Working With Industry on R&D

In addition to my roles as a patient and a clinical trial participant, I have been employed in the clinical research industry for more than a decade. During this time, I have focused on bringing the patient perspective to the research industry with the goal of designing trials that are less burdensome and more patient-friendly.

This article explores how patients can partner with industry and how these partnerships can benefit research and development and ultimately play a part in improving care. Here are a few key facts to set the stage for this discussion:

• 86% of clinical trials fail to meet projected timelines;
• More than 50% of clinical trial delays are due to insufficient patient recruitment; and
• 33% of patients drop out during the course of clinical trials.

THE UPS AND DOWNS OF WORKING WITH INDUSTRY

Over the years, I’ve participated in two migraine trials and one optic atrophy study; I’ve been prescreened for a variety of programs; I’ve considered participating in a first-in-human, inpatient trial; I’ve completed numerous user-acceptance engagements (ie, worked with product teams to figure out if what they’ve created is functional and meets expectations); and I’ve even had a few sites neglect to return my calls to express my interest in clinical trial participation (cough, COVID-19 vaccine studies, cough).

Looking back at the clinical trial interactions that I recall most fondly, a few commonalities stand out:

• The study team made it their job to keep patients engaged and make them feel valued, something that can reduce the patient dropout rate.
• Patients were always kept in the loop about study progress and next steps.
• Patient preferences and desires were respected. This included thoughtful appointment scheduling and transportation considerations, among other things.

Of course, not everything is always smiles and butterflies. Often, industry unintentionally does the following:

• It makes patients feel like commodities as opposed to valued members of the clinical trial team.
• It ignores patient barriers to participation. For example, I once spoke with a thoughtful clinical trial innovator who was providing transportation for geriatric patients with vision loss. Unfortunately, he didn’t consider that study visits were at a large, academic medical center where the trial site was half a mile from the facility’s main entrance. Needless to say, patients found this challenging.
• It fails to provide clinical trial results or return meaningful data that patients can use.
• It neglects to explain things in language patients can understand.

Although there’s some disagreement about the specifics, it takes 10 to 12 years and more than $2 billion to bring investigational products from the petri dish to the patient.¹ Depending on market share and indication, sponsors stand to lose $600,000 to $8 million for each day of delay in bringing products to market.² With these statistics in mind and the patient at the heart of drug and device development, can our industry really afford to keep making the same mistakes? How can patients and industry start to respect each other as peers and establish a more productive partnership?

STEPPING UP PATIENT INVOLVEMENT

For patients interested in putting a little more skin in the game than clinical trial participation alone, the role of patient advisor may be a good fit. Patient advisors work to incorporate the patient perspective into clinical development. At its core, this involves providing unvarnished insight into what patients are thinking in several ways:

• Advisors provide feedback on undesirable side effects such as hyperemia and ocular irritation and requirements such as the frequency of drop instillation. This type of information is gathered while treatments are in development, but additional data points are always helpful.
• Advisors offer input on in-home care and monitoring. Are these technologies that they would use? If not, why not?
• They join a patient advisory board to provide their suggestions in a structured (and fairly compensated) fashion.
• They inform industry of the resources (educational, condition-specific, or otherwise) that would be the most useful accompaniments to their at-home monitoring devices or medications.
• Advisors research opportunities to provide input on the look, feel, wording, and workflow of patient-facing applications, medication diaries, and tools.
• They offer tips for improvement. Perhaps a negative experience from a previous clinical trial really resonated with them and would keep them from participating again. Was there a need for transportation or more flexible scheduling options? This information is vital to designing more patient-friendly clinical trials.

CONCLUSION

The incorporation of patient feedback into clinical development work can lead to streamlined trials and advances in care. There are plenty of opportunities for other patients to participate with industry on research and development and to lend their unique and invaluable perspectives. I encourage those who are interested to get in touch with me.

1. A tough road: cost to develop one new drug is $2.6 billion; approval rate for drugs entering clinical development is less than 12%. Policy & Medicine. March 21, 2019. Accessed March 17, 2021. https://www.policymed.com/2014/12/a-tough-road-cost-to-develop-one-new-drug-is-26-billion-approval-rate-for-drugs-entering-clinical-de.html

2. Clinical trials and their patients: the rising costs and how to stem the loss. Pharmafile. March 11, 2016. Accessed March 17, 2021. http://www.pharmafile.com/news/511225/clinical-trials-and-their-patients-rising-costs-and-how-stem-loss