Fast and successful clinical trials are the holy grail of drug development: the ultimate but very difficult goal to achieve.
The statistics surrounding drug development, especially clinical trials, are sobering.One learn Research conducted by the Institute for Safe Medication Practices (ISMP) found that the median cost of key Phase III trials was US$48 million. In addition to the overall cost, the study also looked at cost drivers and found that the largest single cost driver was the number of patients required for the study (average estimated cost per patient: $41,413), followed by the number of visits to the trial clinic (estimated per Median cost of visits to the research clinic for one patient: $3,685). Their model shows that the cost of testing increases exponentially with these two variables.
To make trial recruitment more difficult, more than 60% of patients did not meet the eligibility criteria for any given study, and a significant percentage drop in participation resulted in 80% of trials being delayed, and 20% of trials being delayed for six months or more .
No wonder drug developers are looking for ways to simplify clinical trials and improve the factors they can control.
Let us take a closer look at the controllable factors.
Cooperate with suitable locations and lead investigators
The choice of site and PI is very important, because they will seriously affect the speed and success rate of patient enrollment. The site should have relevant patient groups and experienced PIs, who will not only see these patients, but also have a referral network that they can use.Fast registration can avoid delays-another costly factor-and Underpowered research, Its statistical power is limited, only allowing the sponsor to draw limited or no conclusions, and worst of all, it may expose participants to risks without the need to provide meaningful knowledge.
Experiment with different patient groups
Increasing the diversity of patient cohorts, such as including more women, ethnic and ethnic minorities, elderly patients, and other underrepresented groups, is not only an industry commitment, but also FDA guidelines as of November 2020. Although FDA guidance documents are not legally binding, they must be taken seriously because, as expected, FDA tends to follow them. More and more trial participants rely on detailed knowledge of the communities in which underserved communities with high incidence rates are located, so that they can choose locations accordingly. It is important to identify the ability of healthcare providers to work in these underserved communities, understand their concerns, and earn their trust. If they provide convincing arguments, these healthcare providers can successfully recruit underserved patient groups, and if they provide convincing arguments, how they will benefit patients.
Understand the competitive landscape and trends
Understanding the environment in which the experiment takes place is critical to success. For questions such as “Are there similar or competitive trials going on and where?”, “Does our preferred PI participate?”, “What successful and failed trials have been conducted in the past?”, “If they fail, why? “Wait for the answer to the question. It can help simplify the design and planning of clinical trials, avoid delays, and hone the relevant patient population, location and PI.
Comprehensive and comprehensive data promotion research plan
What all these controllable factors have in common is that the more data trial sponsors have, the more proactive they are to solve these problems. Related data streams include:
- The latest information on clinical trials,
- Claims and referral data,
- Expected PI details, such as clinical trial experience, current trials in which they participate, referral network, number and impact of publications, and their payment history, which can improve the sign of interaction with competitors.
- Comprehensive site information, such as research impact, comparison with similar institutions, scale, referral network and the patient groups they serve.
However, isolated data streams cannot solve the problem. Different data streams need to be integrated and merged with the company’s long-term collection of proprietary information to create a single source of truth that can be used by stakeholders across the organization.
Decentralized testing addresses key cost drivers
Since the number of visits per patient is one of the main cost drivers of clinical research, reducing this number can significantly reduce trial costs.The cost of telemedicine access is approximately half The use of wearable devices for clinic visits and health monitoring, and at the same time incurs the cost of electronic equipment, saves personnel time, and is enough to make up for these costs.
More importantly, frequent medical visits are often a deterrent for patients, especially those who live far away, are seriously ill, or cannot take time off due to financial reasons. Therefore, reducing the burden of trial participation by providing telemedicine, mobile medical or in-person visits in closer and decentralized facilities will help to register and retain faster and more successfully, thereby reducing clinical trial costs.
Data and decentralization-two key factors for the success of clinical trials
Clinical trials are always time-consuming and expensive, because drugs and medical devices need to prove their effectiveness and safety in a large number of patients over a long period of time. However, using all available data sources to optimize clinical trial design and planning, and adopting new trial formats, such as decentralized trials, telemedicine, and mobile health applications, can bring us closer to the Holy Grail: conduct fast, successful clinical trials— -Even reduce costs.
