Life Science Leader Magazine Supplements

CRO Supplement 2015

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27 LIFESCIENCELEADER.COM THE CRO LEADERSHIP AWARDS 2015 your targeted patient population, you will have to decide whether to speak to one or 50 or 500. Other questions you will need to answer are: How many times should you meet with them? How much information should you share? Should you have them sign a contract? Should you pay them and, if so, how much? Should you hire someone to be your advisor? These are all unknowns that have to be considered before engaging. When con- sidering these questions for the first time, they can be confusing and complicated, especially when undertaking them in a large organization. Without the support of management, this project will be an uphill struggle. CHOOSE THE RIGHT ADVOCATE Once you overcome these resistance chal- lenges and formulate a plan of action, finding the right person to head up your patient advocacy efforts is not going to be easy. The people who seem to have the best skills at interacting with patient advocacy groups typically lie on the com- mercial or marketing side of the house. They tend to be nonscientific, do not get involved with research, and are gener- ally not invited to trial design meetings. The M.D.s and Ph.D.s who do get invited to those meetings are used to reading scientific journals and performing scien- tific tasks. Drop in someone from patient advocacy who has spent most of their time providing grants to nonprofits and charities, and you often end up with three sides that do not even seem to be speaking the same language. "The challenge for sponsors is figuring out how to reconcile these disparate world views," says Wicks. " We are basically trying to create a patient-engagement science, three words that do not generally go together. We need to take the opinion of one patient and turn it into a repli- cable method that can be run by another sponsor, CRO, or university with similar around patient confidentiality. If a spon- sor speaks to 200 patients about a trial they are designing, there is a possibility that confidential information shared by patients might leak out somewhere. That possibility has to be properly managed from a risk point of view. "There are some real concerns here," says Wicks, "but fear of those issues might also be used by some companies as an excuse to not talk to patients. This is a real challenge to some companies that want to better engage with patients but have legal and regulatory personnel that are always quick to say no. From their viewpoint, engaging with patients is simply not worth the risk." Wicks disagrees with that point of view. He notes sponsors need to take a closer look at the legal, regulatory, and safety risks that exist from not engaging with patients. There is certainly risk of launch- ing a product no one wants. There is also risk in designing a trial that no one signs up for, or giving trial patients a drug that they refuse to take. To navigate this dilemma, he states each company will have to develop its own playbook to ensure all employees are taking the appropriate precautions. Every company will likely have a unique approach, as one size will not fit all. WHAT IS THE APPROPRIATE METHODOLOGY? Once companies get past the internal inertia and legal/regulatory blockades, they will need to develop an appropriate methodology for interacting with patients. This can also be a challenge for many sponsors. If you are preparing to move into a Phase 2 trial and want more patient involvement, what exactly do you need to do? There are a multitude of ways to elicit feedback from patients, including market research surveys, ad boards, social media listings, and more. But Wicks notes there is a playbook to be followed for each of those options. You would need to know who to commission them from, how much they cost, how effective they have been in the past, and more. Even when you decide on the best option to reach results each time. For many sponsors, that is a brave new world." A PLAN FOR SUCCESS To get patients more involved in the design of clinical trials, there will clearly be many challenges to overcome. In the long term, Wicks would like to see two things occur to make the vision more of a reality. The first is patient-centric deci- sion making being made earlier on in the drug-development process. "This should not just occur at the clinical trial level," he says. "Patients need to be brought onboard even at the point of deciding what molecules to select from the port- folio and push forward into human trials. Patients should have a voice in deciding where the real unmet needs are." Second, he would like patient participa- tion to move up what is called Arnstein's Ladder of Citizen Participation. The ladder shows who has the power to make impor- tant decisions. It goes from nonpartici- pation at the lowest level, to tokenism, and then citizen control at the highest level. Wicks would like to see more instances of patients being consulted and actually given responsibilities during the course of a trial. As an example, he cites a recent trial for breast cancer where 40 or 50 participants were added to the advisory board for the trial and given responsibility for making translations of the recruitment material. "From the patient perspective, there is a huge difference between someone from a drug company asking you for help versus the company recruiting and training you and giving you some amount of respon- sibility for the success of the study," says Wicks. "As an industry, we need to move from consulting people to actually working with them as partners. At the extreme end of this it could involve drug companies actually employing patients in advisory capacities. I believe this will be necessary to overcome the three barriers. There will no longer be that negative inertia because this effort will be done internally. We will have created a playbook that takes us through the minefield, which will give all stakeholders more confidence in the methods." L

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