Outsourcing is advantageous for medical device companies. Not only does it save resources and reduce operating costs but it also gives an opportunity to focus on core activities. However, there are a number of challenges that arise when outsourcing part or all of a medical device trial. My research has identified four key themes:
Clinical Trial Outsourcing concerns for Med Device Start-ups
For small medical device start-ups looking to outsource, there seems to be a multitude of trials and tribulations faced at every turn. Oftentimes, start-ups work with sites and CROs who don’t have sufficient experience working with smaller companies, leading to budgetary issues and timeline concerns. In these cases, vendors are not used to having economic constraints, giving rise to enrolment and oversight obstacles.
“The problem of outsourcing everything includes finding people who are competent and happy to work with start-ups,” one clinical trial professional said. “They must understand we work with smaller budgets and strict timelines.”
For virtual companies it is often a race against time to finish the trial before running out of money, a predominant issue CROs must recognize. While the sponsor’s priority is to develop a drug that’s safe and effective, operating within a tight budget is vital for small companies, in order to show investors they are making good use of their money.
”That’s one of the biggest challenges – striking the balance between conducting a study that’s good enough to get regulatory approval while managing a lack of funds,” said the CEO of a small medical device company. “With budget shortages, you can’t always afford professionals that are experienced in running trials.”
This is where vendor oversight and monitoring comes into play, especially for the smaller companies that cannot afford protocol deviations or trial delays. It’s important to bring on board a site coordinator that works for the sponsor company, as they’ll be better placed to make decisions on trial budgets. The more the site coordinator knows the company, the better the trial will run for the sponsor.
Tackling Site Selection and Management in Medical Device Trials
As with any clinical trial, site selection can pose challenges for sponsor companies. There are a number of factors, sponsors should consider during what is a critical phase. For one, the site must have experience working within the relevant therapeutic area, and they must prove they can recruit subjects successfully.
Often the best sites can be found through word of mouth. Some sites are more collaborative than others, which mean they are willing to make changes, willing to adjust, and willing to accommodate the sponsor’s wishes.
Another enduring problem that all sponsors face is assembling the right clinical team to conduct the trial. This is a critical stage that can often bear huge implications if sponsors don’t get this right.
When a CRO’s unable to enroll enough patients or the wrong patient population, they may not always enter the data correctly. In such cases, the FDA will come down hard on the sponsor as essentially they are responsible for the outcome of the trial. The knock-on effect of ineffective sites can often result in unusable data.
“There are no bad dogs, just bad owners,” said the Director of Clinical Operations for a mid-sized company. “Hence, we need to manage the site correctly using good site coordinators and we must develop good relationships with them. This enables greater visibility setting the platform for better trial outcomes.”
Patient Enrolment, Escalation and Compliance
One of the biggest stumbling blocks in clinical trials is the recruitment of patients. While sponsors will have in place a strategy to enroll patients, when targets aren’t being met, there needs to be a plan of escalation to ensure the study gets back on track to meet its goals.
The one thing that is within the sponsor’s control is patient enrolment; the faster they’re able to recruit, the better. Nevertheless, keep in mind patients must fit the inclusion criteria. Therefore, an enrolment plan and how to manage referral pathways should be a priority for sites during the start-up/design phase of the study.
Another factor that can often determine the success or failure of a trial is patient compliance. If patients are given a device and asked to report on it three times a day, for example, it is hard to remain fully compliant due to daily activities. It’s especially hard for patients with social and health burdens.
”As sponsors, we often want to learn from providers about how to increase patient compliance on a daily basis,” said one clinical professional. “By increasing patient compliance, patients are encouraged to fully participate in a trial.”
At the start of a trial, sponsor companies will often want to give predictive numbers, which involves looking at their data requirements and assessing whether patients will realistically comply. The solution for this is to either enhance site training or carry out closer monitoring. Low patient compliance can have a huge knock-on effect on the trial. For example, the data quality will decrease and if this drops below the tolerance level the trial results may have to be dismissed.
“Patient actions are defined on paper, therefore, we need them to be as compliant as possible. Very few are 100 percent compliant. While we are learning a lot, our experience is limited. We want to hear from providers who are doing hundreds of studies,” the professional said.
So how can sponsors overcome the challenges posed by data validity? Sponsors can prompt the site to contact patients if low compliance is detected. Sites must be trained to the highest possible standard to recognize and mitigate compliance issues. However, for sponsors conducting trials taking place globally, the big challenge is not being able to contact patients directly due to the difference in time zones. In these instances, it’s important to have a point of contact who can liaise directly with the sites.
Having in place an effective compliance strategy can have significant bearings on patient retention. Retaining patients throughout the course of a study remains a significant challenge, especially when follow-ups after the trial are needed. The implications of a high dropout rate can impact the validity of the data collected as well as its integrity. To solve this, sponsors must rely on their sites and coordinators. Frequent communication and checkups are vital.
Effective Remote Monitoring in International Clinical Trials
When it comes to clinical quality, remote monitoring can often prove effective. However, sponsors and regulators must appreciate that there is no “one size fits all” when it comes to monitoring plans. Recent efforts by the FDA and the EMA are encouraging sponsors to explore more effective monitoring strategies, promoting a more risk-based approach for the monitoring of clinical trials.
A variety of approaches can be used by sponsors to ensure monitoring obligations are fulfilled. Traditionally, this has involved on-site visits where monitors are required to check a high percentage of the data entered on the case report forms against source, to ensure that the protocol is deployed correctly, and adverse events are reported. The size, complexity and number of clinical trials mean that complete on-site monitoring is becoming an expensive and inefficient process.
However, effective monitoring is critical for the protection of subjects and the integrity of the data produced, meaning that on-site monitoring is still required by regulation for critical study parameters. To use remote monitoring effectively, a risk assessment must be performed and included in the monitoring plan prior to the start of any clinical program and adapted as the program evolves.