Here are some interesting insights from Avoca’s 2016 Patient Survey.

• Forty-five percent of survey respondents had participated in a clinical trial.

• Among those respondents who had participated in a clinical trial, the “ability to contribute to science” was cited as the most frequent reason for participation.

The top reasons provided for clinical trial participation did not differ significantly based on the type and impact of medical condition.

• Clinical trials are a great platform to engage patients in their health care. Two thirds of those participating in clinical trials reported feeling more educated and involved in their overall health as a result of their participation.
• Most of those surveyed had at least a fair level of confidence that trial participants are fully and honestly informed. Participants were most likely to be confident in information provided about the right to withdraw, procedures, and possible benefits, and were most skeptical about information relating to treatment alternatives, risks and side effects, and doctors’ motivations.
• Like with the confidence in information provided, most participants had at least a fair level of confidence in the compliance, caring, and ethics of the site study teams and patients involved in clinical trials; however, many were skeptical about the honesty of pharmaceutical companies and about the extent to which they cared about study patients.

• Sixty-seven percent of survey participants would recommend clinical trial participation to a loved one or friend. Among those who would recommend participation, responses carried themes of consideration of risks vs. benefits, of the institutions at which the studies are being performed, and of a wish to “do good” for society.  Among those who would not, responses generally reflected a distrust of the clinical research industry, or concerns about the possibility of receiving ineffective treatment or placebo.

In the participants’ own words, here are some of the gaps that need to be bridged by the industry to get more patients to participate and recommend clinical trials.

Interaction with patients for feedback about study design and operations

“They don’t interact with participants to get feedback on what was good or bad about the study.”

Fair compensation, and caring, respectful, and equitable treatment as participants in the research process

“While the protocol is patient-centered, the back-up and bedside manner do not always work.”

“Care about patients as people? Ha! Then why are we called ‘subjects’?? And why aren’t we compensated much better and sooner in the study? ……….Why are the visits always so inconvenient? Why aren’t there evening and weekend hours? Why aren’t staff trained in interpersonal communication, especially the chief investigating physician?”

Transparency across the board

“The medical and pharmaceutical industries’ main priority is money! When money is the most important thing, people are not told complete information. It’s a basic conflict of interest!”

“Re. doctors’ motivations, I don’t remember this particular aspect of either trial we participated in, or the various other trials I considered, ever having been mentioned.”

“I asked for feedback after the study I did participate in and never received it. I know of no-one who trusts pharmaceutical companies.” 

Overall, the results from this study indicate that as an industry, we can engage more effectively with patients on clinical trials, impacting their perceptions of clinical trial participation, and their experience.

At the Avoca Quality Consortium (AQC), we are not only sharing these results through multiple platforms, but are working diligently to weave these learnings into the creation of a “Patient Engagement Playbook” that will enable our Members to easily incorporate the patient voice into multiple stages of the clinical trial process.

To download a copy of the complete results, click here.  To learn more about our patient engagement initiatives and/or AQC membership, please contact us.

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The striking change is the spirit in which the new set of guidelines is encouraging a shift in mind set in managing quality in clinical trials. ICH E6 (R2) is calling upon legions of drug development professionals to recognize that all risks are not of equal importance from a compliance and quality perspective and the key to effectively achieving quality is through making key decisions based on a careful assessment of risk.

Risk, a term that usually tends to invoke shudders because it is all about the “possibility that something can go wrong” is now omnipresent in quality management.  Risk based approaches to oversight, monitoring, inspections and more are the new normal.

There is a lot of frenzy around understanding the guidelines.  There are a lot of processes being put in place to make sure that ICH E6 (R2) is kept at the forefront of the way clinical trial processes evolve.  My question is this.  How are organizations getting their teams to change their mindset?  As far as I can remember, the words quality and compliance were at the heart of decisions.  How does one get employees to talk about and manage risk?

Since the launch of our Avoca Quality Consortium (AQC) five years ago, we have been working with our Members to prepare for this changing environment through the raising of awareness, cross-industry dialogue and the development of proactive, tool based approaches to managing quality.  Our Members believe that the best way to approach this change is to get the conversations flowing, not just within companies, but across the clinical trial ecosystem.

At our recent AQC Member meeting with executives, we heard loud and clear that the industry is mobilizing resources to understand and respond to the new guidelines.  This is now on top of our initiatives for 2017 where we will help our Member companies to understand the implications of ICH E6 (R2), guide them with leading practices and develop tools to respond and stay ahead.

We’d love to hear your thoughts on where you are in your journey in this risk based world of quality management.

Until next time………

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

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This is a query that is routinely being asked by risk management professionals across industries.  How does an organization mitigate risk?  Risk, the dreaded possibility that something bad or unpleasant will happen.  The challenge we face in drug development is that, in many instances, we appear to be managing issues rather than risks.  Why is this so prevalent?  For one, it is sometimes easier to address a problem when it drops in front of us rather than trying to figure out the possibility that a problem will occur, the impact it could have, the resources it might take to address, and more.  Risk mitigation planning is a thoughtful, time-consuming process that requires resources.  And, as we heard earlier this year at our Avoca Quality Consortium (AQC) Summits, time/resources are a scathing challenge for drug development professionals.

The good news?  Drug development professionals know that firefighting is not a sustainable way to operate in a journey that continues to get more challenging and expensive with each passing day.  I saw this recognition and enthusiasm for change firsthand in the over 200 attendees that listened and engaged in a recent webinar entitled, “Utilizing Proactive Risk Management Mapping as an Effective Clinical Oversight Process and Tool.”  These attendees wanted to know more, asked about tools, enquired about processes, all in the interest of embracing a thoughtful way to manage risk rather than continue with the daily firefighting.

Here are some of the top-of-mind questions I heard from attendees:  Risk Mapping Webinar Q&A

If you are curious to hear the discussion in detail, you can access a recording of this webinar here:  Risk Mapping Webinar

Oh, and right as I completed this post, I happened to talk to two AQC members who are leading a seamless multidisciplinary partnership across GxPs to mitigate risk proactively and have success stories to tell.  Very encouraging indeed!

Where is your organization in this journey?  Do you believe that firefighting as a culture needs to change?  What’s standing in the way of this change?  I’d love to hear your thoughts/debates.

Until next time………

Lakshmi

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Lakshmi Sundar has spent two decades in the pharmaceutical industry, leading teams across sponsors and CROs in multiple functional areas to spark innovation, manage risk, and lead change with a sense of purpose and fun. At Avoca, Lakshmi partners with members of the Avoca Quality Consortium and industry innovators to deepen the dialogue on building a quality culture within and across organizations to mitigate risk, advance drug development, and bring treatments to patients in a more effective manner. 

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