Patient Centricity in Clinical Trials

Managing the risks that come along with data return


There is no doubt that returning individual data creates potential risks for sponsors.

Irresponsible communication to patients can cause huge damage: mistiming the return of data can jeopardize a trial and delivering medical data in the wrong context can become an issue as well.

Proactive management helps to overcome these barriers with the following approaches:

1. Right timing of lay summary return: providing information to all patients, and offering those who were in the control group an opportunity to participate in another trial

2. Ensuring that any communication is written in lay language and reflects the clinical trial accurately, in consultation with the investigator when necessary

3. Include investigators in determining how and when data is delivered

Sponsors already use our Be the Partner Platform to give patient data back. If you are interested in how it works, please do not hesitate to contact us.

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Opportunities in European transparency regulation EU536/2015 ANNEX V

Last month we talked about how Be the Partner gives sponsors the opportunity to become compliant with the European transparency regulation EU536/2015 ANNEX V. Today, we’d like to address the new opportunities that come with this change.

Most trials run in EU and Non-EU countries at the same time, but only EU trial patients will have the right to receive lay summaries. Posting a lay summary online and directing all trial patients to that site while only EU patients have access or, even worse, only directing EU patients there can be misleading and alerting for Non-EU participants.

Therefore sponsors need a user-friendly, responsible, and proactive way to distribute lay summaries via a central platform like Be the Partner. Furthermore, sharing lay summaries will boost the Sponsor’s image due to the fact that transparency and the outcome of a study are the core interests of patients.

Summing up, if communication between patients and sponsors reflects the true science of the data in a transparent way, sponsors gain trust and create an emotional bond.

 

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Ethical obligations of patient engagement

 

While medical drug development increases steadily, ethical obligations within clinical trials play a greater role. Many patient groups seek to give trial participants a voice and ensure that pharmaceutical companies pay attention to their responsibility towards their patients.

Be the Partner enables sponsors to fulfill their ethical obligations easily by enabling them to inform patients about the drug as soon as the product comes to the market.

Patients  who did not respond well to the investigational drug during the trial are protected from setbacks, and will clearly benefit from this information. But patients who did respond well will also have the opportunity to inform their doctor,  and potentially take the drug again.

In a nutshell: direct patient engagement and communication derives value for both parties and makes clinical trials more transparent.

 

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What happened at DPharm US 2017

 

Last week we had great conversations at DPharm US in Boston. We’d like to share the two aspects that stood out the most at the conference:

  1. Be the Partner enables pharma to be connected to their trial patients during and after the trial. Our long-term connectivity makes sponsor-patient relationship management a standard in clinical trials and gives pharma the opportunity to be constantly in touch with their patients. At the same time the sponsor has full control of all content that is being sent to their patients.
  1. We enable pharma to set up access once to provide data return, lay summaries or other information to patients during and after the study. This enables sponsors to become compliant with regulations such as EU 536/2014-Annex V.

We appreciate the positive feedback on our platform. Looking forward to seeing you at DPharm next year!

 

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How pharmaceutical companies can become compliant with EU536/2015 Annex V

 

All clinical trials performed in the EU are required to be conducted in accordance with the new EU regulation EU536/2015. This new regulation aims to create a more safe and favorable environment for patients within trials. One goal of this regulation is to increase transparency during and after trials. An example of this is Annex V, the requirement to provide lay summaries for all patients within a limited period of time. This EU transparency directive will be a mandatory regulation by Oct 2018.

With Be the Partner, pharmaceutical companies and their trial teams become seamlessly compliant with this new regulation. Thomas Klein, CEO of Be the Partner will present our #beyondtherial approach and how we easily integrate the new regulation at DPharm US this Friday in Boston, starting at 11.50am. You can also meet us there at booth #50.

See you soon!

 

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Join us at Disrupting Clinical Trials Sept. 7th -8th + Exclusive 25% Discount

We are looking forward to seeing you at this years DPharm Conference in Boston at Marriott Copley Place. Meet us at booth #50 to get our new Whitepaper and hear more about our #BeyondTheTrial approach.

 

 

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Securing Health Data in the Cloud

One major concern that is always present when dealing with sensitive data especially in the context of health data is security. Be the Partner leverages industry leading practices to implement a highly secure environment that meets the requirements for our user’s Electronic Health Records (EHR).

To learn more about how Be the Partner addresses this challenge read our whitepaper describing our approach to securely provide health data in the cloud.

The whitepaper covers the following subjects diving into major aspects of cloud security.

  • Network Security
  • Data Encryption
  • Intrusion Prevention
  • Identity & Access Control
  • Monitoring & Logging
  • Maintenance & Compliance

To download the whitepaper, please click here.

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Where the lever can be used

If we look at statistics on the leaking patient pipeline in clinical trial recruitment and enrollment over the past 15 years, we find that the loss of patients was somewhat stable. The rate of lost patients is over 60% for pre-screening, over 30% for screening and 20% for post randomization. One rate has worsened dramatically: the percent of patients who declined consent has increased from approximately 40% to over 60%1.

One factor is the abundance of contradictory information to be found on the Internet concerning indications, treatments, and trials, and this is completely unsatisfactory for investigators.

There is need for a community platform for trial participants which offers well-vetted and targeted information to trial candidates already during pre-screening, and especially during the consent process. Patients with an account on this community platform will go home after the ICF talk with the investigator and have the chance to plunge into the matter with information suitable for lay persons. Most importantly, they can better include family and friends into the decision to give consent and participate in the trial.

Communication outside well-trodden paths on a reliable and user friendly platform where patients don’t struggle to find their way is the lever the increase number of consenting patients. This is an opportunity to quickly and effectively staunch one painful leak in the pipeline.

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Voices in the industry: What our pharmaceutical customers say about us

We are just 2 months into our #BeyondTheTrial campaign and we are proud to share our initial results. We’ve gathered additional feedback from our customers on our Platform and are happy to share some insights with you:

"Be the Partner is an excellent collaborator in building a strategic patient communication platform beyond clinical trials. Direct patient engagement through individual welcome and informational letters make it easy to connect with patients during and after the trial. As well, this platform gives us the potential to inform patients about other matching trials and to share study summary information after the trial ends."- Megan McKenzie, Associate Director, Sr. Clinical Program Lead at Genentech

Another positive response comes from one of our customers, a top tier pharma industry innovation leader at the Patient Led Clinical Trials Conference 2017, EyeforPharma, in London (May, 2017) “We partnered with Be the Partner as the platform is user friendly where patients wouldn’t struggle finding their way through. And we didn’t want the data returned to patients coming directly from our systems as this is difficult in terms of firewall and IT security, so we were looking for a third party solution.

 As our partners have demonstrated: building a global patient communication platform generates value. Be the Partner enables sponsors to recapture connectivity to trial participants and alumni of trials, as our partner illustrated below. Click here to learn more and download our whitepaper.

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Decreasing investigator burden by gaining direct access to patients

When we started our #BeyondTheTrial initiative, we spoke about the promise of building long-lasting, strategic relationships with clinical trial patients.

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