Clinical trials have become increasing costly ventures, adding to the overall cost of developing a drug and, ultimately, the price that patients pay for drugs. A 2016 estimate by the Tufts Center for the Study of Drug Development, for example, pegged average clinical trial costs across all three phases of development at roughly $340 million in out-of-pocket expenses.
Big pharmas and small biotechs alike are looking for innovative ways to improve trial outcomes and, in turn, lower trial costs — this means increasing the efficiency in which they recruit patients, monitoring more closely how drugs are supplied and being more flexible about trial design. Here’s a look at some of the tools that are optimizing clinical trials today:
1. Patient centricity
Patient centricity has definitely been one of the major buzz words within the industry over the last few years. This hot topic is now part of clinical trials as well.
Patients are using their internet know-how and drawing on the increasing influence of advocacy groups to get more involved in all aspects of their clinical trials. In parallel, patients are also forming more support groups to discuss their disease and available treatments and these support groups often continue past the trial.
Insights from these patients and groups can benefit pharma, allowing them to adjust patient protocols to better suit real-world conditions and improve patient quality-of-life.
2. Tapping into technology
Mobile devices are not just for Instagram and text messaging anymore. As consumers become increasingly comfortable with using their mobile phones for everything from internet banking to shopping online, they are also becoming increasingly comfortable with sharing health information over their mobile devices.
Pharma and biotechs are using mobile messaging to increase patient recruitment ahead of trials and then keep patients on track during clinical trials. Companies like mProve Health have shown that using mobile platforms increases patient recruitment by 30% and can reduce the cost of trials. Mobile apps can also remind patients about appointments, when to take drugs and even provide instructions.
3. Data you can wear
Expanding on the idea of using technology in clinical trials, there is a movement to have patients bring their own devices. While patients may be more comfortable with their own devices, there are still concerns about how secure the data may be and what happens if a patient loses their device.
Clinicians and pharmas are also tapping into the use of wearables to get better patient data since the device can be with patients at all times.
In fact, last year Sanofi and partners completed a fully-remote clinical trial in Europe in patients with diabetes. The VERKKO trial tested a 3G-enabled wireless blood glucose monitor. Sanofi participated to see if it could be an efficient form of conducting a clinical trial and if it brought value to patients.
AstraZeneca recently showed that building flexibility into your clinical trial design can be a smart move in a changing landscape. The British pharma responded nimbly to market changes from competitors when Bristol-Myers Squibb’s Opdivo (nivolumba) failed in non-small cell lung cancer last year.
The company was able to adjust the endpoints and increase the number of patients in its Phase 3 trial for its immunotherapy. While the results will be delayed, AstraZeneca believes the new adjustments to the clinical trial will give durvalumab the best chance of succeeding, either as a combination or a monotherapy.
5. Automated site supplies
Some pharma and biotech companies have begun to use computer-controlled supply systems to automate drug dispensing and manage site inventories. The practice is becoming more common because it allows for less waste within the supply chain and gives companies a tighter handle on the amount of drug used.