Bridging the Gap between Bio-Pharmaceuticals,
CROs, Clinical Investigators and Trial Participants

Reprint from “Journal for Patient Compliance; Volume 1, Issue 2; page 37-38.”

A short while ago, I was reading a book entitled ‘WWGD?’ (‘What Would Google do?’), an interesting book on Google’s business philosophy. The authors proposed to reverse the traditional product development process. In the past, it used to be the ‘Product Development’ department who created new products based on what they felt consumers would be in need for. The authors argued that product development should start with analysing Google search trends to find out what type of products ‘consumers are searching for’. As they argued: ‘what is the purpose of developing a product if consumers are not searching for it [in Google]?’ Let’s find out if this concept can be translated into pharma, and if and how patients should impact R&D.

Patient-Centred Product Development

I will start off with an example of how patients could impact product development. It is based on a study by the Dutch Burns Foundation. Based on a survey among the treating physicians, the top 10 of aspects to study are related to cosmetic surgery or treating burned skin. Which makes sense, as that seems to be the most obvious problem patients are facing. However, for the actual patients, itching was felt to be one of the major problems. In other words, researchers were looking for answers to problems which were felt less relevant to patients, and problems which were felt as important by the patients were not investigated. This is where ‘patient-centred clinical trials’ should start, with developing treatments which ‘meet the consumer’s needs’.

It is interesting, to say the least, to see what is happening in the area of rare diseases. This is an excellent example of patient-driven research, and also an area where ‘patient meets pharma’. It is not uncommon to see patient organisations active in fundraising for research, and being actively involved in directing and organising clinical research, often in close cooperation with pharma or biotech. Needless to say, this model will reduce the chance of a mismatch between ‘product development’ and ‘consumer requirements’. Will this close interaction between patient and pharma always work? No, certainly not. Pharma is, and should be, a commercial industry with a different motivation than what drives a patient. However, Google is also a commerciallydriven company. And by placing the customer in a central position in its business process, it has grown in 13 years to a size unmatched by even the biggest pharma companies.

How can Pharma Engage with Consumers on Product Development?

Social media and web 2.0 can provide excellent tools for this interaction. Looking again outside of pharma, large consumerdriven companies have embraced tools like idea management to interact and engage with consumers. Sure, it is easier for a company like Starbucks to listen to its consumers, as everybody has something to say about coffee. Different from, say, chemotherapy to treat multiple myeloma; but even with this type of treatment, patients will be able to better balance the side-effects against the treatment effects. Most oncology trials are focusing on survival rates, the traditional outcome measurement. But what is the purpose of spending large sums of money on getting approval for a drug which most patients will refuse because they have a different angle on quality of life than pharma has? Therefore, both pharma and consumers (patients) can benefit from joint discussions on trial objectives.

Patient-Centred Clinical Trials

One of the advantages of engaging patients in an early phase of organising a new trial, is that it becomes a logical next step to involve patients, most probably patient organisations, in the practical setup of a study. Most clinical trials are the result of business negotiations between sponsor and clinical sites. This guarantees that business objectives of both pharma and investigator are met. The missing piece of the pie is in the patient’s objectives. Patient objectives are assumed to be met by the fact that a new treatment is offered. However, as soon as the burden of trial participation outweighs the actual outcome of the treatment, patients drop out, resulting in loss of ‘investment’ and usually resulting in extended trial durations.

How can this be avoided? ‘Information’ and ‘communication’are the key words. Open communication on the ‘business objectives’ of each stakeholder, including patients, will result in a better understanding of why patients are participating, and how participation and retention can be enhanced. Are patients participating because of financial payment? If so, does the financial compensation properly balance the actual ‘investment’ of the patient, like extra travel to a hospital? If not, would it require either more payment, or a different visit schedule, or can visits be scheduled closer to the patient’s home? Or is the major motive of patients related to their desire to ‘advance medicine’? If so, is there a feedback loop at the end of the study which will inform patients on study results (even if the results are not positive)? Or are patients hoping that entering a trial will give them access to a new treatment which will cure their disease? If so, have they been informed that chances of a new treatment being able to cure their disease are usually slim? Failure to understand, and take into account, the objectives of patients to participate in clinical research, can only result in loss of motivation, and finally in patients dropping out of studies.

How can Pharma Engage with Trial Subjects?

We all know that pharma is a heavily-regulated environment, therefore direct engagement with trial subjects is usually a no-go. However, this still leaves many options open to engage in a direct discussion between pharma and patient (organisations). Stepping again outside of pharma, there is a lot to learn from other industries. It is impressive to see how web 2.0 tools can enhance the interaction between companies and consumers.

In 2008 Starbucks launched MyStarbucksIdea. com and invited its customers to tell the company what it should do. One client suggested to have ice-cubicles made of coffee, in order for the coffee not to be diluted when the ice melted. An overwhelming 7600 other clients supported this idea. Translated into pharma, companies could have an online forum dedicated to a new study and open access to an invited set of patient organisations, or other stakeholders, and have them comment on study details. Similar use of these social media tools can be made during a trial or even post-trial.

A perfect example is UCB Pharma, which has teamed together with patient community PatientsLikeMe. UCB is going to use the web 2.0 tools of PatientsLikeMe to gather data about epileptics, including whether or not they are currently on a UCB treatment. The advantage for UCB is that they get longitudinal data on thousands of patients and will be able to understand the effect of different interventions on the quality of life of patients. The benefit for patients is that pharma will be able to tap into their day-to-day problems and gain a much more detailed insight into the effect of their medication. And the idea of using a pharmacovigilance person to monitor adverse events reporting (as used in the epilepsy community), could easily be transferred into actual clinical trials as well. This could solve one of the major concerns of pharma to engage in social media: adverse event reporting. If you have an independent person monitoring a patient forum, and acting on and reporting any possible adverse events, this will meet current regulations.

It is equally important to keep in mind that using social media can be as ‘open’ or ‘closed’ as needed. Most people seem to associate social media with more or less open community tools like Facebook. However, social media is only a tool which can be used in an open community, but just as well in a closed community. As an illustration, a social media tool allowing people to communicate with each other can be used to allow each stakeholder in a trial to discuss with any other stakeholder, or it could be used to allow online communication only within each ‘community’ of each individual investigator with his/her own patients. In fact, this last example is more or less what Pfizer is doing in its first-of-its-kind 100% e-trial. In this study, trial participants are able to communicate online with the researchers.

Summary and Conclusion

In conclusion, enhancing patient engagement in clinical research should not be limited to patients participating in clinical trials. It is a process of interaction between pharma and patients which starts in the early phase of study development and extends throughout the ‘lifetime’ of a new drug or treatment. We have used examples from inside and outside pharma to illustrate the potential of using social media tools to interact (‘engage’) with consumers/patients. Needless to say, this transition towards greater patient engagement will undoubtedly result in enhanced patient motivation and compliance in clinical trials. It illustrates the ongoing trend for patients to become more active in their healthcare decisions.

About the Author