Drug delivery
The rise of smart self- injection devices
Haselmeier, the drug delivery division of medmix, introduces the innovative D-Flex Logbook, which complements patients’ self-injection from clinical testing to commercial launch. Frank Leipold, vice president of product and portfolio management at Haselmeier, explains why the D-Flex Logbook is key to more transparency in clinical trials and how it adds tangible value during clinical testing of new drugs.
T
he success of clinical trials with self- injection devices relies on patient compliance. While many patients comply with their therapy, others might not or only in part. “Until now, there are only limited possibilities to check the extend of patients’ real adherence to the prescribed therapy. Clinicians mostly rely on patients’ feedback,” Frank says. And that is one of the reasons why wearables and connected devices are increasingly finding their way into clinical trials. Connected devices enable data to be collected directly and automatically at the point of care, reducing the need for costly patient visits respectively cumbersome manual data acquisition. In order to make clinical studies with self-injection devices more transparent, Haselmeier developed the D-Flex Ecosystem in 2020. This real-time solution enables stakeholders, such as clinical research organisations, to quickly utilise real world evidence to impact patient behaviour during an ongoing trial. However, this kind of ecosystem usually depends on a patients’ access to a mobile phone, either their own or an additional one provided by the investigator. Additional devices increase operational and regulatory efforts and raise the overall cost of clinical testing. This is why the company has developed the D-Flex Logbook, which collects injection data at the point of care without the need for a patient mobile app.
Based on a proven technology Haselmeier’s systems are based on a proven technology, which was successfully used in a clinical trial with 75 patients in 2018. The learnings from that trial translated into the new and improved D-Flex Logbook. It consists of the disposable D-Flex injection pen and
The connected cap can store up to 1,000 injection events.
the connected cap, which replaces the standard cap of the pen. Patients remove the connected cap from the injection pen, dial a dose, self-inject and put the cap back on the pen – exactly how they would use a pen and a standard protective cap. Once the patient returns the cap onto the pen, the connected cap automatically identifies the administered dose, the current temperature and time and stores this injection event in its internal memory. The cap can store up to 1,000 injection events.
Tangible value for pharma companies
These events can then be retrieved by study nurses or clinicians at each patients’ site visit to identify and address issues with patients during the ongoing trial. For example, there could be double dosing events when patients are not sure if they have already administered the drug that day. Or there could be repetitive patterns, indicating scheduling conflicts on certain days, so that patients cannot administer the drug at the right
World Pharmaceutical Frontiers /
www.worldpharmaceuticals.net
time. As a last example, patients could be storing the pen at the wrong temperature, for example by leaving it in a car on a sunny day and increasing temperatures to a point where the drug loses its efficacy. This additional information supports the interaction with patients during the ongoing trial and should help to improve patient behaviour. The most important benefit of both systems, the D-Flex Logbook and the D-Flex Ecosystem is that they allow evaluation of the legitimacy of each patients’ outcome data. Without such a system, patient data from non-adherent patients or incorrectly stored injection pens would dilute the efficacy level of the outcome data of adherent patients. In summary, the D-Flex Logbook provides paper-free numerical evidence for each patient, allowing study sponsors to evaluate adverse events and to exclude certain patients´ data based on real-world evidence, which should positively impact clinical outcomes of newly tested drugs. ●
www.haselmeier.com 17
Page 1 |
Page 2 |
Page 3 |
Page 4 |
Page 5 |
Page 6 |
Page 7 |
Page 8 |
Page 9 |
Page 10 |
Page 11 |
Page 12 |
Page 13 |
Page 14 |
Page 15 |
Page 16 |
Page 17 |
Page 18 |
Page 19 |
Page 20 |
Page 21 |
Page 22 |
Page 23 |
Page 24 |
Page 25 |
Page 26 |
Page 27 |
Page 28 |
Page 29 |
Page 30 |
Page 31 |
Page 32 |
Page 33 |
Page 34 |
Page 35 |
Page 36 |
Page 37 |
Page 38 |
Page 39 |
Page 40 |
Page 41 |
Page 42 |
Page 43 |
Page 44 |
Page 45 |
Page 46 |
Page 47 |
Page 48 |
Page 49 |
Page 50 |
Page 51 |
Page 52 |
Page 53
