Clinical Trial Organizations

How Clinical Trial Organizations Can Convey Trust and Credibility

According to Edelman’s 2018 Trust Barometer, there’s been a global decline of public trust in the healthcare sector, which includes pharma, biotech, hospitals, insurance and consumer health. This distrust was especially noticeable in established markets including the US and France.

In this post we explore points in the clinical trial process at which trust can break down and what to do to ensure that doesn’t happen. Making patients feel supported, guaranteeing the integrity of the supply chain, and ensuring transparency and good practice are all necessary and effective means to help to convey a CTO’s credibility and trustworthiness.

Understanding Patient Distrust of Clinical Trials

It’s important to understand the source of the public’s lack of confidence, which is why Anna Hrovat-Staedter at Forte Research says clinical trial managers should familiarize themselves with the history of patient distrust. Minority populations are most impacted, she explains, but warns trial managers to acknowledge each patient has their own concerns about the trial experience.

Transparency and communication are essential. What will the trial experience be like? What should patients expect from the trial and the potential for successful treatment? These questions need to be answered clearly — and preferably in the patient’s first language.

Enhancing Pharma’s Reputation

The industry’s reputational challenges can be remedied. The starting point for this change lies in better communication with patients, says Carolyn Paul, Edelman’s global managing director for health and EMEA health chair.

The pharma industry should be making itself more available to the public and prospective patients. Companies can do more to communicate their research goals and achievements. For example, pharma companies should learn from their biotech peers to share their innovations and processes, Paul explains. What was required to develop a drug? How were the challenges overcome and why is this important? Creating a narrative of drug development is a powerful means of building credibility and trust.

The Credibility Issue of Real-World Evidence

Real-world evidence (RWE) is the goal for data acquisition for many trial managers, but it lags behind randomized controlled trials in terms of credibility. This is unfortunate, Thomas Reinke at Managed Care writes.

Part of the credibility issue — besides imprecision of data fields — is the perception that RWE research is biased and serves the interests of sponsors. Overcoming these perceptions will require greater cooperation between pharma and payers, Reinke says. The latter need more information about drugs’ safety and efficacy profiles, for instance.

Another means of improving the reputation of RWE trials would be to require sponsors to publish complete protocols  and open their studies to external audits, Reinke suggests.

Social Media to Build Trust

Social media has become an effective means to communicate with patients. More than just a powerful recruitment tool, it also enables trial managers to be social listeners, Iolanda Bulgaru at Healthcare Weekly explains.

Social listening is gathering data from social media to determine how patients feel about a trial or pharma company. This feedback tends to be more honest as it has not been directly solicited.

Tailored Marketing to Increase Credibility and Relevance

All clinical trial marketing material is an opportunity to engage with prospective patients, build trust in the process and promote credibility of the parties involved.

But marketing content should set out to answer patients’ questions, Mary K.D. D’Rozario and Nazneen Qureshi at Clinical Leader write. By providing patients with information to make informed decisions and satisfy their interest, trial managers are showing their commitment to patients.

Marketing material should engage patients using language that resonates. Using the phrase “people living with diabetes” instead of “diabetics” to describe patients reveals much about attitudes towards them, D’Rozario and Qureshi explain. Such a simple yet impactful change can be a powerful means of building trust with patients.

Tailored Credibility and Relevance

Blockchain for the Supply Chain

One of the problems when it comes to trust and credibility is not between the industry and patients but within the industry itself. Counterfeit drugs and interrupted supply chains, for example, demand more robust and digitally powered tracking systems.

This is where blockchain technology can play an important role, Alex Aves at European Pharmaceutical Manufacturer writes. Indeed, changing regulations (such as the EU’s Falsified Medicines Directive and the Drug Supply Chain Security Act in the US) require that systems improve to ensure the integrity of supply chains.

Blockchain technology would make supply chain transactions transparent and immutable, Aves says. Through IoT-based self-executing smart contracts, supply chain transactions can be set according to predefined rule to ensure good distribution practice. For instance, sensors could monitor and record package temperature during transportation and the smart contract would report any deviations from the limits.

Blockchain for Consent

A blockchain ledger would also help with the issue of patient consent, says Sophia Jelsma, project manager at technical blockchain product solutions provider, Hashed Health. Referring to the work of French researchers Benchoufi and Ravaud, blockchain technology allows each step of patient consent to be time-stamped and encoded, and assigns the patient with a private key to match their digital signature.

This proof-of-concept design provided two positive results: stakeholders were impressed by the adherence to regulatory standards and there were fewer errors in consent documentation.

Also weighing in on the blockchain for patient consent debate is David Shifrin, Ph.D. at Health:Further. He points to Benchoufi and Ravaud’s “privacy-by-design” explanation of blockchain. Think of the technology in the same way as an email list that people would opt-in to, rather than the prevalent default setting of having to opt-out. The active behaviour is akin to the signing of consent in the digital ledger, giving patients more confidence that their information will be handled responsibly and their privacy respected.

Blockchain ledger  for Consent

Lessons in Trust-Building from Biotech Companies

According to Edelman’s Trust Barometer, biotech is leading pharma when it comes to perceptions of trust, says Bruce Hayes, managing director, Health, for Edelman New York.

The study of 28 markets shows 35 percent of respondents think biotech is most likely to deliver new treatments and cure diseases. This is in stark contrast to the 13 percent that expect the same for pharma companies. Respondents generally believe biotech is more focused on innovation and R&D.

Hayes outlines six ways biotechs — and pharma — can build trust.

  • Know what your company stands for and what it aims to achieve. This will lead to better business partnerships and increased investors but also enhances reputation and builds trust.
  • Tell a story that reveals your corporate values, and engages employees, prospective partners and patients. The right narrative can help build a reputation of integrity and trust.
  • Put your technical people under the spotlight. Messaging from company staff — not marketers — will help communicate a more genuine message. They will also be able to lend greater credibility to the processes as they are the hands-on experts upon whom investors, partners and patients rely. Also, lead clinical trial investigators and chief scientific officers can play important roles in building trust with relevant stakeholders.
  • Take control of your message. The media, according to the past 18 years of the Edelman Trust Barometer, is currently at its lowest level of public trust with only 56 percent of respondents saying they trust health news reported by the media. It’s better that companies disseminate their own information, as 65 percent of respondents said they find company information credible.
  • Provide support to patients beyond delivering drug treatments. Trust can be built by helping educate patients about their diseases and the tools and support structures to help manage them.
  • Invite stakeholders inside. Opening up laboratories to interested parties will showcase the work being done and also help contextualize the cost and resources involved in drug development. This is an important means of showing patients why drugs are often very expensive.

There are clear ways for pharma companies, biotech firms and CTOs to ensure they are and appear to be trustworthy and credible organizations. Communication with patients and other stakeholders is essential. This should include conveying organizational goals, processes and plans for treatment developments as well as providing useful information for patients to manager their conditions. By catering to patients’ many needs, clinical trial managers can build credible reputations.

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