In an ever-changing industry, as budgets tighten and the cost to finance a clinical trial rises through the roof, there are common challenges that resonate with all stakeholders involved.
Having spoken to over 40 industry experts at director level in the southeast region of the US, I was able to assemble their most relevant thoughts in their efforts to bring drugs to market. Regardless of the therapeutic field that trial sponsors operate in, the recurring issues that face the industry are: Improving patient enrollment and retention rates, utilizing populations in overseas markets, data management of clinical trials, and improving CRO selection.
Patient Enrollment and Retention Rates
Whether working on a niche indication, such as an orphan drug, or a highly competitive indication, such as diabetes, bringing on board the sufficient amount of patients to ensure success of one’s trial is a crucial concern. There’s a multitude of factors that can influence the rate in which patients enroll in a clinical trial. Considering the patient’s perspective during the design of a trial is something that can easily be overlooked. Trials should be made convenient in terms of minimizing the time they’re expected to take away from work and family, in order to ensure buy-in from the target population.
Retention is not to be neglected either; it must go hand-in-hand with enrollment. It’s said amongst many professionals that not enough is done to ensure the opinion of the patient is taken into account. Treating patients as throwaway customers endangers their commitment to a study and it’s vital that as the trial progresses, their involvement is made a top priority. This is key in ensuring enrollment numbers remain consistent.
Tapping into International Markets
Accessing international markets can be an effective method for finding sufficient numbers in your target population. Beyond just seeking patients for clinical trials, it’s beneficial to the industry in terms of supplying to a larger demographic and increasing their end user base. However, regulatory and cultural differences are two barriers that are arguably holding some companies back from venturing into new markets.
Considering how CROs can provide experience in conducting trials in accordance to foreign regulations is something many trial sponsors are looking for when selecting a partner. Additionally, having CROs with established partners in that region is advantageous for providing insight on how cultural differences can be conquered. This can ensure that patients and all involved parties are bought in and committed to the success of the trial.
Data Management of Clinical Trials
In this day and age, data is mostly entered, kept and managed electronically. Electronic Trial Master Files (eTMF) need to be collated and monitored correctly, if it isn’t, that doesn’t bode well for a successful application for approval. All parties involved in the trial need to ensure a uniform, coherent model is set in place to make sure all data is understandable between one another. Gaining insight into how an expert eTMF service provider can optimize your eTMF across multiple studies can ensure easier data management and in turn reduce time and resources when seeking approval.
Reviewing how to ensure eTMF audits are passed during inspection is essential in order to seek approval and reduce expenditure. Additional auditing can be a result of non-accessible data from the eTMF which results in the trial sponsor having to pay for further time spent conducting inspections for approval.
Data integrity can be lost or jeopardized, as data tends to travel between multiple sources. Ensuring that thorough quality checks are set in place between all parties when data is sent and received will eliminate data scrambling or loss of crucial information as it passes along the chain.
Improving CRO auditing and management
Ensuring the most compatible partner is selected for a trial is something all trial sponsors seek when outsourcing. However, it appears that achieving this goal is harder than it seems. Improvements to auditing potential partners during a bid can provide intelligence to improve decision-making as to whether the proposed deliverables are achievable and if the systems of both parties are compatible with one another, all whilst being cost-effective.
Effective management of the CRO comes down to building strong and long lasting communication, through a respected relationship between one another. Bringing on board a CRO as early into a study can ensure trials have an additional perspective and expertise to help it drive towards success. Setting in place metrics to quality check the performance of the outsourcing can be established early on in the contract, through penalties and rewards for underperforming or outstanding performance respectively. Approaching the outsourcing as a partnership which has benefits for commitment and performance can bolster the success of the study, and is a path that the industry should be aiming to adhere to.