of protocol activities against objectives and endpoints, trial sponsors can ensure that there are no unassociated activities that could significantly increase protocol complexity and patient burden.
Non-essential activities drive up the cost of clinical trials unnecessarily and the trial budget increases exponentially as the trial undergoes the extended life cycles of these avoidable amendments.
The Tufts study notes that 22% of protocol amendments are “somewhat avoidable.” These types of amendments typically result from difficulties sponsors face in meeting recruitment timelines or the lack of incorporation of investigator feedback during the protocol and site feasibility processes.
In a robust and comprehensive protocol feasibility process, the sponsor will solicit feedback from therapeutic area thought leaders and key opinion leaders in order to optimize the activities of a protocol. The aim is to include only those procedures that are necessary to derive the clinical outcomes needed for the statistical and clinical analysis of a trial.
Once the protocol is optimized around essential activities, the site feasibility process should allow prospective investigator sites to provide feedback on the study’s viability, according to the protocol details, at that facility and within the proposed timeframe. If an investigator site expresses the opinion that the protocol activities impose significant burden to the site or patient, this feedback should be taken into consideration before the initial protocol is finalized and sites initiated.
Very often the site feasibility process occurs too late in the protocol development lifecycle, and the study team initiates the trial with the foregone conclusion that an amendment is inevitable.
A well-designed protocol that requires the least invasive and the fewest number of procedures to support the trial’s objectives offers the best chance of minimizing the need for subsequent amendments.
Reducing the number of procedures may also reduce the burden on the patient. It is an ethical obligation to consider the patient burden when designing a clinical trial protocol. Doing so also has a positive impact on patient recruitment and retention rates.
Ultimately, a well-designed trial with limited amendments reduces the burden on both sponsors and patients and creates the outcome of successful trial execution and regulatory filing.
This article originally appeared on our Forbes channel.