Tuesday, August 25, 2015

Pharma needs to be bolder to be truly patient-centric

By Jack Whelan

I became interested in clinical trials and how study participants interact with the drug industry after I was diagnosed with a rare and incurable blood cancer called Waldenstrom's Macroglobulinemia.

At the time of diagnosis, all the literature and on-line information indicated about a 5 year outlook after treatment began.  I was told the only treatment options available to me were chemotherapies borrowed from other blood cancers.

But I felt exploring what was available in forward-looking science, specifically clinical trials of molecular targeting agents might be safer and more effective than conventional chemotherapy. 

Seven years on I am still here and I attribute this to clinical trials - I’m currently taking part in my seventh – and my focus on communicating with drug developers as an engaged, educated partner, more commonly known as an e-Patient.

As an experienced trial participant it is my opinion that the biggest challenge facing drug firms today is data collection.

Figuring out how to gather the information needed to prove a new therapy is safe and effective in a way that is timely and complies with the rules that govern clinical trials, particularly those relating to the patient, is difficult because of the out-dated systems, procedures and assumptions about novel targeted therapies.

Many newer targeted therapies generate an immediate response, yet because clinical trial data is reported in “batch mode” rather than in real time we often fail to identify benefits or anticipate emerging adverse events until it is too late.

Although there have been advances, like the use of mobile devices to report trial data in real-time, there remain various out-of-date regulatory requirements that slow the flow of information from patient to drug developer.

As an engaged outsider, I’ve seen far too many examples where privacy and data protection regulations, such as EU Data Protection laws and the US Health Insurance Portability and Accountability Act (HIPAA) regulations, restrict information flow between patients and biopharmaceutical companies. 

Thus I believe the opportunities for more meaningful, more in-depth epidemiological studies have been hampered by too much regulation.

To solve these problems, the industry needs to become much bolder. Rather than being risk averse and trying to satisfy the perceived needs of regulators, drug developers need to instead focus on the patient’s needs.

This most regulated of industries must educate regulators to eliminate many of the out-of-date assumptions and systems that no longer apply to modern medicines.   

Many of the shortcomings of current clinical research methodologies are directly attributable to out-of-date, policies and procedures that the industry follows to achieve compliance and to earn checkmarks on a myriad of now unnecessary check-lists. 

But the underlying goal of all clinical trials remains the same; to determine the safety and efficacy of a drug based on indicators collected from patients.

We urgently need more direct contact and information flow between patients and all those who bring us new therapeutics.

I’m honoured to speak at PCT-Europe on behalf of patients from around the world whose voices might not otherwise have been heard.

PCT-Europe represents one of the best learning experiences for me personally to strive to be a more effective, knowledgeable advocate. I also see the incredible networking opportunities and the vibrant exchange of knowledge and information between collaborators and sometime competitors for the benefit of patients. 

Finally, and again on a personal note, it’s fun to be able to remind life sciences professionals about the nobility of their work and offer a sincere thank you from patients everywhere.

Jack was diagnosed with a rare, incurable blood cancer which research then indicated a five-year outlook for symptomatic patients requiring treatment. Travel with Jack on an intensely personal and oft-humorous bumpy ride on the road to Personalized Medicine still under construction. Encounter some relapsed/refractory detours, conflicting signals and biomarkers, inhibiting regulatory roadblocks and potholes in the healthcare system.  Learn why Jack, not much of beer drinker himself hangs a bottle of Guinness on his chemo infusion rack and speaker’s podium. Using business communications and research skills from his career as a Wall Street Research Analyst in Information Technology (IT) and career Sales VP in IT, he now helps bridge the communications gap between life sciences, medical professionals and patients as a Patient Advocate, Research Advocate and Legislative Advocate.

If you are eager to hear more from Jack, then make sure to register for our upcoming event here

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