The cost of conducting clinical trials is high. And a poor record of patient recruitment and retention, along with the many incomplete or failed studies only add to the financial burden many sponsors carry.
Yet there are strategies to help reduce the costs of clinical trials. In this post, we explore what sponsors and research teams can do to improve operations for more cost-effective trials.
An Overview of the Cost of Clinical Research
Carrying out clinical trials from planning to completion poses many challenges and comes at a high price tag. Gen Li, founder and president clinical trials solution provider Phesi, reveals a few worrying statistics. In the past decade, 17.2 percent of phase ll trials and 12.2 percent of phase lll trials have been terminated before schedule. Globally, pharmaceutical R&D spending sits around $125-$160 billion a year, so those early terminations collectively cost around $20 billion a year.
Additionally, patient recruitment rates remain an issue. Data cited by Robert Bolduc, director of product management at the global data and technology company ERT, shows the number of countries conducting phase III trials doubled and investigative sites increased by 63 percent between 2005 and 2015, yet the mean number of patients declined by 18 percent.
Taking trials into patients’ homes is a useful means of improving recruitment and retention as well as lowering the cost of clinical trials. The obvious savings come from fewer trial sites and less reimbursement to patients and their caregivers for travel and accommodation. This is why direct-to-patient (DTP) services are gaining favor, explains Michael Sweeney, senior director at specialty logistics service provider World Courier.
The DTP approach can also boost recruitment and retention efforts. Sweeney says 50 percent of patients confirm they’re more likely to take part in clinical trials where there is a choice of home care. Retention rates also climb to 95 percent.
Clearly, sponsors are seeing the benefits of this approach, with 24 percent of clinical trials offering home-based care. Sweeney adds the caveat that this approach isn’t best for all trials. When ultra-sensitive or temperature-controlled therapies are involved, for example, patients may have inadequate storage at home to accommodate these requirements. For a DTP approach to work in this case, sponsors must ensure patients’ homes are supplied with suitable facilities.
Remote Trials Cut Costs
Investigator fees account for a significant portion of the overall trial costs. Indeed, Débora S. Araujo, founder and CEO of online educational platform ClinBiz, estimates the cost at between 40 and 60 percent of a total clinical trial budget. Reducing these, then, can lead to significant savings. An effective method of doing so is through remote monitoring, which Araujo says can drop trial costs by about 25-30 percent.
Additionally, remote monitoring can lower costs associated with patient travel and the amount of staff typically required to monitor on site.
Araujo warns that while there are savings to be had through remote trials, the provision of equipment in patients’ homes might ultimately present a higher price tag than traditional site-based studies that already have equipment on site. Remote trials will require patients to use wearables or other digital devices, as well as apps and potentially specialized equipment. Sponsors will need to ensure these costs do not spiral out of control and cancel out the cost savings of remote trials.
Adaptive Clinical Trials
Flexibility in trial operations can also lead to cost savings. Adaptive trials, with flexibility at their core, allow researchers to adapt protocol during the study based on gathered data. However, it’s important to note that these possible modifications are not infinite in number and the limited possibilities need to be planned for at the design stage, says Elliott Levy, SVP of global development at biotechnology company Amgen.
Some of the study areas that flexibility can be planned for include eliminating ineffective or unsafe doses, adapting the size of the trial, and adding more of the types of patients responding to the investigative drug.
A further benefit of this approach is that patients no longer have to participate in a trial in which the investigative treatment is or isn’t working. Adaptive trials ultimately lead to an improved cost optimization by increasing the likelihood of success while cutting spending, Levy explains.
Another advocate of the flexible approach is Jayesh Chaudhary, founder and CEO of contract research organization Vedic Lifesciences, who says adaptive trials speed up the process through improved responsiveness to data monitoring. To this end, Chaudhary notes that electronic data capture and electronic case report forms are essential to the flexible approach. The methods enable faster retrieval of data from multiple sites and sources, and can be accessed by all relevant research staff.
AI to Lower Costs
There are multiple stages in the clinical study journey that can impact overall costs. These stages include protocol design, patient recruitment and retention, and the gathering and sharing of data. Using technology — specifically AI — is a sensible means of making each stage more efficient and bringing costs down, explains Peter Meath, head of life sciences at J.P. Morgan Chase.
Better Protocol, Improved Recruitment, Faster Data Gathering and Sharing
It’s common practice for researchers to rely on data from previous studies to determine the best protocol for future research. AI does that but much faster and with keener insight than traditional methods. Meath says AI can also use the operational performance from previous trials to predict the likelihood of success or failure of a protocol design, patient response rates, and site performance.
AI will also improve researchers’ ability to determine patients’ eligibility by analyzing EHRs and comparing them with criteria from hundreds of trials. And one of the obvious boons of AI-enabled applications is data collection and analysis, in real-time. When used in clinical trials, this data will point to any commonalities of disease symptoms and prognoses.
Drug Development Optimization
There’s more. Artificial intelligence can optimize drug development, explain Arnaud Bernaert and Emmanuel Akpakwu at the World Economic Forum, Geneva. They point to a startup working with the University of Toronto that ran an algorithm on a supercomputer to simulate millions of potential medicines to test their effectiveness against Ebola. The results included far fewer physical tests and insight into which existing drugs could be repurposed.
A Lesson in Cost Forecasting Using Machine Learning
With trial delays costing sponsors more than $35,000 a day, accurate forecasting is essential to help manage and reduce the price of running a trial. A useful guide comes from Srini Anandakumar, senior director of clinical analytics innovation at advanced clinical data and analytics company Saama, who provides a forecasting plan as follows:
- Use machine learning to forecast all the predictor variables in every predictor variable group.
- Work out the measure item using the forecasted predictor and independent variables.
- Use the cost (negotiated or historical) to obtain the price of every cost line item, which can be used for more predictable budget forecasting.
- Once the trial is underway, replace predictor variables with actual values to calculate projected values for the remainder of the trial.
Save on the Supply Chain
Sponsors can save money by constantly reevaluating their supply chain and should avoid pursuing past supply chain procedures simply because they have used them before, writes Anthony Zuccarello, associate director of technical operations at biotechnology company Amicus Therapeutics. Every trial is unique and that goes for supply chain needs too.
Zuccarello gives the example of large international phase III or IV trials with many participating patients. Rather than using shipping routes from past trials, just because they have been used before, sponsors should make a decision based on first, whether to ship from a main depot to the clinical site or to open a local depot. The local depot decision will have to take into consideration the combined cost of shipping bulk from the main depot to a local depot, and then from the local depot to the trial site, plus maintenance costs of the local depot.
Each trial will lead to different calculations, but Zuccarello says this method can save sponsors hundreds of thousands of dollars.
Of course, there are many methods sponsors and researchers can follow to lower the costs of running clinical trials. More accurate forecasting and better data analysis are important parts of the process. But with expenses associated with patient recruitment and retention, and site investigators accounting for such a large proportion of the overall cost, adopting a patient-centric approach and remote-monitoring technology will lead to more cost-effective clinical trials.