Key Benefits
As a Survey by ePharmaSolutions indicates, 62% of the Clinical Sites feel that the ‘back and forth’ of regulatory documents and contracts is the major source for Study launch delay.
The Clinical Study-Portal tools will minimize any delays in the ‘back and forth’ process. Contract or Documents can be posted by the Sponsor on the Portal, while an email notification is sent out to respective sites. Sites can download contracts from the Portal. Signed contracts can either be faxed or scanned/mailed directly into the Portal. The assigned Communication person(s) at the Bio-Pharmaceutical company or CRO will receive an email notification and can save the document in the Portal environment.
The Study-Portal’s toolset plays a major role in improving enrollment rates of clinical trial patients.. First of all, having online access to the actual enrollment rates by both Sponsors/CRO’s and Sites/Investigator is of utmost importance. And is motivating in itself. Anecdotical is an example where our client used a weekly overview of ‘highest enrollers’, this proved to be the most effective measure in raising the enrollment rates.
And in some studies where finding the right patient is relevant, you can add a ‘public’ section to the Portal. This public section might contain information on the patient population required for a study.
Results based on online Health communities indicate that they allow patients to discuss details about their disease. These online groups result in a positive look towards the outcome of treatments and encourage patients to continue with the treatment protocol.
None of these online tools have been used in clinical trials (as far as we know). However, there is no reason to believe that the impact would be any different. In fact, as the average trial population is a more homegeneous ‘disease’ group, the motivation for patients to participate in online discussions might be higher.
It is clear that optimal communication with (and between) patients will result in fewer reasons for dropout, higher motivation and thus higher retention rates.
The Clinical Study-Portal’s web-based tools can also be helpful to track Patient’s adherence to the Study protocol and motivate them to keep to the prescription schedule. A simple example, if you are using the Study-Portal to collect online daily Quality of Life (QoL) ratings, you can track if patients are missing any daily rating and send them a reminder (by text message or email). You could include a simple question in the online survey; “Have you taken your medication today?”.
Sure, patients can say ‘Yes’ while not taking their drugs, but chances are that a larger group will use this reminder and take their study medication. And if there is a specific reason why they skipped taking their medication, you will be able to figure out directly (and react) and not at their next Site visit.
The only person who knows the amount of reduction in paper documentation is you. Because you know how much paper documentation is being sent to Clinical Sites. In the Study-Portal, all of your relevant Clinical Trial Documentation is available online, and so there is hardly any need to have any Documents in printed form.
In most clinical studies the cost for sending packages by courier largely exceed the license fee of the Study-Portal.
In fact, this should be one of your key drives to start working with the Clinical Study-Portal. Most clinical trials are facing the challenge of working together with different groups, which are usually widely dispersed over timezones and countries/continents. The Study Portal tools will greatly help you to overcome these barriers. One of the major advantages is that by using the Clinical Study-Portal for communication, you don’t have to repeat the same message over and over again. If a problem has been resolved through the Forum (or by email and later posted on the Forum), any other person having a similar problem, can be referred to the Forum.
And as has been pointed out in several surveys, the number#1 hit for Site Investigators is that they want to be able to communicate with their peers. With the Study-Portal, they not only know who their peers are, but they have the ability to directly communicate with them.
Any of the previously listed Benefits of using the Study-Portal will result in a more efficient spending of your Study Budget.
- When you reduce the timeframe for Site Initialization through efficient document and knowledge exchange, your Trial will be finished earlier and your time-to-market will be less.
- Improved Enrollment rates will result in a reduced enrollment period and thus your study will be finished sooner.
- When fewer Subjects drop-out, less money is going down the drain.
- Any effect of study-drugs will be more visible when more Patients adhere to the Study Protocol.
- The savings in courier costs usually outweigh the Study-Portal license costs.
- Although difficult to express the value of enhanced communication, at least the savings in handling-costs of Study issues can be calculated.
When you compare all these cost saving with the actual license cost of the Study-Portal (see our License fee overview), it will be clear that your ROI will indeed start counting from day 1.