Originally set-up as exception and plan B to reach geographically dispersed patient segments, the direct to patient clinical trial approach is losing its outsider status. Suddenly it finds itself in the midst of lively discussions both online and offline, praised as a remedy for all weaknesses of conventional clinical trials – direct to patient (DTP) distribution as the core-element to promote patient centricity. Some biotech-, logistics- and clinical research companies have dared to jump ahead and have integrated DTP services: According to a survey by Arena, Sonoco and Berlinger 24 % out of 230 respondents. One third of them consider DTP in the coming 12-18 months.
What are the gains of direct to patient clinical trials?
Direct to patient services in clinical trials hold some logical advantages for both the patients and the parties involved in conducting clinical studies – theoretically. Since this approach in clinical trials is rather new and still not wide-spread amongst trial set-ups, little data is available on whether direct to patient clinical research brings tangible benefits. It is still much learning by doing, but previous findings speak in favor of this new approach that some already see as the soon-to-be standard in clinical trials. Why is there so much enthusiasm about the direct to patient distribution model?
- Improvement in patient recruiting numbers: 85 % of clinical trials fail to recruit enough patients. Due to the greater convenience for patients that home-based trials bring along, this percentage could be reduced.
- Improvement of patient access: Due to the flexible approach of patient centered clinical trials patients can be recruited over much more extensive areas. Moreover, patient segments that so far have not been accessible by clinical studies due to their remote locations are opening up.
- Increase in patient retention: The average dropout-rate across all clinical trials is 30 %. Patients that dropped out stated that the site visits were stressful and did not fit well into their daily life. Home-based trials could provide more convenience for the patients.
- Reduce costs: According to Michael Sweeny, senior director of global service development at World Courier, medication waste can be reduced with the help of direct to patient trials. Patients do not need to take their medication from the site back home which always provides a threat to the medication´s integrity.
- Improvement of communication with patient: Putting the patient and his convenience in the focus of clinical trials, enforces the need to be in constant exchange with him and thus make him a key-player in planning and conducting clinical trials.
What pains come along with patient centric clinical trials?
That all sounds promising, yet there are substantial hurdles that need to be managed and new issues to think about. Since patient centered trials, as stated above, still undergo a continuous learning process it will need further discussion and more home-based clinical studies to learn from. Here are some issues that need to be considered:
- Uncertainty of the cold chain: According to the above named study of Arena, the respondents stated as the greatest risk of DTP services “the lack of control in the ‘last mile’ concerning temperature sensitive materials”.
- Complexity to follow study protocols: Depending on how comprehensive and complex study protocols are, it is a bigger challenge to perform all necessary trial protocols such as infusion, collecting blood and urine samples when patients are geographically dispersed. There are orphan drug studies that entail medication injection 3 times a day. A logistical challenge for everyone involved.
- Collaboration complexity: Clinical trials are complex in their set-up and even more so in their conduction as many parties are involved: clinical site, pharmacy, logistics provider, clinical research organization, sponsor etc. Home-based trials impose even higher requirements due to the decentralized patient-care approach. The flow of information between stakeholders and the patient needs to be clear and constant at all times. This is even more demanding for much of the study documentation is paper-based and thus is not available to all stakeholders at the same time. There are some interim solutions as to scan protocols via smartphone (e.g. CamScan) but so far there is not best-practice example.
- Increasing coaching need: Direct to patient clinical trials demand for both patients and trial nurses to be well-trained. The training must encompass the medication´s handling (when to take it, where to store it etc.), following the study protocol and dealing with logistics procedure – receiving medication and sending samples.
- Increasing need for patient support: Since in home clinical trials patients are not situated at the trial site surrounded by doctors and nurses, there need to be other ways to provide instant help and information. This holds true for health-related and for logistical issues as to receiving medication and sending samples. This is why Marken has launched its first 24/7 patient call center to streamline patient queries.
- Cost increase: Sending investigational medicinal products (IMPs) to the patients, sending biological samples from the patients to the laboratories – this all needs for special couriers trained in clinical studies and being specialists in cold chain management. System logistics providers such as DHL, TNT and their like are not considered an adequate option for DTP providers since medication has to be brought to the patient punctually when the nurse is there to administer medication. A time slot of two hours is just not precise enough. This makes home delivery cost-intensive. Yet there are first tentative tests with home cooling solutions that can significantly reduce the number of deliveries as the IMP is stored at the patient´s home.
The lists show that there some aspects that need thorough consideration. It also reveals, however, that there already are promising approaches which face and partly overcome the named hurdles. The direct to patient approach is putting the patient´s convenience and the patient´s say at the core of clinical trials. And this is a good direction we are taking.